MHRA wants to see paper records retained

MHRA commented in their discussion forum on retention of trial records

MHRA modifies its position on destruction of paper from that offered by the MHRA GCP Guide (2012): “The use of an eTMF would be considered as a prerequisite to the sponsor’s being able to destroy paper records and reduce storage requirements. ...transfer of the document to an eTMF repository could enable earlier destruction of the paper original. ...early, complete destruction of such records is not currently recommended or should only be undertaken on a risk-adapted approach. The current recommendation is to undertake a risk assessment in order to decide which documents do not need to be retained on paper, particularly focusing on whether the paper version could be obtained or not upon request (e.g. reprinted or from another location).”

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