Training Resources - NIH Clinical Trial Policies

Learn about training opportunities and use the resources below to help spread the word about NIH's clinical trial policies. We will be posting a number of additional resources soon, so check back frequently!

 

Slide Decks

Feel free to use these slides for your own outreach. Use just a slide or two or the whole deck.

Presentation on rationale: NIH Clinical Trials and Transparency Reforms. Why the Changes?
 

16 slides

PowerPoint (6 MB)

Posted
9/7/2017
 
Brief overview presentation Doing Human Subject Research? Changing NIH Policies May Impact You. 
 
13 slides
 
PowerPoint (1.7 MB)
 
Updated
9/25/2017
 
Full length presentation: Doing Human Subject Research? Changing NIH Policies May Impact You.
31 slides PowerPoint (1.3 MB)
Updated  
9/25/2017


Flyer
 


2 Sided Flyer
 
This flyer highlights the definition of a clinical trial and provides a brief summary of clinical trial policy changes.
 
PDF
 
Updated
9/8/2017


Human Subjects/Clinical Trial Questionnaire 

Use this questionnaire to help your team answer the question, "Does your human subjects research study meet the NIH definition of a clinical trial?"
                              Your human subjects study may meet the NIH definition of a clinical trial.
 

                                                                                    


Trainings

Single IRB & Exceptions Process Webinar
October 18, 2017          


Videos

Sometimes a simple explanation with a video is all you need. We are planning a series of videos. This page will be updated with our plans very soon.

   
Overview of New NIH Policies on Human Subjects Research






https://grants.nih.gov/policy/clinical-trials/tutorial/story.html



 



Duration:
  15 min

A Walk Through the PHS Human Subject and Clinical Trial Information Form 
https://grants.nih.gov/policy/clinical-trials/new-form/video      Duration:
 9 min 
Decorative image link to the video: How to choose th right FOA
How to Choose the Right FOA
https://grants.nih.gov/grants/how-to-apply-application-guide/video/choose-FOA/story_html5.html  Duration:
 12 min 


Podcasts

Changes to the NIH Appendix Policy for 2018 (MP3 & Transcript)

December 29, 2017

Why it's so important to Submit Applications Early (MP3 & Transcript) December 29, 2017
Understanding the Definition of a Clinical Trial and What that Means for You (MP3 & Transcript) October 17, 2017


Open Mike Blogs from Dr. Mike Lauer, NIH Deputy Director for Extramural Research

Further Refining Case Studies and FAQs about the NIH Definition of a Clinical Trial in Response to Your Questions January 4, 2018
Be Careful to Pick the Right Funding Opportunity Announcement (FOA) December 7, 2017
Implementing a New Human Subject and Clinical Trial Information Form October 11, 2017
Continuing to Clarify the NIH Definition of a Clinical Trial September 8, 2017
4 Questions For Researchers and Institutions Involved In Human Subjects Research August 11, 2017
Direct email to NIH PIs, recent applicants, and research administrators August 11, 2017


Guide Notices

Clinical Trial Definition

NOT-OD-16-149 NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information September 16, 2016


Clinical Trial Funding Opportunity Announcements

NOT-OD-18-106 Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018

November 30, 2017

NOT-OD-18-010 NIH Plans for Clinical Trial Specific Parent R01 and Parent R21 Funding Opportunity Announcements October 25, 2017
NOT-OD-17-043 Update on Clinical Trial Funding Opportunity Announcement Policy February 17, 2017


Clinical Trial Review Criteria

NOT-OD-18-109 Revision: The NIH Announces New Review Criteria for Career Development Award Applications Involving Clinical Trials  December 1, 2017
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 October 6, 2017

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

October 6, 2017

NOT-OD-17-118 The NIH Announces New Review Criteria for Research Project Applications Involving Clinical Trials February 17, 2017
 

Human Subjects and Clinical Trial Information form

NOT-OD-18-128 Grant Application Instruction Correction for Training Grants with Human Subjects Involvement January 18, 2018
NOT-OD-17-119 New NIH "FORMS-E" Grant Application Instructions Available for Due Dates On or After January 25, 2018 September 25, 2017

NOT-OD-17-062 New NIH "FORMS-E" Grant Application Forms and Instructions

April 27, 2017

 

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. January 12, 2018
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. August 2, 2017
 

Protocol Template

NOT-OD-17-064 NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials May 2, 2017   
 

Good Clinical Practice

NOT-OD-16-148​ Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials September 16, 2016
 

Single IRB Policy

NOT-OD-18-004 Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research October 11, 2017
NOT-OD-18-003 Guidance on Exceptions to the NIH Single IRB Policy October 11, 2017
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 June 16, 2017
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 June 21, 2016  
NOT-OD-16-094  Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research June 21, 2016


Registration & Reporting

NOT-OD-16-149 NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information September 16, 2016