Issued by
National Institute on Dental and Craniofacial Research (NIDCR)

Purpose

This notice updates PAR-18-656 "NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) to move the application due date to July 9, 2018 and to modify two PHS Human Subjects and Clinical Trials Information form instruction issues.

Specific FOA changes are as follows:

1. Change to initial Application Due Date for new applications

Currently reads (per NOT-DE-18-011)

Application Due Date(s)

New applications - June 6, and October 4 of 2018; February 6, June 6 and October 8 of 2019; February 6, June 8, and October 6 of 2020 by 5:00 PM local time of applicant organization.

Modified to read

Application Due Date(s)

New applications - July 9, and October 4 of 2018; February 6, June 6 and October 8 of 2019; February 6, June 8, and October 6 of 2020 by 5:00 PM local time of applicant organization.

2. Combine the two attachments mentioned for field 2.7 Study Timeline of the PHS Human Subjects and Clinical Trials Information form into a single attachment

Currently reads

2.7 Study Timeline

The filename "Study Timeline" should be used to name this attachment. Applicants are encouraged to use the template (Appendix A) in the NIDCR Clinical Trial (Interventional) Protocol Template. Provide the proposed trial's schedule of events capturing time points and planned activity at study visits. For example:

• Screening Visit: Assessment of Eligibility Criteria, complete Informed Consent process;

• Baseline Visit: Randomize to condition, administer baseline questionnaires, and/or laboratory task(s);

• Weeks 2, 3, 4, 5, and 6 Study Visit(s): Administer intervention(s), administer study questionnaires, lab tasks, and/or other assessments;

• Weeks 12 and 24 Follow-up Study Visit(s). Administer final study questionnaires, lab tasks, and/or other assessments.

The study Study Timeline should include acceptable time windows for each activity.

Applications that lack the Study Timeline are considered incomplete and will be withdrawn without peer review.

Milestone Plan. The filename "Milestone Plan" should be used to name this attachment. The Milestone Plan must describe separate milestones for the UG3 and UH3 phases.

Applicants are required to provide detailed project performance and timeline milestones. This attachment must include two sections: those milestones to be completed during the UG3 planning phase and those to be completed during the UH3 phase. The plan should present an overview of the project timeline for the following general milestones, as applicable:

Milestones to be completed during the UG3 phase:

• Demonstration that the intervention engages the behavioral or social target it is hypothesized to engage;

• Demonstration that intervention target engagement can be measured;

• Collection and analysis of any data to assess the acceptability of the study intervention(s) to the target population and target interventionists (if applicable);

• Collection and analysis of any data to assess the acceptability of study procedures to the target population, and the feasibility of study procedures in the target setting(s) and for the target interventionists (if applicable);

• Finalization of agreements for use of resources available within CTSAs, practice-based research networks, patient registries, etc.;

• Finalization of clinical protocol;

• Acceptance of the protocol by NIDCR;

• Regulatory approvals (IRB and applicable oversight committees);

• Completion of the data management system;

• Finalization of all documents necessary to implement the trial, such as case report forms;

• Registration of clinical trial in ClinicalTrials.gov.

Milestones to be completed during the UH3 phase:

• Site activation;

• Enrollment of the first subject;

• If applicable, enrollment and randomization, of 25%, 50%, 75% and 100% of the projected study population;

• Completion of data collection;

• Completion of primary study analyses;

• Completion of final study report.

Applications that lack the Milestone Plan are considered incomplete and will be withdrawn without peer review.

Modified to read

2.7 Study Timeline

Filenames must be unique within the application. The filename "Study-X-Timeline-and-Milestone-Plan" should be used to name this attachment where X is the study number. For example, use Study-1-Timeline-and-Milestones for the filename when attaching the PDF to the 2.7 Study Timeline field in Study 1. Organize the attachment into two sections using the headings Study Timeline and Milestone Plan . Applications that lack either section of the Study-X-Timeline-and-Milestone-Plan are considered incomplete and will be withdrawn without peer review.

Study Timeline

Applicants are encouraged to use the template (Appendix A) in the NIDCR Clinical Trial (Interventional) Protocol Template. Provide the proposed trial's schedule of events capturing time points and planned activity at study visits. For example:

• Screening Visit: Assessment of Eligibility Criteria, complete Informed Consent process;

• Baseline Visit: Randomize to condition, administer baseline questionnaires, and/or laboratory task(s);

• Weeks 2, 3, 4, 5, and 6 Study Visit(s): Administer intervention(s), administer study questionnaires, lab tasks, and/or other assessments;

• Weeks 12 and 24 Follow-up Study Visit(s). Administer final study questionnaires, lab tasks, and/or other assessments.

The Study Timeline section should include acceptable time windows for each activity.

Milestone Plan

The Milestone Plan must describe separate milestones for the UG3 and UH3 phases.

Applicants are required to provide detailed project performance and timeline milestones. This section must include two sub-sections: those milestones to be completed during the UG3 planning phase and those to be completed during the UH3 phase. The plan should present an overview of the project timeline for the following general milestones, as applicable:

Milestones to be completed during the UG3 phase:

• Demonstration that the intervention engages the behavioral or social target it is hypothesized to engage;

• Demonstration that intervention target engagement can be measured;

• Collection and analysis of any data to assess the acceptability of the study intervention(s) to the target population and target interventionists (if applicable);

• Collection and analysis of any data to assess the acceptability of study procedures to the target population, and the feasibility of study procedures in the target setting(s) and for the target interventionists (if applicable);

• Finalization of agreements for use of resources available within CTSAs, practice-based research networks, patient registries, etc.;

• Finalization of clinical protocol;

• Acceptance of the protocol by NIDCR;

• Regulatory approvals (IRB and applicable oversight committees);

• Completion of the data management system;

• Finalization of all documents necessary to implement the trial, such as case report forms;

• Registration of clinical trial in ClinicalTrials.gov.

Milestones to be completed during the UH3 phase:

• Site activation;

• Enrollment of the first subject;

• If applicable, enrollment and randomization, of 25%, 50%, 75% and 100% of the projected study population;

• Completion of data collection;

• Completion of primary study analyses;

• Completion of final study report.

3. Update filename instructions for the Clinical Monitoring Plan attachment in section 5.1 of the PHS Human Subjects and Clinical Trials Information form

Currently reads

5.1 Other Clinical Trial-related Attachments

In addition to Sections 1, 2, 3 and 4 of the Study Record: PHS Human Subjects and Clinical Trials Information, the application must contain the following Other Attachment (Clinical Monitoring Plan), prepared according to the instructions below, to provide evidence that the investigator(s) are ready to proceed with a clinical trial. The information provided here supports the Research Strategy and should not duplicate it. The following document must be uploaded as a separate pdf file with the name indicated below.

Clinical Monitoring Plan. The filename "Clinical Monitoring Plan" should be used to name this attachment. Applicants are encouraged to read "NIDCR Clinical Monitoring Guidelines" for an overview of the practice of clinical monitoring.

Modified to read

5.1 Other Clinical Trial-related Attachments

In addition to Sections 1, 2, 3 and 4 of the Study Record: PHS Human Subjects and Clinical Trials Information, the application must contain the following Other Attachment (Clinical Monitoring Plan), prepared according to the instructions below, to provide evidence that the investigator(s) are ready to proceed with a clinical trial. The information provided here supports the Research Strategy and should not duplicate it. The following document must be uploaded as a separate pdf file with the name indicated below.

Clinical Monitoring Plan. Filenames must be unique within the application. Use filename "Clinical-Monitoring-Plan-Study-X.pdf" where X is the study number. For example, use "Clinical-Monitoring-Plan-Study-1.pdf for the filename when attaching the Clinical Monitoring Plan in Study 1.

Inquiries

Please direct all inquiries to:

Melissa W. Riddle, PhD
National Institute of Dental and Craniofacial Research
Division of Extramural Research
Telephone: (301) 451-3888
Email: [email protected]