Clinical Trials Compliance
If you are looking for information on industry-sponsored or privately funded clinical trials, please contact the Research Compliance Unit Mailbox.
What is a Clinical Trial?
In 2015, NIH changed the definition of clinical trial to “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.”
To qualify as a clinical trial, a study must meet all of these criteria. Research that involves individuals who are no longer living, studies of existing biological specimens collected for another purpose, or research that seeks to define an existing measure are some examples of studies that are not clinical trials.
If you aren’t sure whether or not your study is a clinical trial, use the NIH Decision Tool.
NIH Single IRB (sIRB) Requirement
An NIH-funded clinical trial being conducted at more than one site within the U.S. may be subject to the NIH Single IRB policy. This policy does not apply to non-U.S. sites. There are also certain NIH awards that are exempt from this policy, specifically career development (K), institutional training (T), and fellowship (F) awards.
Any IRB that serves at the sIRB of record for NIH-sponsored research must be registered with the HHS Office of Human Research Protections (OHRP) and must have adequate expertise to review the proposed study.
Please note that the SJSU IRB is not currently registered to serve as the sIRB of record for multi-site NIH-sponsored research. You may use an institutional IRB that is associated with a co-investigator, one of the participating sites, or a commercial IRB. It is very important that you work with your co-investigators to identify an sIRB as early in the proposal process as possible, as there may be costs associated with sIRB review. These costs should be included in your budget.
Training in Good Clinical Practice
You must have training in Good Clinical Practice (GCP) if you are an investigator or clinical trial staff responsible for the conduct, management, or oversight of an NIH-funded clinical trial. Clinical trial staff members include research coordinators, study coordinators, co-investigators or students.
CGP training is meant to ensure that the rights, safety, and well-being of human subjects are protected and the trial is conducted with rigor and integrity. It is also intended to ensure that investigators are trained in how to collect reliable data.
SJSU provides investigators with access to GCP training through the Collaborative Institutional Training Initiative (CITI). To access the GCP training:
- Visit the CITI website
- Log in, or create an account using your SJSU email address
- Select “San Jose State University Courses”
- Click on “add a course or update learner groups”
- Answer the required questions, and check the box in Question 4, “Good Clinical Practice (GCP)”
Proof of GCP training should be included in the study documentation and must be repeated at least every three years.
ClinicalTrials.gov Registration and Reporting
All clinical trials funded in whole or in part by NIH must be registered at clinicaltrials.gov. You must also submit the results of the trial on the site.
SJSU has an institutional account for clinicaltrials.gov, but you will need an individual user account to register the study. Contact the Research Compliance Unit Mailbox to obtain this user account.
You will need your IRB approval number and a copy of your IRB-approved consent form to register your study - please ensure that your study has been approved by the SJSU IRB prior to requesting your clinicaltrials.gov user account.