Good Clinical Practice Discussion Forum

• Retention period of Bioanalysis documentation

  RUTH LOPEZ MAGDALENO

  Colin Wilsher (05/06/2020)

  4
• Germany: Review/Sign eCRF

  Anon

  Erica Sage (04/06/2020)

  16
• Fit-for-purpose Quality Oversight Framework for RWD/E in research projects

  Dagmar Goertz

  Dominique Chesnais (31/05/2020)

  5
• Record of vital signs

  Diana

  Dominique Chesnais (29/05/2020)

  2
• eCRF distribution to site

  Martin Miller

  Dominique Chesnais (28/05/2020)

  2
• Freezer used for clinical trials, qualification process, ISO 17025 need

  DE

  DE (26/05/2020)

  0
• Requirement of Quality Manual

  Ruth Lopez

  Colin Wilsher (25/05/2020)

  6
• Updated: US FDA Guidance Document on Conducting Clinical Trials of Medical Products During the COVID-19 Pandemic [Updated:27March2020]

  Aldwin Aldana, MS

  Colin Wilsher (15/05/2020)

  5
• Expired controls

  Horace

  Colin Wilsher (14/05/2020)

  1
• EMA guidance SDV

  anon

  Dominique Chesnais (13/05/2020)

  4
• Subject Medical History

  Anon

  Colin Wilsher (08/05/2020)

  1
• Investigator Initiated Studies

  Anon

  Colin Wilsher (06/05/2020)

  2
• Approval of documents via email instead of the wet-ink signatures while working from home in COVID-19 situation

  Anon

  Colin Wilsher (05/05/2020)

  1
• Storing documents on sharepoint or shared area

  Anon

  d.chesnais@hotmail.co.uk (02/05/2020)

  2
• eTMF solution

  Anon

  Dominique Chesnais (02/05/2020)

  3
• Practical guidance of the CMDh

  Dominique Chesnais

  Dominique Chesnais (24/04/2020)

  0
• Free US FDA CDER SBIA Webinar on 30APR2020 for Conducting Clinical Trials During the COVID-19 Public Health Emergency

  Aldwin Aldana

  Aldwin Aldana (23/04/2020)

  0
• ICMRA meeting: COVID-19 Real-World Evidence and Observational studies

  Dominique Chesnais

  Dominique Chesnais (17/04/2020)

  0
• PhV training in the field of clinical trials

  Jordi

  Jordi (15/04/2020)

  4
• Use of DocuSign/validation needed?

  Anon

  Colin Wilsher (09/04/2020)

  2

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