Clinical Trials Registration
A Resource For Partners Investigators

WHAT ARE THE REQUIREMENTS FOR CLINICAL TRIALS REGISTRATION?

WHAT IS CLINICALTRIALS.GOV?

WHAT IS FDAAA?    WHAT IS ICMJE?

WHEN IS THE PI RESPONSIBLE FOR CLINICAL TRIALS REGISTRATION?

This website is intended to help Partners HealthCare Investigators understand the requirements for clinical trials registration, their responsibilities for clinical trials registration, and how to register clinical trials on CT.gov.

As of 07/01/11, investigator–initiated clinical trials conducted by Partners investigators that meet FDA Amendments Act (FDAAA) clinical trials registration requirements must be registered on ClinicalTrials.gov prior to IRB approval. For a subset of clinical trials, investigators will also be required to fulfill the FDAAA requirements for reporting results and adverse event on ClinicalTrials.gov at the end of the study.

IMPORTANT NOTE: Even if your investigator-initiated clinical trial does not meet the FDAAA clinical trials registration requirements, you are strongly advised to read the International Committee of Medical Journal Editors (ICMJE) clinical trials registration requirements and consider registering your trial to comply with the ICMJE requirements for publication.

What is ClinicalTrials.gov?

ClinicalTrials.gov is a public database developed by the US National Library of Medicine that offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. Information available on ClinicalTrials.gov includes registration and results reporting information. More information can be found here: http://clinicaltrials.gov/ct2/info/about