NIH Enhanced Checks for Compliance with Clinical Trial Registration In Effect October 1, 2021.
Enhanced Checks on Non-Compliance with Clincial Trial Registration Information
What is a 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 interventions on health-related biomedical or behavioral outcomes. Interventions include drugs, medical devices, procedures, vaccines, as well as noninvasive approaches such as surveys, education, and interviews.
Why register my clinical trial?
It became a requirement to register all National Institute of Health (NIH) funded clinical trials as of 2007. Even noninvasive approaches may be required to register at clinical trials. See FR 42.CFR part 11.
Even studies not funded by NIH are required by publishers to register high impact journal clinical trials.
Who is required to register?
Clinical trials testing drugs and devices are required by federal regulations to register their clinical trial on ClinicalTrials.gov; many other clinical trials are now being required by funders and publishers to also register their study.
Federal regulations 42CFR11 requires all clinical trials testing applicable devices or drugs to register their study on ClinicalTrials.gov prior to beginning recruitment. However, it is becoming more common for all clinical trials, either biomedical or behavioral, to register first on ClinicalTrials.gov. The NIH requires all clinical trials they fund to register, and leading journals are requiring clinical trials to be registered prior to the study beginning as a condition for publication.
Before applying for a Protocol Registration and Results System account on ClinicalTrials.gov, you should make sure you're the appropriate person to submit clinical study information. Studies subject to the regulations are registered only by the Responsible Party, although other users can be authorized to add information to the study record either before or after a study is registered.
Am I the responsible party to register the clinical trial?
Each study has one Responsible Party. That responsible party can be either a sponsor, a principal investigator, or a sponsor-investigator.
Sponsor: The entity (for example, corporation or agency) that initiates the study
Principal Investigator: The individual designated as responsible party by the sponsor (see Note)
Sponsor-Investigator: The individual who both initiates and conducts the study
Note: The sponsor may designate a principal investigator as the responsible party if such principal investigator meets all of the following requirements: is responsible for conducting the study; has access to and control over the data from the study; has the right to publish the results of the study; and has the ability to meet all of the requirements for submitting and updating clinical study information.
For further information regarding how ‘Responsible Party’ is defined, use the following link: https://prsinfo.clinicaltrials.gov/definitions.html.
When do I need to register?
Before the study’s Overall Recruitment Status changes to Recruiting. Studies can be registered prior to IRB approval; once IRB approval is obtained, update the study record on ClinicalTrials.gov and submit the study for processing. There are different deadlines for different categories of clinical trials, but the SDSU IRB recommends registering a study as soon as possible to avoid becoming noncompliant and not meeting conditions for publication.
Where do I go to register?
Where can I find more support?
https://www.clinicaltrials.gov/ct2/manage-recs/resources
The linked webpage above includes checklists, user’s guides, review criteria and major comments lists, as well as key U.S. regulations, policies, and international policies.