Good Clinical Practice Discussion Forum

• Updated: US FDA Guidance Document on Conducting Clinical Trials of Medical Products During the COVID-19 Pandemic [Updated:27March2020]

  Aldwin Aldana, MS

  Aldwin Aldana, MS (30/03/2020)

  0
• COVID-19: developers of medicines or vaccines to benefit from free scientific advice (EMA)

  Dominique Chesnais

  Dominique Chesnais (28/03/2020)

  0
• EMA New Draft Guideline on Methodological Considerations for Clinical Trials During COVID-19 Pandemic for Public Consultation [Due: 25 April 2020]

  Aldwin Aldana

  Aldwin Aldana (26/03/2020)

  0
• Inclusion of home healthcare (HHC) nursing staff (contracted either by Sponsor or SMO) in the Site Delegation of Authority (DOA) Log

  Aldwin Aldana

  Aldwin Aldana (26/03/2020)

  13
• Australian TGA Guidance on Conducting Clinical Trials During COVID-19 Pandemic

  Aldwin Aldana

  Aldwin Aldana (25/03/2020)

  0
• Health Canada's Notice to Clinical Trial Sponsors [23 March 2020]

  Aldwin Aldana

  Aldwin Aldana (25/03/2020)

  0
• Electronic signatures - need for a validated system?

  Anon

  Dean Harris - DIGIT Committee Member (24/03/2020)

  2
• New EU Guidance Document for Sponsors in Managing Clinical Trials during the COVID-19 Coronavirus Pandemic

  Aldwin Aldana

  Colin Wilsher (24/03/2020)

  1
• Germany: Review/Sign eCRF

  Anon

  Margit Zehrer (23/03/2020)

  15
• Breaking News: US FDA Issues Guidance Document on Conducting Clinical Trials During the Coronavirus Pandemic

  Aldwin Aldana

  Colin Wilsher (18/03/2020)

  1
• Share Audit Findings

  Ana

  Margit Zehrer (13/03/2020)

  3
• Site staff CVs

  Karen

  Gryshyn Sergii (13/03/2020)

  5
• eTMF

  Anon

  Colin Wilsher (10/03/2020)

  2
• CV of had of laboratory needed

  DE

  Colin Wilsher (09/03/2020)

  2
• US FDA 1572 - completion for ex-US sites

  Anon

  Colin Wilsher (04/03/2020)

  8
• Data collected prior to Informed Consent

  Anon

  Colin Wilsher (28/02/2020)

  4
• Re-screening and IC

  Anon

  D Chesnais (28/02/2020)

  3
• Management of source documents at satellite sites

  Mona

  Anon (24/02/2020)

  3
• Typewriter generated source documents

  Alon Rayhman

  Colin Wilsher (24/02/2020)

  3
• Certified copies

  Anon

  Anon (23/02/2020)

  7

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