Bioequivalence and Bioavailability Forum

Dear All,

Please guide me on the above issue. Is it necessary to take signatures on the photocopy of source document for documentation purpose? (as we require to share few forms (from CRF)/documents with another department of CRO).

e.g.
1. We are sharing sampling time point deviation form with Biostatistician. In clinical department we are maintaining original copy and photocopy will be shared by statistical department. As per our current practice this photocopy is not certified (attested) by clinical department.

According to ICH GCP E6 guidelines. section 1 Glossary;
1.51 Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

Now my question is, Do we need to take signatures on the photocopy of Sampling time point deviations intended for stat documentation process?

Warm Regards,
Preet