Good Clinical Practice Discussion Forum

• Delegation of tasks

  Diana

  Diana (13/11/2018)

  0
• EU Legal Representative versus Sponsor Responsibilities

  Vanessa Hyde

  Vanessa Hyde (12/11/2018)

  0
• GCP training in US?

  Anon

  Anon (09/11/2018)

  0
• Unblinding of a study subject in recruitment stage

  Rachel

  Colin Wilsher (06/11/2018)

  3
• IMP documentation after relabelling for site pharmacist

  Anon

  Colin Wilsher (01/11/2018)

  1
• Shipping of IMP before BA/BE study approvals

  Anon

  Colin Wilsher (26/10/2018)

  3
• Equipment

  Sabrina Dey

  Shaun Hastings (26/10/2018)

  4
• Supporting client audits

  Anon

  Anon (26/10/2018)

  2
• Subject Identifiers

  Anon

  Shaun Hastings (26/10/2018)

  2
• Analyze clinical samples in non-GCLP lab

  Marc Cheung

  Colin Wilsher (24/10/2018)

  1
• Patient transfer

  Anon

  M (11/10/2018)

  4
• Patient travel

  Anon

  Colin Wilsher (10/10/2018)

  2
• 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