Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

In 2015, the Centers for Disease Control and Prevention reported that there were more than 45,000 suicide deaths in the United States, which is two and half times the number of homicide deaths in the same year. The annual suicide rate in the U.S. has continued to climb over the past sixteen years and suicide is the 10th leading cause of death, and the second leading cause of death in individuals age 10-34. Compounding the impact of this preventable loss of life, the rate of nonfatal suicide attempts is many times higher than the rate of suicide death and the economic impact of suicidal behaviors has been estimated to exceed more than $40 billion annually in the U.S. Our ability to understand the mechanisms that confer proximal risk for suicidal behavior remains a challenge. Prior research in this field has focused on single sociodemographic and psychiatric risk factors, primarily examined risk factors that are distal from suicidal behavior and not specific to suicide, and have not considered time-variant factors. New approaches are needed to rapidly identify who is most at risk, why people transition from suicidal thoughts to action, and identify targets for novel interventions for rapid reduction of high risk states.

In June 2016, in a continuing effort to engage experts focused on discovering and understanding the variety of behaviors and markers of suicidal behavior, the NIMH sponsored a workshop entitled Mechanisms Underlying Suicide Risk: Integrating Research Domain Criteria (RDoC) to Inform Novel and Personalized Interventions. With input from NIDA, NICHD, and NIAAA, a multidisciplinary group of researchers convened to consider how approaches consistent with the RDoC framework could provide new insight on underlying mechanisms of suicide risk. The RDoC framework is particularly relevant because suicidal thoughts and behaviors are transdiagnostic, and measurement of suicidal processes need to expand beyond self-report and focus on clinical symptoms. Two important suggestions emerged from the workshop: 1) It is important to look beyond single psychological and demographic factors or even single RDoC function domains and focus instead of the interaction of multiple domains and 2) The ability to accurately predict suicide behaviors must incorporate analysis of time-varying risk factors and focus on imminent/proximal risk (versus distal risks).

A recent meta-analysis of 365 studies that examined longitudinal prediction of specific suicide thoughts and behaviors outcomes from sociodemographic and clinical diagnostic risk factors found that no single broad category or subcategory accurately predicted far above chance levels. Accurate prediction of suicide behaviors will likely require a complex combination of a large number of factors, across multiple levels of analysis, sensitive to dynamic changes across developmental stage and short-term (e.g. hours, days) temporal variation. The meta-analysis found that Arousal and Sleep/Wakefulness Patterns increased risk for suicide attempt at comparable degrees to Depressed Mood and Rumination. While the NIMH portfolio has supported studies that examine the RDoC domain of Negative Valence and suicide risk, fewer projects have examined the Arousal and Regulation domain and suicide risk.

The primary goal of this FOA is to solicit applications that propose to inform our understanding of proximal risk for suicide. Risk is a dynamic process and suicide attempts are often preceded by acute stressors. While many studies of suicide risk focus on emotion dysregulation, fewer studies have examined arousal and regulation and how these domains dynamically shape emotional and cognitive functions such as response to reward, frustrative non-reward, cognitive flexibility and control, or decision-making. Very few studies in the NIMH portfolio on suicide risk have focused on proximal risk. This FOA seeks research that will address these gaps by providing an understanding of the mechanisms of how dysregulation interacts with cognition and negative and positive valence in order to determine time-varying risk, and identifying modifiable targets for timely interventions during high risk periods. For this FOA, the working definition of proximal risk is dynamic factors that occur on the order of hours, days, and weeks. Because the primary focus of the FOA is to reveal key mechanisms that determine imminent/proximal risk, approaches that harness technologies such as smart phones, wearable devices, and actigraphy, to assess behavior, physiological state, and thoughts with fine temporal resolution (e.g. hours, days) in naturalistic setting are encouraged, as are computational approaches that quantify and predict risk state.

This effort is consistent with NIMH Strategic Research Objective 2 which seeks to chart mental illness trajectories to determine when, where, and how to intervene as well as Objective 3 which strives to develop new treatments or tailor existing treatments for personalized interventions. It is consistent with NIDA strategic priorities, including an emphasis on addressing real world complexities of substance use and substance use disorders, such as psychiatric comorbidities (including within the context of overdose deaths), and increasing the public health impact of NIDA supported research (Goal 4). This FOA also speaks to multiple objectives in the Prioritized Research Agenda for Suicide Prevention: short-term objective 1.B aimed at identifying biomarkers and interactions associated with current and future risk; short-term objective 1.C aimed at identifying cognitive dysfunction/neural circuitry profiles associated with risk that may be amenable to current intervention; long-term objective 1.C which specifically sites insomnia as an area of investigation; and objective 2.B which aims to develop improved decision-making tools.

Applications submitted in response to this FOA must explicitly explore how interactions between at least one construct in the domain of arousal and regulation and one or more constructs in other RDoC domains are linked to imminent risk for suicide ideation, behaviors, and attempts (including interrupted or aborted attempts). Studies that are focused solely on static suicidal traits, past behavior, or distal risk will not be considered responsive to this FOA. To be responsive to this FOA,, applications must integrate at least two levels of analysis (e.g. behavior/cognition, neural circuits, genetics, molecular and cellular processes), consistent with the RDoC Framework. Investigators are encouraged to include transdiagnostic samples, when appropriate.

Examples of projects that might be appropriate for this FOA seeking constructs associated with suicide ideation, behaviors, and attempts include investigations that examine:

• efforts to harness technologies such as smart phones, wearable devices, and actigraphy, to assess behavior, physiological state, and thoughts with fine temporal resolution (e.g. hours, days) in naturalistic settings
• sleep-related modulation of cognitive and/or emotional domains
• disordered eating or substance use and dynamic effects on other RDoC functional domains
• contextually inappropriate reactivity to external and internal stimuli and how it modulates affective processing, cognition, and decision-making
• dysregulation following childbirth and its relation to mood, motivation, and cognition
• changes in arousal and regulation in response to behavioral, pharmacological, or neuromodulatory interventions and consequent effects on domains such as decision-making, risk-taking,and perspective-taking
• heightened sensitivity in response to social interactions including contagion by negative reports in social networks
• proximal risk factors that arise during specific sensitive periods in development or reflect differences between males and females.

Studies appropriate for this FOA may include studies which are not clinical trials, as well as those which would be considered mechanistic clinical trials that include pharmacological, physiological or behavioral manipulations of known efficacy in order to understand the pathophysiology of mental disorders. See: https://grants.nih.gov/grants/guide/notice-files/NOT-MH-18-004.html. . Studies that are early-stage trials of novel treatments or tests of clinical efficacy/effectiveness will be considered to be unresponsive for this RFA.

Pilot data are not required, but if a project is high-risk with limited preliminary results, it should be supported by a sound rationale as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful. In developing projects, applicants should consider what data in their application can be publicly shared. When possible, investigators funded by NIMH under this FOA are expected to share data via the NIMH Data Archive (https://data-archive.nimh.nih.gov/ndct/about). The NIMH Data Archive is willing to work with applicants to determine what data can be shared (e.g., electronic medical record data; National Death Index acquired data). The NIMH Data Archive can also provide a private cloud-based storage site that will facilitate the proposed work. Applicants who are interested in exploring this possibility should contact the NIMH Data Archive help desk ([email protected]). To facilitate aggregation of data across studies in publicly shared databases, NIMH strongly encourages investigators to include common data elements such as the PhenX Suicide Specialty Collection (https://www.phenx.org/node/4).

Protection of Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. NIMH has recently updated issues to consider in conducting research with individuals at risk for suicide: https://www.nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers.shtml.
The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. Additionally, the NIH has recently issued new guidelines for clinical research: https://grants.nih.gov/policy/clinical-trials.htm

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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 FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. 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 SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Stacia Friedman-Hill, Ph.D
?National Institute of Mental Health
Telephone: 301-443-8458
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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.

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular 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.

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:

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.
The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

In order to advance the goal of furthering research by widespread data sharing among researchers, clinical trials funded under this FOA are expected to share those data via the National Database for Clinical Trials related to Mental Illness (NDCT; http://ndct.nimh.nih.gov/; see NOT-MH-14-015 and NOT-MH-15-012). Applicants should explain what type of data are appropriate and available for sharing in the NDCT.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

4. Submission Dates and Times

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, NIH’s 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 Policy on Late Application Submission.

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 SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s 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 NIMH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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).

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.

In addition, for applications involving clinical trials

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?

In addition, for applications involving clinical trials

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?

In addition, for applications involving clinical trials

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?

How well does the application explicitly explore how interactions between at least one construct in the domain of arousal and regulation and one or more constructs in other RDoC domains are linked to imminent risk for suicide attempts? To what extent does the project integrate at least two levels of analysis (e.g. behavior/cognition, neural circuits, genetics, molecular and cellular processes)? How well does the project utilize transdiagnostic samples, if appropriate?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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 ? 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?

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?

In addition, for applications involving clinical trials

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?

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.

Study Timeline

Specific to applications involving clinical trials

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)?

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.