Good Clinical Practice Discussion Forum

• International Certification for GCP Auditors

  Ruth Lopez

  Anon (19/08/2019)

  1
• CRA access to EHR

  Ana

  Colin Wilsher (19/08/2019)

  1
• Project contract finalization

  Anon

  Anon (16/08/2019)

  1
• Quality Systems effectiveness verification

  Anon

  Anon (14/08/2019)

  2
• Question regarding the new EMA TMF Guidance

  Anon

  Colin Wilsher (12/08/2019)

  2
• Sponsor SOPs

  MS

  MS (07/08/2019)

  2
• Consent in Retrospective Data Trials

  Emma Damoulakis

  Colin Wilsher (07/08/2019)

  1
• 21 CFR part 11 in Europe

  Eleonora Scorpiniti

  Ruth Lopez (01/08/2019)

  2
• Use of e-signature in a printed TMF

  ANON

  Anon (31/07/2019)

  3
• Consent form

  Katarzyna

  Colin Wilsher (29/07/2019)

  4
• GCP and 3rd EU QA

  Houda OUAHTITA

  Houda OUAHTITA (04/07/2019)

  0
• Note to File to an SOP

  Ana

  Raquel (28/06/2019)

  3
• Application of esignatures at a CRO across different document types

  Anon

  Raquel (28/06/2019)

  3
• EU Regulation 536/2014 repealing Old Directive 2001/20/EC

  Mian

  Mian (23/06/2019)

  0
• Eu guidances

  Anon

  Mian (23/06/2019)

  3
• MHRA - when to notify of change

  LM

  Mian (23/06/2019)

  2
• GCP training

  Mian (23/06/2019)

  2
• Quality Agreement between sponsor & CRO

  Aurelie Fuchs-Wingert

  Mian (23/06/2019)

  3
• EU Regulation number 536/2014 and SUSAR

  Ana

  Mian (23/06/2019)

  4
• Equipment qualification

  Anon

  Colin Wilsher (20/06/2019)

  3

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