Good Clinical Practice Discussion Forum

• Impact of GDPR

  Piran Sucindran

  Shaun Hastings (21/06/2018)

  24
• SOP updates

  Anon

  Shaun Hastings (21/06/2018)

  3
• 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
• Trace the Freezer Temperature through Wireless System

  Harold

  Colin Wilsher (18/06/2018)

  3
• 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
• New Laboratory Information System

  Anon

  RQA GLP Committee (30/04/2018)

  1
• Efficient, usable SOPs

  Simon Kerridge

  Maxim Bunimovich (27/04/2018)

  2
• Certified Copies - Faxes/Scanned Documents from Secondary Facilities

  Eleanor

  karolj (26/04/2018)

  3
• Dataloggers in sample shipments

  Jordi

  Jordi (11/04/2018)

  4
• Supply of vaccine to investigator sites

  Anon

  D. Chesnais (09/04/2018)

  1
• Declaration of Helsinki version

  JLL

  D. Chesnais (06/04/2018)

  7

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