Good Clinical Practice Guide
Results 1 to 3 of 3

Thread: Same person acting as both sponsor AND site staff - inappropriate?

Hybrid View

Previous Post Previous Post   Next Post Next Post
  1. #1

    Same person acting as both sponsor AND site staff - inappropriate?

    Hi all,

    I would appreciate your thoughts and experience on having the same person acting as TM for sponsor and TC for site (and potentially entering data too)? This means being on both site and sponsoir delegation log.
    It doesn't seem appropriate in my eyes having access to both trial management and patient identifiable data....but this is the way our organisation is moving. We are mainly CTIMPS.
    I understand staff resources are a factor, but I would have thought it is a practice to be discouraged, especially for CTIMPS.

    I have asked our GCP team but there are being non commital, presumably as there are no specific regulations regarding this.

    Thank you,
    TrialsAdvice

  2. #2
    Hi there,

    Is there no one out there that would be happy to advise on my above query?

    Thank you,
    TrialsAdvice

  3. #3
    Forum Member
    Join Date
    Nov 2011
    Posts
    167
    I wonder if a Risk Assessment of this situation might be appropriate?
    Certainly it is less than desirable for the sponsor and clinical trial staff to be the same people. There are inherent conflicts of interest and a failure to insure that the roles of investigator and sponsor are fulfilled as per ICH E6 R2.
    How will the duties of investigator and sponsor be efficiently conducted in compliance with GCP and regulations??
    For instance the sponsor is responsible for selecting the investigator (5.6.1) how is this achieved without conflict of interest?
    The sponsor is responsible for selecting, appointing and directing monitors whose duties include verifying that the investigator follows the protocol etc, etc, how is this achieved without conflict of interest? (5.18)
    The sponsor is responsible for taking prompt action to secure compliance by the investigator/institution (5.2), how is this achieved without conflict of interest?
    Investigators have a responsibility to oversee (4.2.5 & 6) any individual or party to whom they delegate trial related duties, how is this achieved without conflict of interest?
    There are lots more examples of investigator and sponsor duties.

    If your documented Risk Assessment (RA) can adequately show how GCP & regulations are adequately complied with, without any conflict of interest, then it might be possible to use a system such as you describe. Probably best to check to see if your Ethics Committee and the Regulators (Inspectors) agree with your RA.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •