Good Clinical Practice Guide
Results 1 to 2 of 2

Thread: Subject ID Log

  1. #1
    Forum Member
    Join Date
    Dec 2011
    Posts
    7

    Subject ID Log

    Should identifying information of participants who are screen failures but have signed a consent form and undergone study specific procedures (e.g lab tests, ECGs) be entered on the Subject ID Log?

    Thanks in advance for responses.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Posts
    113
    Only data from subjects, who have signed consent, can be retained in clinical trial documentation. Everything begins with consent and hence the subject allows the investigator to begin trial related screening processes and record trial related data . ICH E6 (R1) allows for both a screening log (8.3.20) and a subject ID log (8.3.21). ICH E6 also tells us why there is a subject ID log:- "allows investigator/institution to reveal identity of any subject". So you would need a confidential log that allowed the identity of subjects to be revealed, if needed. ICH E6 also allows different logs to be combined (8.1) "provided the individual elements are readily available". So you can combine logs for subjects who have consented.

Posting Permissions

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