Accelerating Discovery to Improve Human HealthThe CCTS offers a broad array of research trainings, programs, services, and collaboration opportunities to help clinical and translational investigators accelerate the pace and impact of their discoveries. We believe scientific excellence is of critical importance not only to the health of our populations, but also the future of our research enterprise.
As the federal government implements several new policies in 2017 to improve the quality, efficiency, and transparency of clinical trials, we stand ready to help research teams understand and meet the resulting requirements. Some are new and some are old, but stiffened by the addition of monetary penalties. All require rapid adaptation.
Below we highlight specific regulatory changes and provide a list of resources (both CCTS and external) offering guidance and support. Questions? Concerns? Need a more targeted solution to thorny regulatory issues? Email email@example.com.
NIH Policy ChangesAll 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).
The 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.
Walk-in clinics to discuss ClinicalTrials.gov requirements available the 2nd and 3rd Wednesdays of the month, 11:30am-1pm, at PCAMS.
Consultations also available on request, email CCTS Director of Clinical Research Support Program Penny Jester to schedule.
Research Seminar Series: How to Register a Protocol in ClinicalTrials.gov, Mar. 16, 11am-1pm PCAMS
CCTS Digest Briefs
Oct. CCTS Forum Highlights Resources to Support Excellence in Fulfilling New Federally Funded Clinical Trial Policies
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)