ClinicalTrials.gov

By Matthew Nemelka | August 4, 2016 |

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.

For more information, please contact these members of Partners QI — Sarah White (swhite12@partners.org), Emily Ouellette (eouellette@partners.org), or Jennifer Ballard (jpballard@partners.org). You may also contact Kele Piper, MGH Research Compliance

The MGH/MGPO confidential and anonymous Compliance Helpline: 617-726-1446