Good Clinical Practice Discussion Forum

• Archiving International Trials

  Anon

  Anon (16/04/2021)

  3
• Certified copies

  Anon

  Dominique Chesnais (15/04/2021)

  2
• IWRS for site IP accountability

  Gladys

  Margit Zehrer (30/03/2021)

  10
• GCP certification in CV

  Gladis

  Colin Wilsher (27/03/2021)

  8
• SUSARs notification to Principal Investigators

  Ana

  Marko (25/03/2021)

  11
• GCLP accreditation/certification

  Julie Cameron

  Anon (25/03/2021)

  1
• Business Continuity SOP

  Tom J

  Dominique Chesnais (25/03/2021)

  2
• Informed Consent

  Ioanna

  Colin Wilsher (24/03/2021)

  8
• MHRA UK risk-based GxP inspection programme

  Dominique Chesnais

  Dominique Chesnais (22/03/2021)

  0
• Collecting data after trial site closed

  Eloise Britten

  Eloise Britten (19/03/2021)

  3
• IB stop delivery to sites and ECs

  Mihaela Nosca

  Mihaela Nosca (17/03/2021)

  5
• Follow up of the drug compliance by the patient regards oral medication

  Ruth

  Dominique Chesnais (17/03/2021)

  2
• US FDA Guidance on Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency [Updated: 27Jan2021]

  Aldwin Aldana

  James Brolin (16/03/2021)

  1
• GCP Gap Analysis

  Anon

  Anon (15/03/2021)

  3
• China HGRAC and use of eDC

  Anon

  Anon (15/03/2021)

  0
• Simple eTMF for virtual Sponsor

  Jane Self

  Dominique Chesnais (15/03/2021)

  3
• Protocol training

  Anon

  Juergen Kaetzler (15/03/2021)

  2
• New Labs doing exploratory work after study closure

  Margaret McKee

  Dominique Chesnais (13/03/2021)

  3
• Sub-investigator

  Tamara

  Colin Wilsher (09/03/2021)

  10
• Blood volume, informed consent

  MS

  Angela McCullagh (09/03/2021)

  6

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