Good Clinical Practice Guide
Results 1 to 2 of 2

Thread: Patient identifiable data and Archiving ISF

  1. #1
    Forum Member
    Join Date
    May 2023

    Patient identifiable data and Archiving ISF

    We are being asked to ensure that any participant identifiable information be archived separately from pseudo anonymised /case report forms (CRF) data by placing the information in a clearly marked sealed envelope.

    I understand that we don't need to redact patient identifiable information as secure archiving fulfills confidentiality required by GDPR and Clinical Trial regulations. Does the same principle not apply and we shouldn't be required to separate patient identifiable information from CRFs. If correct can anyone provide back up information to support this as it seems a lot of work to separate documents if not required.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Sorry I don't have an answer for you, hopefully someone with either GDPR or regulatory expertise will reply.
    Is the reason why they are asking for separation of personal identification Information (PII) is that when the retention time is reached or when the retention of PII is no longer necessary (under the terms of retention as per GDPR), that this PII data will be destroyed because there is no longer a GDPR reason for retention? Separating or flagging PII data, will make it more efficient to find and remove when the time comes.

    It could also be that they want to make sure that PII data is fully respected with regard to compliance with legal data protection requirements, when other data may not have such exacting requirements. That would assume that there was more than one standard for care or data in the archive and usually there is just one standard applied across all data/records as this is usually easier to implement and police.

    I hope you get an answer

Posting Permissions

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