New NIH Requirements: For Registering NIH-Funded Clinical Trials on Clinicaltrials.gov and for Good Clinical Practice (GCP) Training

As of January 2017, NIH has implemented two new requirements in regards to clinical trials.  These requirements are related to registering clinical trials on clinicaltrials.gov and good clinical practice (GCP) training.  In order to address these new requirements, the CRC IRB has revised the IRB forms to include sections for clinical trials registration and good clinical practice training in addition to developing processes to meet these requirements.

As these requirements are a big change, especially for social-behavioral research that was previously not subject to clinical trials registration and GCP training, we want to provide some information on how we are working to ensure compliance efficiently.  Please note that our process includes working with researchers on an individual basis and working with our colleagues outside of BU to ensure compliance, promote efficiency, and to communicate with the federal agencies.  This includes having individuals in the Research Compliance Department participate in committees and associations that bring together other universities and academic medical centers in order to work together to communicate with and address concerns to the federal agencies.  This includes participating in the following committees/associations:

  1. the Federal Demonstration Partnership (FDP) which is an association of federal agencies, academic research institutions with administrative, faculty and technical representation;
  2. the Council on Governmental Relations (COGR) which is an association of research universities, affiliated medical centers, and independent research institutes;
  3. Ct.gov national task force which is a national working group that includes members from universities, academic medical centers, and ct.gov; and
  4. the Harvard Catalyst Clinical Trials Registration & Results Reporting Subcommittee, which is a local committee that has just formed in order to address the concerns and challenges with clinical trials registration and reporting and to develop training programs.  The new NIH requirements are continually discussed at these meetings.

Currently, the CRC IRB Office has responsibility for ensuring compliance with both of these requirements on the CRC campus.  Since January, we have been working closely with researchers in order to ensure that we are in compliance with these requirements and that the process is completed efficiently.  As we move along, we will continue to update our forms and policies in addition to adding more training options and resources for both GCP training and clinical trials registration.  We will continue to work with researchers on determining if their studies meet the NIH definition of a clinical trial and will assist them with compliance.  We will update the research community as we move along.

If there are any questions regarding either of these requirements, please contact Cynthia Monahan, CRC IRB Director at cmonahan@bu.edu or 617-358-6345.

Please see additional resources below:

Please see below for a summary of the clinical trials registration requirement and the GCP training requirement:

Registering NIH-Funded Clinical Trials on Clinicaltrials.gov:  On January 18, 2017, an expanded policy of the National Institutes of Health (NIH) goes into effect that requires that clinical trials funded in whole or in part by the NIH are registered at ClinicalTrials.gov, and that results information of these trials is submitted to ClinicalTrials.gov.  Please see below for the NIH definition of a “clinical trial”:

Clinical Trial:  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 intervention on health-related biomedical or behavioral outcomes.

Of note, this requirement for registering and results reporting includes clinical trials beyond those already required by the FDA.  The requirements are expanded to include to Phase I drug studies and NIH-funded clinical trials of social-behavioral interventions.  In addition to registration requirements, compliance with requirements for regular updates and results reporting within 12 months of study closure will become mandatory.

For more information on this policy please refer to:

Good Clinical Practice (GCP) Training:  On January 1, 2017, a new policy of the National Institutes of Health (NIH) goes into effect that requires all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP).  The policy applies to all active grants and contracts, no matter what point they are in the life cycle of the trial.  While the NIH does not expect that GCP training will have been completed by January 1, 2017, the NIH does expect that investigators and staff who have not completed the training have signed up for training.  The training itself can be completed after January 1, 2017.  Please note that this applies to clinical trials only.  Please see below for the NIH definition of a “clinical trial”:

Clinical Trial:  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 intervention on health-related biomedical or behavioral outcomes.

For more information on this policy please refer to:

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