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Thread: Screening Log & Identifiable information

  1. #1

    Screening Log & Identifiable information

    Hello, does anyone have any direct experience of how much information you can collect on a screening log ? I understand ICH E6(R1) 8.3.20 says we can keep a Subject Screening Log to document identification of subjects who entered pre-trial screening. On the majority of trials I have worked on they ask for patient initials and then basic information regarding eligibility and whether or not the patient went on to become enrolled.

    I am receiving instruction from one particular Sponsor that we must remove the patient initials as this constitutes patient identifiable information (PII), in a pool of 300 screened patients with no other information (simply initials alongside eligible yes/no). Does this sound reasonable? Without the initials the screening log wouldn't make much sense or allow us to loosely track and avoid screening a patient more than once.

    Thanks

  2. #2
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    I don’t think I understand the question. Screening log only includes any subject who has given consent (obviously consent is gained before any screening activities) because the researchers can only record and retain any study related data on subjects who have consented to this. This means that the research site is perfectly entitled to retain data which might indirectly identify the subjects (such as the subject initials). However information sent to the Sponsor should have any identification information removed (including initials). This means that the site will have the initials and the sponsor will not. Also the site has the subject ID log 8.3.21 which will always identify those who have given consent and hence the site would not screen the same subject twice. The MHRA GCP Guide (2012) 11.4.1 as useful information on screening and what can be done before consent (pre-screening) “no trial specific screening activities..until informed consent to participate in the trial is obtained from the subject” . The Research Quality Association (www.theRQA.com) also has interesting Q & As on what constitutes pre-screening.

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