Good Clinical Practice Discussion Forum

• EDC Audit Discovery

  Anon

  Colin Wilsher (22/09/2021)

  3
• Can QA also be the DPO?

  Nikki Cooper

  Colin Wilsher (22/09/2021)

  3
• Clinical Study Report

  Jane

  Colin Wilsher (22/09/2021)

  1
• pre-screenning log

  Anne

  Colin Wilsher (21/09/2021)

  2
• Planned SOP deviation

  Anon

  Colin Wilsher (18/09/2021)

  4
• Delegation of authority to regulatory staff

  Ana Villarreal

  Ana Villarreal (09/09/2021)

  4
• Sign-off of eCRF by Investigator (frequency and timing)

  Anon

  Colin Wilsher (08/09/2021)

  1
• URS of LMS and LCMS

  Nayan Prajapati

  Anand Pandya (07/09/2021)

  5
• CTR

  Rohini Wandekar

  Colin Wilsher (06/09/2021)

  1
• Regulatory Guideline of Serious Breaches before the final implementation of EMA 31 January 20171 EMA/430909/2016 (draft)

  Ruth Lopez

  Ruth Lopez Magdaleno (01/09/2021)

  2
• Collection personal data site staff

  bert

  Colin Wilsher (27/08/2021)

  12
• E-consent

  E Chong

  Dominique Chesnais (17/08/2021)

  6
• Clinical Quality Agreement

  Mar

  Anon (09/08/2021)

  12
• Germany: Review/Sign eCRF

  Anon

  Colin Wilsher (05/08/2021)

  24
• E-Archiving

  Kate Rolfvondenbaumen

  Dominique Chesnais (04/08/2021)

  3
• Pharma / Biotech GCP SOP list for all function

  Mariem

  Dominique Chesnais (04/08/2021)

  4
• Archiving CRF Copies at Investigator Site

  Vanessa Hyde

  Vanessa Hyde (02/08/2021)

  4
• Investigator Brochure

  Deborah Fox

  Deborah Fox (30/07/2021)

  2
• Remote pharmacovigilance inspections of MAHs

  Dominique Chesnais

  Colin Wilsher (28/07/2021)

  3
• Business Continuity SOP

  Tom J

  Andi Duferense (27/07/2021)

  4

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