National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
UG1 Clinical Research Cooperative Agreements - Single Project
See Section III. 3. Additional Information on Eligibility.
This notice of funding opportunity (NOFO) invites applications from clinical investigators to participate in the National Drug Abuse Treatment Clinical Trials Network (CTN) and contribute to the network's capacity to respond to urgent public health needs. The National Institute on Drug Abuse (NIDA) intends to continue to develop and test interventions for addressing the wide spectrum of substance use problems via collaborative partnerships among NIDA, clinical research investigators, community representatives, healthcare providers, and healthcare institutions.
This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.
February 13 , 2024
|Application Due Dates||Review and Award Cycles|
|New||Renewal / Resubmission / Revision (as allowed)||AIDS - New/Renewal/Resubmission/Revision, as allowed||Scientific Merit Review||Advisory Council Review||Earliest Start Date|
|March 13, 2024||March 13, 2024||Not Applicable||July 2024||October 2024||December 2024|
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
This notice of funding opportunity (NOFO) invites applications from clinical investigators to participate in the National Drug Abuse Treatment Clinical Trials Network (CTN). The National Institute on Drug Abuse (NIDA) intends to continue to develop and test interventions to address a variety of substance use problems via collaborative partnerships among NIDA, clinical research investigators, community representatives, healthcare providers, and healthcare institutions.
The CTN was established in 1999 to bridge the gap between research and practice to improve substance use disorder (SUD) treatment. Through the collaborative partnership of researchers, treatment providers, and other community members, the CTN seeks to address critical research questions with direct relevance to clinical practice and the needs of people with SUDs. CTN research includes efficacy, effectiveness, and implementation research conducted primarily through multi-site clinical trials. Over the last two decades, the CTNs research infrastructure and agenda have evolved to reflect the changing landscape of the SUD treatment community, transformation of health care systems, and emerging scientific advancements.
The CTN currently is comprised of 16 Nodes, a Data and Statistics Center (DSC), and a Clinical Coordinating Center (CCC). Each Node is a primary performance site, with numerous affiliated clinical research sites. The CTN program is administered within NIDA through the Center for the Clinical Trials Network (CCTN). NIDA plans to continue supporting the CTN research infrastructure to build on the broad portfolio of research conducted in the CTN. Applications proposing new Nodes and renewals of existing Nodes are encouraged. Applications proposing Multiple Principal Investigator (MPI) collaborations to form regional consortia are especially encouraged. NIDA has an interest in extending the reach of the CTN to regions of the country that are heavily impacted by substance use and not currently represented in the Network.
Inclusion of core faculty and MPI from diverse backgrounds, including individuals from underrepresented groups in biomedical research is encouraged. NIH and NIDA support the formation of research teams that represent diverse perspectives, backgrounds (see NOT-OD-20-031 and NOT-OD-22-019), and academic and technical disciplines, as well as the submission of research applications from all eligible institutions. Applications from researchers from diverse backgrounds, including individuals from underrepresented groups across roles and positions in research are strongly encouraged to apply to this NOFO.
Plan for enhancing diverse perspectives (PEDP):
Applications responsive to this NOFO should address how their proposed Node infrastructure, including the expertise of investigators and institutional resources, could contribute to addressing key and emerging substance misuse/SUD issues in a variety of healthcare settings, in accordance with the objectives and research topics outlined below. Applicants should demonstrate their capacity to conduct large multi-site clinical trials and briefly describe a research agenda likely to have substantial public health significance and impact on clinical practice. The proposed infrastructure and research agenda should illustrate how the proposed Node could participate in the research network to improve SUD treatment and advance research in the field. Incomplete and/or non-responsive applications will be withdrawn prior to review.
Objectives of Nodes
Priority Research Topics
NIDAs priorities for SUD research topics vary over time, in response to public health needs and impacted by substance use trends, community demands, and health policy. Currently, research to speed the development and implementation of scientific solutions to the national opioid overdose public health crisis is a pressing need. Examples of high priority research topics include, but are not limited to:
Training Agenda: The CTN structure provides many opportunities for pre-doctoral, post-doctoral and junior faculty researchers to gain valuable hands-on experience in designing, participating in, and managing complex clinical trials and other clinical studies.
Community Engagement Agenda: The CTN Community Representative Council (CIRCL) provides opportunities for engaging with members from communities to inform priorities and involve communities in the process of research development.
Dissemination Agenda: Prompt and timely presentation and publication in the scientific literature of findings resulting from research undertaken in the CTN is required. CTN investigators can further disseminate research findings in collaboration with the CTN Dissemination Initiative, by developing user-friendly tools and products to facilitate the adoption of research-based interventions into clinical settings.
Organization of the CTN
Nodes: The Node is the functional unit within the CTN and resides within the grantee institution of the cooperative agreement award. The Node:
Each collaborating Node agrees to:
Principal Director(s)/Principal Investigator(s) (PD(s)/PI(s)). Nodes are led by the PD(s)/PI(s), who should be able to make a substantive and long-term commitment of effort to CTN responsibilities. The PD(s)/PI(s) are responsible for all projects conducted within their Node.
Center for the Clinical Trials Network (CCTN). The organization within NIDA responsible for scientific collaboration, administrative oversight, budgetary management, and operational management of the CTN research program.
Data and Statistics Center. The entity established under a contract awarded by NIDA to provide data management and analysis systems as required to implement and support standards established by NIDA's CCTN. The major tasks of the DSC are to:
Clinical Coordinating Center. The entity established under a contract awarded by NIDA to provide certain resources and services for CTN clinical trials and other clinical studies, including support for regulatory requirements and oversight functions mandated by NIH and DHHS. The major tasks of the CCC are to:
CTN Steering Committee. The SC constitutes the primary governing body of the CTN, with representation from each of the Nodes, NIDA, the CTN CCC, and the CTN DSC. The SC uses both standing and ad hoc committees and workgroups (e.g., RDC, Publications Committee, CTN CIRCL) to assist it in carrying out its functions. The SC meets in person at least annually, and via webinars as the need arises.
Core and Study Funds
Funding to carry out the network's research agenda falls into two categories:
Core Funds. NIDA will provide core funds directly to the Nodes on an annual basis. Core funding is the initial fixed-base funding and provides infrastructure and salary support that is not study-specific. Examples of activities supported by Core funding include, but are not limited to:
Study Funds (SF). NIDA will provide SF to the Nodes on an annual basis. SF provides support to conduct studies, including study-specific infrastructure or other requirements needed to conduct studies at a site. SF varies annually, depending on costs of ongoing studies and will be awarded to cover expenses attributable to study development, implementation, or close-out. Items supported by SF include, but are not limited to, the following study-specific expenses:
NIDA expects that equipment and services funded via Core or SF will be made available, as appropriate, for other NIDA-funded network activities regardless of how funds were initially provided to purchase those items.
Based on communications with study investigators, affiliated sites, and the DSC/CCC, the Nodes will estimate study funding needs (salary and non-salary SF) annually and submit a budget request to NIDA. NIDA will then determine the amount of SF to be provided in the coming grant year. Adjustments in SF allocation may be made at regular intervals during each budget period, based on both performance and availability of funds.
Distribution of Study Funds to Network-Affiliated Sites
SF will be distributed to the sites from the Nodes prior to enrollment of study participants following the process described above.
SF may be provided to the Node for its use and distribution to the sites to provide additional support for study-related expenses for activities that are not directly related to participant accrual.
NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.
See Section VIII. Other Information for award authorities and regulations.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Required: Only accepting applications that propose clinical trial(s).
NIDA/CCTN intends to commit up to $12,000,000 in total funds in FY 2025 to fund up to 16 awards.
Application budgets are limited to $500,000 per year in direct costs. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation.
The maximum project period is seven years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
1. Eligible Applicants
All organizations administering an eligible parent award may apply for a supplement under this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 220.127.116.11 Electronically Submitted Applications for additional information.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
3. Additional Information on Eligibility
Number of Applications
Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 18.104.22.168 Submission of Resubmission Application. This means that the NIH will not accept:
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Facilities and Other Resources. Briefly describe proposed partnerships with healthcare organizations explaining how the productivity of the network will be increased and how the partnerships will advance the objectives of the program. In addition, applicants should describe how they will integrate existing EHR data with research projects conducted through the network.
Plan for Enhancing Diverse Perspectives (PEDP)
Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:
For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Biosketches of applicants must describe their recent experience and participation in randomized clinical trials, preferably of a multicenter nature. Specific roles (PD/PI, participating site, leadership committee, lead investigator, trial design and development) should be described for each study. Publications that resulted from participation in the studies should be listed. Applicants are expected to provide evidence of their unique strengths, accomplishments, and capabilities to contribute to collaborative CTN activities. Applicants should provide evidence of expertise in the conduct of clinical trials, particularly pragmatic, randomized clinical trials. Persons responsible for participant recruitment, enrollment, data collection and data management should be shown to have extensive experience and qualifications.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The application should only request Core funding. Core funding is the initial fixed-base funding and provides infrastructure and salary support that is not study-specific. See description of Core and Study Funds in Section I above.
Study Funds (SF) should not be requested; SF will be determined and provided as studies are initiated through a collaborative process between NIDA and recipients. The process for proposing research to be conducted in the CTN is for investigators to submit a study concept for peer review to the CTN RDC, a subcommittee of the CTN SC. The CCTN Director reviews the RDCs recommendations and makes final approval decisions in consultation with NIDA leadership. If a concept is approved to move forward, a team comprised of CTN investigators, NIDA Scientific Officer(s), and DSC and CCC staff members is convened to develop a study protocol. An independent Protocol Review Board (PRB) reviews the protocol(s) and provides suggestions to NIDA. The CCTN Director considers PRB recommendations and makes final decisions regarding protocol approval for implementation or disapproval.
It is projected each PD/PI will require 2.4 - 4.2 (CY) person-months effort annually over the entire period of support to oversee the core functions of the award.
PEDP implementation costs
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Applications should propose infrastructure, including expertise of investigators and institutional resources to demonstrate capacity to conduct large multi-site clinical trials and should describe their previous experience and success in conducting multi-site clinical trials. Applications should also briefly describe a broad research agenda. The proposed infrastructure and research agenda should illustrate how the proposed Node could contribute and participate in the research network to improve SUD treatment and advance research in the field.
Applications should propose core faculty with extensive SUD expertise; expertise in successfully leading multi-site clinical trials; data science expertise; familiarity with state-level SUD treatment policies; and demonstrated active and ongoing collaboration with health systems, research networks, and/or community organizations. Inclusion of core faculty from diverse populations, including individuals from groups underrepresented in biomedical research is encouraged. Inclusion of faculty with expertise in health services, implementation science, culturally informed research methods, qualitative/mixed methods research, and health messaging research is also encouraged.
The research plan must include the following features of collaborating sites and research networks: 1) capacity to support large-scale trials of SUD prevention, treatment, and implementation interventions with an emphasis on sustainability, 2) collaboration with health systems and settings that can embed research in clinical care, 3) ability to use electronic health record data collected at clinical visits to simplify clinical trial implementation, including the identification, assessment, monitoring, and follow-up of SUD patients, 4) willingness to participate in collaborative studies with required data sharing, and 5) ability to engage patients in geographic areas highly impacted by substance use.
Node organizational structure should be described. The capacity to expand, as needed, for the conduct of specific scientific projects and related activities should be described.
Multi-Site Clinical Trial Experience
Proposed Nodes must have previous experience and success in conducting multi-site clinical trials. Applicants should provide evidence of the ability of the Node and affiliated sites to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and (4) operate within the proposed organizational structure. The applicant should include a description of current and up to 10 recently completed multicenter clinical trials involving the proposed Node. The most informative and relevant examples would be clinical trials investigating SUD treatment interventions. The summary may include clinical trials on non-SUD disease from any funding source, if judged informative by the applicant. The following metrics, when available, should be presented in tabular form for each clinical trial conducted in the past 5 years:
Applicants should briefly describe a research agenda likely to have substantial public health significance or impact on clinical practice and consistent with the goals and objectives of this NOFO (see Section 1., Priority Research Topics), which could be carried out to take advantage of the unique capabilities of the CTN. The proposed research agenda should encompass a broader set of research ideas that address current public health needs related to substance use and describe how knowledge gaps would be filled if the agenda were to be accomplished. This research agenda is not expected to be a detailed concept for a research protocol, and the proposed research agenda may not be conducted in the CTN during the funding period. The proposed vision for a CTN research agenda could be considered during the project period. The proposed research agenda should succinctly describe critical research questions that the applicant asserts must be addressed to advance scientific knowledge and have an impact on curtailing addiction related morbidity and mortality.
The brief proposed agenda should include scientific rationale and significance, main research questions; feasibility for execution in the CTN; public health impact; and proposed approaches for dissemination and implementation of findings. The applicant should describe how their expertise, experience, and current or ongoing research could be further advanced in the CTN. The applicant should provide a brief description of one exemplary study including study methods and analytic plan that could be conducted as part of the proposed research agenda.
History of Collaboration
Applicants must describe any relevant collaborative research activity undertaken between the applicant institution and proposed research partners. Contributions and collaborations in areas such as protocol design, study recruitment, data analysis and interpretation, publication and dissemination should be highlighted. Documentation of recruitment and retention rates in clinical trials should be provided.
Clinical Trial Participants
Investigators must demonstrate the ability to recruit and retain participants from populations served by their proposed healthcare providers or organizations. Potential challenges and corresponding solutions should be discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls).
Letters of Support
Applications indicating opportunities to conduct research in multiple types of medical settings and healthcare organizations are preferred. Letters of support from all healthcare organizations outside the recipient institution with whom the applicant desires to collaborate in conducting CTN-sponsored research should be included. These letters should summarize the organizations' research experience and demonstrate their capacity to conduct research. These letters should also be coupled with evidence of support for these activities from leadership of the collaborating organizations.
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
Both Renewal and New Applications must add and complete the Delayed Onset Study record and must check box "Anticipated Clinical Trial?".
Study Title-- use: "Multiple Delayed-Onset Studies"
Justification Attachment: Indicate each clinical study protocol developed during the project period will be subject to approval through a procedure that involves an initial concept submission and subsequent review by the RDC (a subcommittee of the CTN SC). If the concept receives approval from NIDA, the next stage will be development of the study protocol, which also must undergo independent peer review and receive NIDA approval prior to implementation.
Participating institutions must agree to acceptance of oversight by a single IRB of record for multi-site studies per the revised Common Rule cooperative research single IRB provision (45 CFR 46.114(b)) and/or the NIH single IRB policy, rather than local IRBs, to standardize the oversight for protection of human subjects in CTN trials, especially those operating in multiple states (https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm). Include information in the application regarding how the study will comply with the single IRB requirements prior to initiating any multi-site study in the delayed onset study justification.
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIHs electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 22.214.171.124 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applications must include annual milestones for PEDP. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following: the key personnel, environment, capacity to conduct multi-site clinical trials, and demonstrated experience in the successful conduct of multi-site clinical trials are major considerations. The proposed research agenda is a secondary consideration in evaluating the merit of this application.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Specific to this NOFO:
To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Specific to this NOFO:
To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Specific to this NOFO:
To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Does the application adequately address the following, if applicable
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this NOFO:
Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Specific to this NOFO:
To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Renewals, the committee will consider the progress made in the last funding period.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.
HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigators scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicants integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipient(s) in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipient(s) for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
Providing leadership for their Node: The Node refers to the combination of the recipient institution and the partnering health care organizations. The recipient provides scientific leadership and management of clinical trials as well as administrative and study operations services for the Node. The recipient agrees to negotiate and establish formal working relationships with healthcare organizations such as SUD specialty treatment centers, hospitals, emergency departments, healthcare networks, Federally Qualified Healthcare Centers (FQHCs), patient-centered medical homes (PCMHs), accountable care organizations (ACOs), or other entities to participate in CTN activities and conduct research and training projects. These agreements will include, at minimum: 1) a statement of work defining the goals and objectives of the research projects to be undertaken under this cooperative agreement; 2) a budget for support of the research projects that clearly identifies the personnel, equipment, materials, and other costs required to successfully conduct high quality research according to the requirements of specific protocols approved for implementation by the CTN SC and NIDA; and 3) a financial and program reporting requirement, including access to data and materials, to facilitate CTN program operation and research project oversight and monitoring. Initial agreements between the recipient institution and healthcare organizations may be more general as specific details will depend on the research projects and participating sites. The recipient will also agree to follow all CTN standards as established by the SC.
Core functions: This includes but is not limited to 1) arranging and managing the participation of partnering organizations; 2) providing scientific and technical expertise for protocol development and research operations; 3) coordinating and providing resources for activities within the Node; 4) collaborating with NIDA and other Nodes to publish and disseminate findings from CTN research projects; and 5) working with the CTN CCC and DSC. The PD/PI agrees to provide adequate support for Node personnel participation in SC and other CTN meetings as required.
Research Concept Development and Implementation: In close partnership with the partnering organizations, and in collaboration with other CTN members, the recipient develops research concepts for potential CTN trials and submits them to the CTN RDC for discussion and review, and to NIDA for approval.
Data Rights: The NIH expects investigators supported by NIH funding to make their research data available to the scientific community for subsequent analysis based on a data management and sharing plan approved as part of the award; see the NIH data sharing policy website at https://grants.nih.gov/grants/policy/data sharing. The CTN is intended as a national resource for the advancement of treatment for individuals with SUD and other affected persons. The recipient of this agreement acknowledges that NIH has access to all data generated under this cooperative agreement and the recipient agrees to provide royalty-free, nonexclusive, and irrevocable license for the government to reproduce, publish, or otherwise use the material and data derived from research conducted under this cooperative agreement. The recipient agrees to register studies in the clinicaltrials.gov database and submit results according to NIH policy (http://clinicaltrials.gov/ct2/manage-recs/fdaaa). The recipient also agrees to cooperate with NIDAs contracted DSC as requested by the CCTN with regard to (1) collection and analysis of data generated under the CTN, including but not limited to collection of PhenX Toolkit Core Tier 1 measures (https://www.phenxtoolkit.org/) and NIDA CTN common data elements (CDEs); and (2) providing timely, accurate, and complete data for purposes of monitoring the safety and progress of research projects conducted within the CTN. For each protocol, NIDA will appoint a Lead Investigator (LI). Data from all participating sites will be included in a single dataset and the dataset will be provided to the study LI. At the end of each protocol, the LI will be required to make available a public use file of all related participant-level study data. Exceptions may be made for certain types of studies or health system data. A data management and sharing plan that is consistent with CTN policies and procedures for making data available on the NIDA Data Share website must be provided and approved by the CCTN for each clinical trial or clinical study conducted in the CTN. The recipient will retain custody and primary rights to their Node data consistent with current DHHS and NIH policies, including a policy to provide public access to scientific data generated with the use of public funds upon publication, the end of the performance period, or a reasonable period after primary analysis. The recipient must agree to retain records for each completed study for a minimum of 3 years (or more if necessary) after study data lock. Each site must also comply with their respective IRB and other regulatory entities regarding records retention.
The recipient is responsible for the proper conduct of CTN studies at each site within their Node. All studies conducted in the CTN are subject to the International Conference on Harmonization (ICH) GCP guidelines. The recipient must provide resources to ensure that (1) staff receive adequate training and resources to conduct the studies; (2) the studies are conducted according to the protocol and applicable regulatory requirements; (3) the studies recruit and retain participants per approved recruitment plans, including an appropriate number of women and participants from racial and ethnic minority groups per NIH policy; (4) staff perform adequate data entry; (5) corrective actions are implemented when appropriate; (6) study materials and records are kept and/or disposed appropriately; and (7) study personnel participate in study related activities as planned by the Lead Investigator, NIDA CCTN and/or Coordinating Centers. Each study site must agree to monitoring activities that will be specified in each protocol.
In addition to periodic financial and administrative reports required by NIH for administration of this cooperative agreement, the recipient agrees to furnish the following reports according to the schedule indicated:
Investigational New Drug (IND) Reports: Recipients are required and agree to provide reports according to regulations and guidelines established by the Food and Drug Administration (FDA).
Final Study Report: Study Lead Investigators are required to provide CCTN with a Final Study Report within 120 days of data lock upon completion of the protocol. In addition, the Lead Investigator will present primary outcome results to the study DSMB or monitor(s) (if applicable), the participating sites, and the SC prior to publication.
Publication of Data:
Prompt and timely presentation and publication in the scientific literature of findings resulting from research undertaken in the CTN is required. It is expected that the Lead Investigator will complete and submit the initial outcome paper to an appropriate peer-reviewed scientific journal within 180 days of study data lock. The recipient agrees to acknowledge NIDA support in the publications and oral presentations resulting from research conducted under this cooperative agreement. Review and approval by the Publications Committee will be required for all publications and presentations. The recipient agrees to present all CTN manuscripts, abstracts, presentations, posters, and other CTN materials based on data collected as part of CTN studies or describing scientific methodology of these studies to the CTN Publications Committee for review and approval prior to the anticipated submission or presentation date.
Throughout the term of the cooperative agreement NIDA may request that a research project or study site be terminated for reasons including but not limited to: 1) insufficient participant accrual; 2) poor performance in conducting the protocol; 3) safety of the participants in the study; 4) achievement of conclusive study results; 5) emergence of new information that diminishes the scientific importance of the study question; 6) misuse of federal funds; and 7) shortfalls in appropriated funds available to pursue the study. Financial support from NIDA and access to further investigational drug supplies through this cooperative agreement will cease upon project closure, except that funds and other resources may remain available for participants already enrolled in the study.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The CCTN is the organization within NIDA responsible for scientific collaboration, administrative oversight, and operational management of the CTN research program funded by NIDA.
NIDA Program staff have substantial scientific and programmatic involvement throughout this cooperative agreement through technical assistance, and advice and coordination extending beyond normal program stewardship for grants as described below.
NIDAs Scientific Role
The Director of the CCTN will appoint NIDA Program Officers and Scientific Officers with expertise in clinical research to participate in the development of study plans and protocols, and to coordinate projects across scientific disciplines and CTN Nodes. NIDA Scientific Officers may initiate or participate in publications in accordance with established professional and NIH guidelines for authorship.
The CCTN Director, and/or designated staff, will work closely with the CTN SC to ensure that CTN efforts are consistent with NIDAs research objectives and complement other clinical research activities supported by NIDA and other organizations.
NIDA will appoint advisory boards within and outside the CTN as deemed necessary during the development and progress of protocols and studies.
For ongoing research projects NIDA Scientific Officers and NIDA's CCC and DSC will monitor study progress. NIDA and the CCC and DSC and/or the LI will prepare periodic reports profiling the conduct of the study including the safety of study participants for review by the CTN DSMB and/or other monitoring bodies as applicable. The DSMB may recommend to NIDA a need to alter, suspend, or close an ongoing study due to safety concerns, study performance issues, or early evidence of efficacy or futility.
NIDAs Role in Protocol Review and Approval
In order for a CTN research project to be initiated, a research concept must be reviewed by the CTN RDC. The NIDA CCTN Director will consider RDC recommendations and will make final decisions regarding approval or disapproval. Once a concept is presented for consideration, NIDA will evaluate the proposed project according to: NIDAs research agenda; potential impact on the science and public health; relevance to current national priorities; likelihood for timely completion; participant safety; compliance with Federal regulatory requirements; an estimated budget; and resource requirements. If a concept is approved to move forward, a team comprised of CTN investigators, NIDA Scientific Officer(s), and DSC and CCC staff members may be convened to develop a study protocol. The CCTN Director will appoint an independent PRB that will review protocols as needed and provide suggestions to the CCTN Director. The CCTN Director will consider PRB recommendations and will make final decisions regarding protocol approval or disapproval.
NIDA Access to Data
The CCTN Director, and/or designated staff or agents, shall have access to all data generated under this cooperative agreement. Monthly reports on trial progress for studies that are monitored will be prepared by the DSC and reviewed by CCTN and the study Lead Investigator. Data must be available for external checking against original source documents as required by NIDA, and Federal regulations pertaining to the responsibility of NIDA as an IND sponsor.
Monitors from the DSC and the CCC may perform periodic review of data recorded on clinical source documents, case report forms, or in electronic form. Both the DSC and the CCC are established under contracts awarded by NIDA to provide certain resources and common services for CTN clinical trials or clinical studies, as needed, including support for regulatory requirements and oversight functions mandated by NIH and DHHS.
NIDA Monitoring of Trials
All CTN studies are subject to monitoring according to protocol-specific monitoring plans. The Node must agree to periodic monitoring by CCC and DSC representatives. In addition, formal site audits will be conducted if necessary. The monitoring may include periodic on-site visits and remote document reviews by staff from the Node and the NIDA appointed Coordinating Centers to assess the following: (1) investigational drug accountability; (2) compliance with applicable federal, state and local regulations for Human Subject Research, including IRB approval and informed consent (compliance with 45 CFR 46); (3) compliance with protocol specifications; quality control and accuracy of data recording; and (4) completeness of reporting adverse events. Monitoring is conducted to assure that: the rights and well-being of participants are protected; the reported trial data are accurate, complete, and verifiable from source documents; and the conduct of the trial complies with the currently approved protocol/amendment(s), with GCP, and with all applicable regulatory requirements. Reports of all monitoring activities and audits will be reviewed by the CCTN and study performance will be reported to the DSMB. Summary reports from DSMB meetings will be provided to the Lead Investigator, who in turn will provide necessary documentation to other entities, as needed. Finally, NIDA program and grants management staff will review study accrual, and fiscal and administrative procedures. NIDA reserves the right to discontinue site participation in studies based on poor performance.
NIDA Review of Performance
CCTN will periodically review the performance of the CTN as a whole and of individual Nodes. The review will be based on information provided in periodic trial progress reports compiled from data on recruitment, retention, follow-up, treatment exposure, monitoring reports, and other factors, as well as from evaluations of site performance conducted by the CCTN staff. Insufficient patient accrual, substandard data quality, inadequate progress in executing the research agenda, or noncompliance with the Terms and Conditions of Award may result in a reduction in budget, withholding support, suspension, or termination of award.
Normal Program Stewardship
A separate NIDA Program Official other than the CCTN Director will be responsible for the normal programmatic stewardship of the award and will be identified in the Notice of Grant Award.
Areas of Joint Responsibility include:
CTN SC. The SC constitutes the primary governing body of the CTN. Membership shall comprise voting representation from each of the Nodes, the CCTN, the CCC and the DSC. The SC uses both established and ad hoc committees and workgroups (e.g., RDC, Publications Committee, CIRCL) to assist it in carrying out its functions. By accepting a Cooperative Agreement award, all participating Nodes must agree to abide by the policies and By-laws approved by the SC. The SC shall meet face-to-face at least once each year and via webinar/conference call as necessary during the year.
Protocol Review Board (PRB). An independent expert board, appointed by and reporting to the CCTN Director, that reviews proposed protocols and informed consent documents. To minimize delay and provide continuity, this board may be combined with a DSMB (see below) for a given study.
Data and Safety Monitoring Board (DSMB). An independent expert board, appointed by and reporting to the CCTN Director, that oversees and monitors the conduct of multi-site clinical trials and other clinical studies as needed to ensure the safety of participants and the validity and integrity of data. The DSMB may conduct a scientific review of a protocol if necessary (see above). The DSMB also makes an independent assessment of the research and recommends whether studies undertaken in the CTN that are monitored should continue.
Single IRB of record (IRB). To reduce the burden on local IRBs and to standardize the oversight for protection of human subjects in CTN trials, the use of a single IRB for CTN research studies is required unless an exception is granted (https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm).
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to dispute resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will consist of a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual recipient . This special dispute resolution procedure in no way affects the Recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and DHHS regulations 45 CFR Part 16.
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
Recipients will provide updates at least annually on implementation of the PEDP.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
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Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Betty Tai, Ph.D.
National Institute on Drug Abuse (NIDA)
Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
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