Good Clinical Practice Discussion Forum

• Medical Records retention

  Anon

  ANGELA MCCULLAGH (02/12/2021)

  4
• Recruitment/Call Center

  Anon

  Anon (02/12/2021)

  1
• Archiving of Emails - alternative to pdf

  Anon

  Muriel Cottard (01/12/2021)

  7
• minimum SDV requirements/interpretation of "verify"

  Vaul

  Vaul (30/11/2021)

  6
• Remote SDV

  Kerry Bunyan

  Vaul (25/11/2021)

  9
• US Multi Centre Study - No Coordinating Investigator

  Vanessa Hyde

  Aldwin Aldana (16/11/2021)

  6
• Patients full name in EDC/US study

  Anon

  Aldwin Aldana (16/11/2021)

  2
• Certified copies

  Anon

  Cristina Monastero (16/11/2021)

  3
• E-Archiving

  Kate Rolfvondenbaumen

  Cristina Monastero (16/11/2021)

  4
• Risk management in CT

  Anon

  Colin Wilsher (14/11/2021)

  1
• Delegation of authority of third party

  Ana Villarreal

  Ana Villarreal (12/11/2021)

  3
• Investigator's Brochure SOP

  Anon

  Shaun Hastings (12/11/2021)

  2
• Protocol Amendment Updates

  AN

  Shaun Hastings (12/11/2021)

  2
• CRF (EDC - data + metadata) retention in dynamic file format.

  Anon

  Hanna Preus (26/10/2021)

  3
• Regulations Guidances

  Anon

  Colin Wilsher (21/10/2021)

  4
• Updated Protocol Deviation Rules

  syngB

  Colin Wilsher (21/10/2021)

  3
• GCP Audit

  Aline

  Aline (20/10/2021)

  2
• URS of LMS and LCMS

  Nayan Prajapati

  RQA GLP Committee (20/10/2021)

  7
• Hybrid TMF

  Anon

  Colin Wilsher (04/10/2021)

  1
• Medical Monitors

  KH

  Collin Stoun (27/09/2021)

  4

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