I have a question about source data and CRFs. I wasn't able to create a thread in the data management section. I work in the R&D department for an NHS trust and we have started sponsoring clinical trials. A few investigators of single-centred trials have come to us with the idea of using the paper CRF as the source data i.e. the first place they write down the information. The consent process and visit schedule would be entered into the subject?s medical notes but the details of the trial specific tests would only be entered on the CRF. The original CRF would be left in the subject?s medical notes at the end of the subject?s participation in the trial and a photocopy taken for the researchers use.

Is this acceptable? I would be really grateful for any advice.