NIH Policy Changes

All clinical trial grant applications and contract proposals submitted on or after January 18, 2017, whether funded in whole or in part by the NIH, must be registered at ClinicalTrials.gov within 21 days of first-patient enrollment. Penalties will be enforced for delinquent registration.* (42 CFR Part 11)

Clinical Trials Reporting

All clinical trial outcomes, whether funded in whole or in part by the NIH, must be submitted to ClinicalTrials.gov within one year of trial completion (defined as the 12 months after the last subject has met his or her primary endpoint). Investigators will have 25 days to respond to queries related to results reporting. As of January 18, 2017, penalties will be enforced for delinquent results reporting.* (NOT-OD-16-149)

*Penalties include fines and loss of federal funding for both institution and investigator. Noncompliance will also be publicly posted on ClinicalTrials.gov. 

Good Clinical Practice

As of Jan. 1, 2017, NIH expects investigators in NIH-supported clinical trials, and staff who design, oversee, manage, or conduct clinical trials, to receive training in GCP. Documentation should be retained and must be provided at NIH request. Once basic GCP training is completed, a refresher course is required every three years. (NOT-OD-16-148).

CITI ProgramThe CCTS Hub and many other institutions accept the Collaborative Institutional Training Initiative (CITI) GCP Training to fulfill this important requirement. Please check with your local IRB to find the right course for you.

Single IRB (sIRB)

As of May 25, 2017, multisite studies will be required to use a single Institutional Review Board (sIRB) of record for the ethical review of non-exempt human subjects research (NOT-OD-16-094). The CCTS Partner Network has signed on to SMART IRB to provide the needed infrastructure for IRB reliance in multisite investigation.

CCTS Resources

Consultations are available on request, email This email address is being protected from spambots. You need JavaScript enabled to view it. to schedule. 
CCTS Digest Briefs

External Resources

How to Apply for a Protocol Registration and Results System (PRS) Account (the database for registering a study and entering results on ClinicalTrials.gov)
How to Submit Your Results (includes an overview of ClinicalTrials.gov database, the information review process, presentations on each of four required modules, and how to edit/update a record)
FAQ on the Protocol Registration and Results System (the database for entering results on ClinicalTrials.gov)
Training Materials (Final Rule webinar, overview of ClinicalTrial.gov and related policies, submitting results data, train the trainer workshop slides, example studies for Results Data Entry)
smart irb
Policy Links

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