Good Clinical Practice Discussion Forum

• Clinical Trial Dedicated Website

  Steve

  Steve (04/08/2020)

  7
• AE reporting - state after hospitalization

  Anon

  Dominique Chesnais (29/07/2020)

  2
• Best practice for validation of statistical analysis

  Anon

  Colin Wilsher (28/07/2020)

  3
• IP release and CP certification/training of PI

  Laurence Trinquard

  Dominique Chesnais (28/07/2020)

  2
• EU : Review/Sign eCRF

  Dominique Chesnais

  Dominique Chesnais (28/07/2020)

  0
• IATA requirements in the EU

  Neeru

  Dominique Chesnais (23/07/2020)

  2
• UK MHRA GCLP Laboratory Facility Certification

  Aldwin Aldana

  Colin Wilsher (23/07/2020)

  1
• Investigator Initiated Studies

  Anon

  Anon (22/07/2020)

  5
• non interventional study

  Anon

  Colin Wilsher (21/07/2020)

  1
• Guidance on the collection of female partner pregnancy information

  Anon

  Colin Wilsher (17/07/2020)

  7
• Storage limits with paper documents in ISFs

  Kerry Bunyan

  Colin Wilsher (13/07/2020)

  1
• Collection personal data site staff

  bert

  Colin Wilsher (08/07/2020)

  9
• DGPR in FRance

  Tim Stiles

  Tim Stiles (03/07/2020)

  5
• Quality Assurance vs Compliance roles

  Anon

  Dominique Chesnais (02/07/2020)

  2
• Validation of a Scanning Process (Cert. Copy)

  Anon

  Colin Wilsher (02/07/2020)

  2
• Audit trail review

  Anon

  Dominique Chesnais (01/07/2020)

  4
• Documenting time in source documents and medical records

  Anon

  Dominique Chesnais (01/07/2020)

  6
• who will sign ICF first, subject or investigator, ICF designed date and time, ICF is signed in the same date and different time point.

  water

  Dominique Chesnais (01/07/2020)

  3
• Calibration certificate of data logger

  Diana

  Dominique Chesnais (01/07/2020)

  6
• Performing remote SDV on EU subjects from within the UK?

  Christine Henderson

  Dominique Chesnais (01/07/2020)

  6

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