Who is responsible for registering trials on ClinicalTrials.gov?

RESPONSIBLE PARTY

Is the term used in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA)(PL 110-85) to refer to the entity or individual who is responsible for registering a clinical investigation and submitting Clinical Trial Information to the Clinical Trial Registry Data Bank. The statute defines the term as follows:

 

  • (1) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation); or

 

  • (2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.”

 

Further Information:

21 CFR Part 50

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.3

 

Elaboration of Definitions of Responsible Party and Applicable Clinical Trial

http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf

 

FDAAA 801 Requirements (ClinicalTrials.gov Website)

http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhoIsResponsibleForRegistering

Responsible Party Data Element

http://prsinfo.clinicaltrials.gov/definitions.html#RespParty

 

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