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Guideline on the content, management and archiving of …
06 December 2018. EMA/INS/GCP/856758/2018. good clinical Practice Inspectors Working Group (GCP IWG). Guideline on the content , management and archiving of the clinical trial master file (paper and/or electronic). Draft adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2017. Start of public consultation 12 April 2017. End of consultation (deadline for comments) 11 July 2017. Final revised document after comments received from public consultation 06 December 2018. adopted by GCP Inspectors Working Group (GCP IWG). Date of coming into effect 6 months after publication Keywords Trial master file, TMF, eTMF, essential documents, GCP inspection, archiving , scanning, retention, destruction 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555.
Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) Draft adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2017 Start of public consultation 12 April 2017 End of consultation (deadline for comments) 11 July 2017
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