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Thread: Patient consented but not randomized - paperwork

  1. #1
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    Patient consented but not randomized - paperwork

    Hi,

    We have several patients who have consented but subsequently did not get randomized and hence enter the trial. What shall we do with their paperwork? Consent forms etc?

    Many thanks

  2. #2
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    Keep them in the TMF and noted in the subjects notes that they consented to the trial. The subjects did consent to be in the trial and hence are part of the trial. The MHRA might inspect the trial and will ask to see all records of those who consented. Subjects consent not only to be in the trial, but also to you retaining their trial related documentation and to direct access to those documents by monitors, auditors and inspectors. You may have also done some pre-screening and screening on these subjects and this should also be retained for the full period required by UK law if your trial is in the UK. Buy a copy of the MHRA GCP Guide (2012)

  3. #3
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    If a subject consents, but is ultimately determined a screen failure, should their subsequent medical records be accessible to the Sponsor? How does the Sponsor confirm an appropriate consent process without access to the source for that visit? But without infringing on the subjects confidentiality rights, with access to subsequent medical records.

  4. #4
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    This seems to be a different topic to the ones discussed below. It would be good to give this another Discussion Thread.

    I don’t understand.
    The subject has consented so the sponsor and their representatives (& Monitors, auditors, inspectors) are given permission to look at their files. As the subject is a screen failure all subsequent data is not trial related and does not fall under the clinical trial consent permission granted by the subject. With paper records it is the duty of the investigator site staff to make sure that only pertinent records, that the subjects has given consent, are revealed to the sponsor. With EHR something similar could be envisioned. The MHRA takes a Risk Based approach to access to medical records. In the recent MHRA & FDA Symposium, the MHRA said that they encourage sponsor representatives to have direct access to subjects Electronic Heath Records (EHR). A Q & A on this very GCP Forum also tells you what the ICO and Inspectors think might be a useful way forward :-- “The MHRA GCP inspectorate queried the access to Trust electronic health record systems, which do not limit access to monitors with the Information Commissioner's Office (ICO). The ICO responded that the onus is on the Trust to demonstrate that the monitor has only accessed those records permitted (e.g. patients which have provided consent for the monitor(s) to access their source records). Therefore, there should be an agreement in place between the Trust and Monitor(s) to ensure only trial participant's records will be accessed for which consent has been obtained, the access should be read only and the system should have an audit trail. The audit trail should then be checked by the Trust to ensure that the monitor is only accessing those records which they have permission for, thereby verifying compliance with the terms of the access agreement.”

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