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Clinical Research/Trial Policies & Effective Dates
Policy & Guide Notice
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Effective Date
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Revised Clinical Trial Definition
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Effective for competing grant applications and contract proposals that are submitted to NIH for due dates on or after January 25, 2015
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Inclusion of Children in Clinical Research: Change in Age Definition
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Effective for applications and proposals submitted for due dates on or after January 25, 2016
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Certificates of Confidentiality (CoC) Policy Update
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Effective for any NIH-funded project that was ongoing on or after December 13, 2016
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Good Clinical Practice (GCP) Training Requirement for NIH Awardees
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Effective January 1, 2017 for all staff and investigators involved in the design, conduct, oversight, or management of clinical trials
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Dissemination of NIH-Funded Clinical Trial Information (ClinicalTrials.gov Registration & Reporting Policy)
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Effective for applications requesting support for a clinical trial that will be initiated on or after January 18, 2017
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Clinical Trial-Specific Funding Opportunity Announcement (FOA) Requirements
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Effective for applications with due dates on or after January 25, 2018
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FORMS-E Application Instructions
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Effective for applications with due dates on or after January 25, 2018
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Single IRB for Multi-Site Trials
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Effective for applications with due dates on or after January 25, 2018 and for contract solicitations published on or after January 25, 2018
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Inclusion Across the Lifespan (revision to the Inclusion of Children Policy)
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Effective for all competing grant applications for due dates on or after January 25, 2019
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Guide Notices
Flexibilities for Prospective Basic Experimental Studies with Human Participants
NOT-OD-19-126 Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants
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July 24, 2019
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NOT-OD-19-024 Notice of Intent to Publish Parent Funding Opportunity Announcements for Basic Experimental Studies with Humans.
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October 26, 2018
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NOT-OD-18-212 Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants.
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July 20, 2018
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Clinical Trial Definition
NOT-OD-15-015 Notice of Revised NIH Definition of "Clinical Trial"
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October 23, 2014
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Clinical Trial Funding Opportunity Announcements
NOT-OD-18-106 Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018
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November 30, 2017
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NOT-OD-18-010 NIH Plans for Clinical Trial Specific Parent R01 and Parent R21 Funding Opportunity Announcements
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October 25, 2017
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NOT-OD-17-043 Update on Clinical Trial Funding Opportunity Announcement Policy
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February 17, 2017
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Clinical Trial Review Criteria
NOT-OD-18-109 Revision: The NIH Announces New Review Criteria for Career Development Award Applications Involving Clinical Trials
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December 1, 2017
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NOT-OD-17-123 The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants Involving Research Experiences in Clinical Trials
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October 6, 2017
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NOT-OD-17-122 The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Applications Involving Research Experiences in Clinical Trials
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October 6, 2017
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NOT-OD-17-118 The NIH Announces New Review Criteria for Research Project Applications Involving Clinical Trials
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September 21, 2017
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Human Subjects and Clinical Trials Information form
NOT-OD-18-128 Grant Application Instruction Correction for Training Grants with Human Subjects Involvement
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September 25, 2017
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NOT-OD-17-062 New NIH "FORMS-E" Grant Application Forms and Instructions
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April 27, 2017
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Appendix Policy for Clinical Trial-related Materials
NOT-OD-18-126 Reminder: Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018.
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January 12, 2018
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NOT-OD-17-098 Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018.
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August 2, 2017
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Protocol Template
NOT-OD-19-092 NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans
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March 26, 2019
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NOT-OD-17-064 NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials
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May 2, 2017
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Good Clinical Practice
NOT-OD-16-148 Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
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September 16, 2016
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Single IRB Policy
NOT-OD-20-058 Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
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January 22, 2020
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NOT-OD-18-004 Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
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October 11, 2017
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NOT-OD-18-003 Guidance on Exceptions to the NIH Single IRB Policy
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October 11, 2017
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NOT-OD-17-076 Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
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June 16, 2017
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NOT-OD-16-109 Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research
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June 21, 2016
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NOT-OD-16-094 Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
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June 21, 2016
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Registration & Reporting
NOT-OD-16-149 NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
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September 16, 2016
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Human Subjects System (HSS)
NOT-OD-18-179 Transition from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018
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May 11, 2018
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This page last updated on April 15, 2019