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We have a patient transferring to an active site in a different trust (Moving from paediatric consultant to adult). Once this patient transfers, the site will close, as there will be no remaining patients participating.
The Sponsor SOP requires copying of all relevant documentation, but who should keep the originals - does the patient binder with original consents and visit worksheets get packed up and sent to the new site? Or do copies of all relevant documents get sent on to the new site?
Just guessing, but won't the site that originates documentation need to keep all originals (& certified copies) under their "Control" and in their site TMF to comply with GCP guidelines and legislation? They will also need all those originals (& certified copies) for audits and inspections at any time in the future.
The second site will need copies of the first sites records that are essential to the good management of the patient and the good management of the study. Good idea to look at the EMA final guidance on TMF where they say where originals, certified copies and copies will be required. The MHRA were at that time part of EU and were the major movers regarding TMF guidance.
[url]https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-archiving-clinical-trial-master-file-paper/electronic_en.pdf[/url]