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Hello All，
I am working for a hospital‘s clinical trial department， during an IIT clinical trial I found we lost three ICFs， What can I do to report this issue？
[COLOR=#2A2B2E][FONT="]The tricky thing is I can't get in touch with the subject because he's passed away. So how can I certify that subjects have finished ICF before？
Thank you！[/FONT][/COLOR]
In an Investigator Initiated Trial (IIT) the investigator is the sponsor and takes on sponsor responsibilities regarding reporting. Certainly this needs reporting to your Ethics Committee, Your institution, R & D Office, and probably (follow your process) the MHRA (If in the UK). Off the top of my head it would seem that you have three occasions where you have no documentation to show that participants rights have been protected. So that looks like a Serious Breach (look at MHRA guidance) which needs reporting to the MHRA as soon as possible.
[url]https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/905577/Guidance_for_the_Notification_of_Serious_Breaches_of_GCP_or_the_Trial_Protocol_Version_6__08_Jul_2020.pdf[/url]
a123456 already very well explained the reporting aspect. There is one question open, i.e. "[COLOR=#2A2B2E][U][I]So how can I certify that subjects have finished ICF before[/I][/U]".
I am afraid, you could only support a statement that the patients in fact have been consented in time, if there are timely entries in the patient's medical records on the informed consent process. But even this, as said, is supportive. Not a real proof or cretification.[/COLOR]
And remember that there is often the requirement for a "prior" interview in which participants discuss the trial, before the interview in which consent is gained. So it would be prudent to document the time and date of the prior interview as well as the date and time of the consent interview. Useful if this is documented in the participants notes/medical records. As Margit says, this would be useful but not 100% proof that it happened. I would suggest a documented Risk Assessment about the consent process. In this RA you can document the risks that you anticipate (for instance loss of ICF; etc) and what you propose to mitigate that risk. No solution is perfect, but it is good to document this process. Remember that as part of your escalation process for this incident; you should document what the route causes of this event were, and what Corrective and Preventive Action you are proposing to make sure it does not reoccur.