Regulatory Open Forum

 View Only

  • 1.  CTA or Contract for clinical trial sites

    This message was posted by a user wishing to remain anonymous
    Posted 23-Apr-2020 16:59
    This message was posted by a user wishing to remain anonymous

    For a 510(k) submission does the FDA consider a Clinical Trial Agreement (CTA) to be adequate as a Contract?  I have been involved in studies where both are required by the site and others that only require the CTA.


  • 2.  RE: CTA or Contract for clinical trial sites

    Posted 24-Apr-2020 04:26
    Hello,

    From a device standpoint, especially if the study is for a non-significant risk device, the CTA should be adequate.  I have performed clinical studies in the past only using the CTA which has the clinical, roles, responsibilities, reporting, etc., which is signed by the Sponsor and the Site - this has not been questioned.  Anyway, most of the time for 510(k) submissions you are including the clinical study protocol and clinical study report.  All the other documentation should comply with GCP and may only be reviewed during a BIMO or regular site inspection.  But yes, if the site requires both this is not really a regulatory requirement but a business/legal requirement from either party.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: CTA or Contract for clinical trial sites

    Posted 24-Apr-2020 08:29

     

     

    I agree with Richard; a contract between sponsor and site is virtually always scoped for business and legal matters.  FDA has authority over the investigator responsibilities described in 21 CFR 812/312, but assigning these is the purpose of the CTA.  In contradistinction, FDA does not have authority over the business clinical study site contracting.  This assertion would not hold up if a contract was written to include any of the 812/312 responsibilities, but in decades of running clinical studies I have never seen that done.

     

    I suppose FDA *would* have authority over a contract, if it were executed directly with an individual physician--at least to the extent the terms might play into financial disclosure requirements under 21 CFR 54.  This is one reason why the contracts are usually with an institution or some other business entity.

     

    MED Institute has run hundreds of clinical studies for our clients in well over 30 years of our existence, and supported quite a number of BIMO inspections-all successful.  In that time, I don't recall FDA (reviewers or investigators) ever asking to see business contracts between the sponsor and site.

     

    Hope that is helpful,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     

     

     




    Original Message


  • 4.  RE: CTA or Contract for clinical trial sites

    Posted 24-Apr-2020 08:24
    My thinking is that the CTA is required by the FDA to document the investigator's agreement to conduct the clinical trial according to regulations, while the site my require a contract for other reasons, such as financial terms for conducting the study, indemnification, etc. Depending on whether the investigator is getting paid for performing the study and the device risk, financial arrangements and indemnification may not be required.

    ------------------------------
    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
    ------------------------------

    Original Message


Related Content