Good Clinical Practice Guide
Results 1 to 4 of 4

Thread: Informed Consent Forms stored in ISF

Hybrid View

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

    Informed Consent Forms stored in ISF

    Hi All,

    I just have a quick query for you all which i hope you can help with.

    If a site stores the original wet-ink ICF for a patient in their medical notes, and only stores a copy in the ISF, is it required that the copy be redacted?

    Many Thanks,
    Steve

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Posts
    141
    I assume that the ISF is the Investigator Site File and is under the control of the investigator? Why would redaction be necessary? You are not releasing the consent forms to outside of the investigator site. Obviously I must have misunderstood.

  3. #3
    Quote Originally Posted by a123456 View Post
    I assume that the ISF is the Investigator Site File and is under the control of the investigator? Why would redaction be necessary? You are not releasing the consent forms to outside of the investigator site. Obviously I must have misunderstood.
    Hi a123456,

    Yes, i did mean Investigator Site File, which is stored at site under control of the investigator.

    We were advised that the consent forms would need to be redacted (in preparation for potential inspection) as this must be done 'by law'. This is not something that we have heard of before so i thought i would ask to see if this was the case (new legislation for example). The consent forms would expected to be checked, but would not be removed by inspectors either as far as i am aware.

    Sorry for not being clear.

  4. #4
    Forum Member
    Join Date
    Nov 2011
    Posts
    141
    most consent forms i have seen have the subject explicitly consenting to the monitor, auditor and inspector having direct access to the original signed consent forms and medical records. look at your consent forms.

Posting Permissions

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