Good Clinical Practice Discussion Forum

• Use of EMR in studies - Access to CRA and Auditor - Certified Copies - Blinded Access

  Anon

  GCP Com (18/08/2018)

  2
• Impact of GDPR

  Piran Sucindran

  Shaun Hastings (16/08/2018)

  26
• witness required for PRO questionnaires

  Anon

  Colin Wilsher (16/08/2018)

  1
• System Validation Reports Filed to TMF

  Ferenc

  Ferenc (14/08/2018)

  3
• Filing of e-mail correspondence

  Anon

  Shaun Hastings (13/08/2018)

  8
• SOP effective dates

  Anonymous

  Anonymous (19/07/2018)

  3
• Requirement for original wet ink signatures on Document Control Records

  Anon

  Bert (03/07/2018)

  8
• Trace the Freezer Temperature through Wireless System

  Harold

  RQA GLP Committee (03/07/2018)

  4
• SOP updates

  Anon

  Anon (27/06/2018)

  4
• Electronic Signatures

  Bert

  Shaun Hastings (21/06/2018)

  2
• re-consent of healthy subject in a phase I study

  elisa lorenzi

  Colin Wilsher (19/06/2018)

  1
• Consent for secondary use of study data

  anon

  Shaun Hastings (12/06/2018)

  6
• Collection personal data site staff

  bert

  Shaun Hastings (12/06/2018)

  5
• Does an LMS need to be 21 CFR Part 11 compliant

  Michael

  Matt Jones - Chair, DIGIT Committee (03/06/2018)

  1
• Inspection Dossier and Computer Systems

  JP

  Colin Wilsher (28/05/2018)

  3
• Essential documents and retention times for a Central Laboratory

  Gill

  Colin Wilsher (25/05/2018)

  1
• eTMF requirements for non interventional study

  Anon

  Colin Wilsher (24/05/2018)

  4
• MHRA request draft protocol

  christy

  Christy (08/05/2018)

  2
• Grading of findings

  Anu

  RQA GLP Committee (04/05/2018)

  4
• Minimum Sponsor oversight/responsibilities virtual company

  Anon

  Jane Self (04/05/2018)

  4

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