New Requirements for Clinical Trials
Effective July 19, 2018: For each clinical trial conducted, one IRB-approved informed consent form used to enroll subjects must be posted on a publicly available Federal website. The informed consent form must be posted after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
Effective January 25, 2018: Applicants seeking NIH funding for a clinical trial will be required to submit the application through a Funding Opportunity Announcement (FOA) or Request for Proposal (RFP) that accepts clinical trials. Applicants will also be required to use the new PHS Human Subject and Clinical Trial Information Form (part of the NIH funding application package, Forms-E).
All clinical trials (both funded and unfunded) that fall under the following definition must be registered on ClinicalTrials.gov:
- A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. This includes Phase 1 clinical trials, and trials that do not involve any FDA-regulated products (such as trials involving only behavioral interventions).
Learn more about the ClinicalTrials.gov Registration process
Good Clinical Practice (GCP) Training
All researchers that are engaged in conducting one or more of the following types of research studies are required to complete online GCP training (in addition to the regular CITI IRB training):
- An NIH funded clinical trial; or
- An FDA regulated clinical trial involving drugs, devices, or biologics.
GCP training can be completed through the CITI Program website. GCP training reports are valid for a period of three years and must be renewed at the end of that three year period.
Other Clinical Trial Resources