Monday 24 January 2011

Source Documentation for Legally Acceptable Representative

In a trial where Legally Acceptable Representatives (LARs) are being used to obtain consent on behalf of the potential subject, it is important to maintain proper source documentation of the procedure.

To demonstrate that valid consent was obtained, the site should request and keep a copy of legal documentation to support that the LAR indeed is legally acceptable as a representative for this potential subject.

Reagan's 'Trust, But Verify' can here be adapted to 'Trust, Verify and Document'. Informed consent is too important a topic to take lightly, and consent by LAR without documentation of the legality of the representative is inadequate consent.wow gold

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