Clinical Trial Informed Consent Forms ("retro-signing")


Sahar Boostenay

Is there any action which might be taken in order not to lose participants who inappropriately signed the ICF? Maybe having the participant sign on a statement stating he/she fully understood the content of the ICF and are willing to allow the trial team use the data collected on them?
To be more specific:
1. Wrote the name in a different language than the ICF is written in.
2. An impartial witness also signed (due to language issues) although the trial specific mentions that no participant should be enlisted if he/she are not able to read and understand the ICF on their own.

The clinical trial is a diagnostic medical device;
1. which exposes the participants only to extremely mild and transient (few minutes) "risk" (skin irritation).
2. the trial procedure takes only about 15 minutes and only one time.

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