Designation of Responsible Party

NOTE: If your study meets the FDAAA registration reporting requirements – you MUST complete the designation of Responsible Party letter.

If registration of your trial is to meet ICMJE requirements, you DO NOT need to complete a designation letter.

Who Is The Reponsible Party?

The FDA Amendments Act of 2007 (FDAAA) defines the Responsible Party as:

• The IND/IDE holder, OR
• If no IND/IDE:
  • The industry, cooperative group, consortium or other external sponsor that initiated the study, OR
  • If initiated by a Principal Investigator
    • The grantee institution (e.g. MGH/BWH), OR
    • If no external funding, the PI

Elaboration of Definitions of Responsible Party and Applicable Clinical Trial

Can A Grantee Institution Delegate The Responsibilities Of The Responsible Party?

Yes, to an individual who:

• Is responsible for conducting the study
• Has access to and control over the data
• Has the right to publish the trial results, AND
• Has the ability to meet the requirements

What Is The Partners Process?   What Do Principal Investigators (PIs) Need To Do?

As of July 1, 2011:
PIs of studies with MGH/BHW/FH as the grantee institution that meets the FDAAA clinical trials registration requirements must sign the Registration Designation Letter acknowledging their responsibilities for registering the clinical trial on ClinicalTrials.gov and for updating the registration as required by FDAAA (see link below).

PIs of studies with MGH/BHW/FH as the grantee institution that meet the FDAAA clinical trials registration and reporting of results requirements must sign the Registration And Reporting Designation Letter acknowledging their responsibilities for registering the clinical trial on ClinicalTrials.gov and for reporting results.

A designation letter signed by the PI will be required for IRB approval. The letter should be downloaded to your computer, signed, scanned and uploaded as an attachment in the Insight/eIRB submission. The original signed copy should be retained for your files.

Registration Designation Letter (editable pdf)
This letter is required if your study meets FDAAA registration requirements.

Registration And Reporting Designation Letter (editable pdf)
This letter is required if your study meets FDAAA registration AND reporting requirements.