Sponsor is the best of the answers given but note that the PI could be held responsible depending on the circumstances (which is why it’s a good thing in industry-sponsored agreements to assure that the industry sponsor explicitly assumes responsibility for trial registration).  NIH generally views the PI on a grant as the responsible party.

FDAAA defines the “responsible party” as follows:

‘‘(ix) RESPONSIBLE PARTY.—The term ‘responsible

party’, with respect to a clinical trial of a drug or

device, means—

‘‘(I) the sponsor of the clinical trial (as defined

in section 50.3 of title 21, Code of Federal Regulations

(or any successor regulation)); or

‘‘(II) 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.”

NIH has developed a nice flowchart to help determine who is the responsible party: http://grants.nih.gov/Clinicaltrials_fdaaa/docs/registration_flow_chart_narrative.doc

Rachel Nosowsky

Principal Counsel

University of California

(510) 987-9407

xxxxxx@ucop.edu

Visit us at http://www.ucop.edu/ogc 

To all

During my CRA studying adventure this is my exposing discovery

Which of the following is responsible for clinical trial registration on CliniicalTrials.gov?

My research resulted in the Sponsor: The entity responsible for registering is the “Responsible Party.”

NIH Notice: NOT-OD-08-014 Guidance on Public Law 110-85, enacted to expand the scope of clinicalTrail.gov

Sponsor of Clinical Trail is responsible for registration (21 CFR 50.3)

Please provide feedback J

Art Thomas

Unit Research Administrator

Department of Psychology – USF

4202 E. Fowler Ave, PCD4118G

Tampa, FL 33620

Voice: (813) 974-0359, fax: (813) 974-4617

xxxxxx@usf.edu

Hello, we have 9 people from our office getting ready to take the CRA exam. 

There is a question on the CRA practice test that I was hoping you could clarify for us….

The question is who is responsible for registering a clinical trial at clinicaltrials.gov.  The website says "responsible party" (i.e., the sponsor or designated principal investigator) register and report results of certain "applicable clinical trials".  The list of answers include the sponsor, institution, OSP, and IRB.  We were torn between the sponsor and the institution. 

Some think it is the sponsor since PI is not listed.  But some think the answer is the institution (essentially the PI on behalf of the institution).  Can you help?

Sincerely,

Vicky Ratcliffe, MBA
Manager of Research Education and Development
Office of the Vice President for Research
Virginia Tech
301 Burruss Hall
Blacksburg, VA 24061
Mail Code 0244
540-231-7964 Office
xxxxxx@vt.edu

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