Hi
I was interested to hear if anyone had come across a situation where the medical notes of a trial patient have been lost at the investigator site? What would you advise in terms of actions for this? A copy of the conset form, completed CRF, and lab results are available in other formats but the notes that recorded the visits and eligibility verifications are missing.
Many thanks,
Praseeda
Secure maintenance of source documents is a prime requirement of GCP. Therefore it would be advisable to check your institution's SOP on escalation process for deviations of GCP. This will include documented consideration as to whether this is a Serious Breach of GCP and whether it needs reporting to the MHRA. Do we know why the source documentation is missing? Was the CRF monitored? If so then at least there will be documentation about the check of that data against the source.
The Research Quality Association (www.theRQA.com) GCP Committee gave an answer to a similar question on 22May2010. This might be of interest to you.
Answer from GCP Committee:- The extent of corrective and preventive measures would depend on whether this was/could be a recurring problem or a genuinely isolated incident – this requires some investigation by the site into this case and its procedures for handling all medical records. If it were not isolated or might conceivably happen again, then procedures at the site should be revised and (re)training of staff performed. The investigator should write an explanatory filenote setting out what happened, what is and is not available and what will be done to reduce the chance of it happening again.
It would also be appropriate for them to address the issue of subject data protection, in terms of notifying the subject and following any other aspect of data protection process that the site has, including documentation of steps taken. It is likely this would also include notification to the Sponsor, the IEC, the host institution (incl. R&D office if in the UK) and the data privacy officer.
In addition, possibilities should be explored to recover some/all of the lost documents from elsewhere: e.g. obtaining copies/certified copies of key source documents from electronic records, originating departments or other referring physicians. How to make certified copies is covered in the GCP Committee Q&A Database (#KM07).
And finally, whether any department appointment diary or dispensing records might at least show attendance on study visit dates should be considered.
Posting Permissions
Reply With Quote