Good Clinical Practice Discussion Forum

• Shipping of IMP before BA/BE study approvals

  Colin Wilsher (23/10/2018)

  1
• Supporting client audits

  Supporting client audits (19/10/2018)

  0
• Need Band 7, 8, 8.5 or 9 in Ielts,Or over 60 toefl

  Need Band 7, 8, 8.5 or 9 in Ielts,Or over 60 toefl (18/10/2018)

  0
• Patient transfer

  anon

  M (11/10/2018)

  4
• Patient travel

  anon

  Colin Wilsher (10/10/2018)

  2
• Equipment

  Sabrina Dey

  Sabrina Dey (03/10/2018)

  3
• Archiving Retention Period for Non-CTIMPs

  Anon

  Colin Wilsher (01/10/2018)

  1
• Opt-out approach as 'consent'

  Anon

  Colin Wilsher (28/09/2018)

  1
• Laboratory close down

  Anon

  Colin Wilsher (24/09/2018)

  2
• Adverse Events "Unlikely"

  Diana

  Anon (17/09/2018)

  4
• Expiry date of templates/attachments of SOPs

  Viky

  Colin Wilsher (13/09/2018)

  3
• Certified copies

  Anon

  Colin Wilsher (06/09/2018)

  3
• Scan of paper CRF

  Anon

  Shaun Hastings (06/09/2018)

  2
• Ethical Approval expiry before sample testing commenced

  Anon

  Shaun Hastings (03/09/2018)

  2
• Routine care and protocol deviations

  Anon

  Shaun Hastings (03/09/2018)

  2
• Central Laboratory Documents in ISF

  Jen

  Shaun Hastings (03/09/2018)

  2
• witness required for PRO questionnaires

  Anon

  Shaun Hastings (23/08/2018)

  2
• 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
• System Validation Reports Filed to TMF

  Ferenc

  Ferenc (14/08/2018)

  3

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