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18th Feb 2020, 08:08 PM
#3
Interesting that after 10 years after death medical records are destroyed. As current GCP legislation requires 15 years retention (in the case of PLA trials) and in future it will be 25 years, it may be wise the plan ahead.
Your Risk Assessment might show that for many trials there is a little risk to the data integrity of a small amount of data that may only be stored for 10 years after a subjects death. However for high mortality trials and/or trials where death is an outcome, there may be a very high risk. In this case serious consideration should be made to requiring (perhaps through contractual arrangements) the investigator/institution to apply and retain in the TMF/ISF, certified copies of the relevant parts of the medical records before destruction.
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