Good Clinical Practice Discussion Forum

• Clinical Trial Management System

  MS

  MS (20/09/2017)

  1
• Return of ICF to Sponsor following retention period

  anon

  anon (20/09/2017)

  2
• Risk Management SOP

  Naeem Noordin

  Anon (20/09/2017)

  1
• eTMF requirements for non interventional study

  Anon

  Anon (11/09/2017)

  2
• Vendor Qualification Audit

  Anu

  RQA GLP Committee (08/09/2017)

  2
• Medical Monitors

  KH

  KH (07/09/2017)

  3
• Application of esignatures at a CRO across different document types

  Anon

  Anon (05/09/2017)

  1
• Guidance on risk-based audit of bioanalytical lab

  Anon

  GCP Com (30/08/2017)

  1
• Requirements storage conditions of active period of study/trial

  Suzan de Wit

  Colin Wilsher (29/08/2017)

  1
• Self evident corrections/ Data Management

  Anonymous

  Anonymous (22/08/2017)

  0
• Non Interventional studies

  QA

  GCP Com (22/08/2017)

  1
• Allowed to delegate obtaining informed consent?

  Anon

  GCP Com (17/08/2017)

  1
• Allowed to delegate obtaining informed consent?

  Anon

  GCP Com (17/08/2017)

  1
• PI acknowledgement of Protocol Deviations

  Anon

  GCP Com (04/08/2017)

  1
• Bioequivalence study

  Annu

  GCP Com (04/08/2017)

  1
• MHRA Inspection Report.

  Caroline Chappell

  GCP Com (26/07/2017)

  1
• MHRA Inspection Report.

  Caroline Chappell

  GCP Com (26/07/2017)

  1
• Generic delegation log

  Anon

  GCP Com (21/07/2017)

  1
• Sub-investigator

  Tamara

  GCP com (20/07/2017)

  3
• ICF for intimate areas

  Anon

  GCP Com (14/07/2017)

  1

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