Regulatory ClinicalTrials.gov and FDAAA Frequently Asked Questions

How do I know who the responsible party is for submitting information to ClincialTrials.gov?

If the applicable clinical trial involves an IND/IDE, the IND holder would generally be considered the sponsor and the responsible party under FDAAA. i.e. If DAIDS is the IND holder for a study, DAIDS would be the responsible party.

If the applicable clinical trial does not involve an IND/IDE, the grantee institution would generally be considered the sponsor and the responsible party under FDAAA. The grantee institution has the option to designate the PI of the trial as the responsible party. i.e. If it is a Non-IND DAIDS study, the Network or Organization is the responsible party.

For more information, visit http://grants.nih.gov/ClinicalTrials_fdaaa/Responsible_Party.htm

What is an applicable clinical trial?

For an easy flow chart to determine if your trial is an applicable clinical trial under FDAAA, please visit: http://grants.nih.gov/ClinicalTrials_fdaaa/ACTs_under_FDAAA.htm

For a complete definition and description of “applicable clinical trial”, please see https://clinicaltrials.gov/ct2/manage-recs/fdaaa

 

How do I know whether my trial needs to be registered with ClinicalTrials.gov or whether it needs to be registered AND requires basic results reporting to ClinicalTrials.gov?

FDAAA requires registration and basic results posting of applicable clinical trials.

If your study does not fall under the requirements for an applicable clinical trial, it may still need to be registered to meet journal publication requirements. The International Committee for Medical Journal Editors (ICMJE) requires only registration of interventional trials http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

 

How do I know if my new protocol will require the FDAAA mandated informed consent language?

For trials initiated on or after March 7, 2012, FDAAA requires the mandatory language to be included in informed consents for applicable clinical trials only.

Revisions for existing protocols (e.g. LOAs, Amendments) approved prior to March 7, 2012 do not require the mandatory informed consent language.

For more information on DAIDS implementation of this, please visit: DAIDS Implementation of the New FDA Final Ruling for Mandatory Language Regarding Clinicaltrials.gov for Informed Consents.

Can I modify the FDAAA mandated informed consent language?

No, the language cannot be modified.

Where can I find information on FDAAA?

Content last reviewed on 
February 9, 2018