How Do You Register a Clinical Trial in the US?

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How Do You Register a Clinical Trial in the US?

Clinical Trail Registration Process In the US

In the US clinical trials are registered in clinical trial.gov which is a publicly available database, this is an online database managed by the National Library of Medicine (NLM), In this database we can get information about the clinical trials conducted around the globe.

Who is responsible for registration: Generally, the sponsor is responsible for the registration of clinical trials unless he assigns the principal investigator as a responsible person.

Criteria for clinical trial registration: Here let us understand first the final rule (42 CFR Part 11) Food and Drug Administration Amendments Act of 2007 (FDAAA) according to this the following studies can be registered – interventional studies, FDA-regulated products like drugs, biological or device products other than phase 1 trials of drug /biological products.

Clinical trials for which registration is not required – noninterventional studies, phase-1 studies, non – FDA regulated products.

Note: Even though the registration of Phase-1 trials is not mandatory, researchers are encouraged to voluntarily register to enhance clinical trial transparency, to meet the requirements of funding bodies etc.

For registering your clinical trials at clinicaltrial.gov, first you need to consider the regulatory requirements, then access whether you trial need to be registered by reading the above requirements mentioned, then if required create an account in the clinical trial . gov and enter the study details like requirements of participants, study protocol etc. and submit your registration.

Sponsor has to submit required clinical trial information within 21 days from the enrollment of first participant and results should be submitted after study completion. here study completion date would be the last subject examined in study.

The results submission date will be 12 months from the primary completion date , sometimes extension can be requested from FDA if there is a delay in results submission due to unforeseen circumstances.

 

 

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