Good Clinical Practice Discussion Forum

• Creating a QMS from the ground up

  Hannah

  Colin Wilsher (15/02/2019)

  3
• Use of SharePoint for eTMF?

  Jane Self

  Jane Self (14/02/2019)

  3
• Essential documents for study that was set up but never activated

  Anon

  anon (14/02/2019)

  6
• Sponsor Auditor

  Kumar

  Ravi Shah (13/02/2019)

  6
• Site staff CVs

  Karen

  fatima rajab mishmish (12/02/2019)

  4
• US Multi Centre Study - No Coordinating Investigator

  Vanessa Hyde

  Colin Wilsher (08/02/2019)

  1
• Archiving issue - an observation in the audit report or not?

  Anon

  Margit Zehrer (05/02/2019)

  2
• QAs tasks in Validation of analytical methods

  Anonym

  Anon (01/02/2019)

  1
• (e)CRF archiving on site - copies of site data on CD/DVD

  Anon

  Colin Wilsher (29/01/2019)

  1
• ICH E6 R2 Certified copies - applicability

  Anon

  Young Eun Kim (25/01/2019)

  6
• Use of clinical samples

  Anon

  Anon (24/01/2019)

  6
• Site Referrals

  Anon

  Colin Wilsher (23/01/2019)

  3
• Source documents for CT examinations

  Anon

  Henrieke (21/01/2019)

  3
• Country specific protocol

  Mihaela nosca

  Mihaela Nosca (21/01/2019)

  2
• Electronic 'shadow' TMF

  Anon

  Anon (07/01/2019)

  1
• Audits and CAPA

  Anu

  Anon (07/01/2019)

  2
• ISR sample selection

  Anitha

  Ajay Bosamiya (25/12/2018)

  2
• Clinical Trial Management System

  MS

  Ajay Bosamiya (25/12/2018)

  9
• Brexit

  Sabrina

  Sabrina (18/12/2018)

  3
• GDPR and patient confidentiality breaches

  carole jenkins

  Colin Wilsher (12/12/2018)

  1

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