Good Clinical Practice Discussion Forum

• Medical Device storage and shipment

  Anon

  Anon (22/01/2021)

  1
• Medical Device storage and shipment

  Anon

  Colette McIntyre (22/01/2021)

  1
• Medical Device storage and shipment

  Anon

  Anon (22/01/2021)

  0
• Safety Reporting for a Natural History study

  Anon

  Dominique Chesnais (19/01/2021)

  4
• Unblinded sponsor team

  Anon

  Dominique Chesnais (17/01/2021)

  3
• PMDA Japan Extension of Remote GCP Inspections Until 30Jun2020

  Aldwin Aldana, MS, RQAP-GLP, MRQA

  Aldwin Aldana, MS, RQAP-GLP, MRQA (15/01/2021)

  0
• GMP manfacture for clinical trials in Asia

  McSweeney

  Anthony Moult (14/01/2021)

  2
• Correct end date of a Serious Adverse Event

  Nadine Roethling

  Nadine Roethling (13/01/2021)

  5
• Brexit

  Sabrina

  Anon (07/01/2021)

  5
• Mozersky et al. (2020). How do clinical research coordinators learn Good Clinical Practice?

  Aldwin Aldana, MS, RQAP-GLP, MRQA

  Juergen Kaetzler (25/12/2020)

  6
• Import License needed from non EU country to Germany?

  Anon

  Juergen Kaetzler (22/12/2020)

  7
• US FDA BIMO GLP/GCP Inspectional Observations for Fiscal Year 2020

  Aldwin Aldana, MS, RQAP-GLP, MRQA

  Aldwin Aldana, MS, RQAP-GLP, MRQA (17/12/2020)

  0
• Remote Close out visit

  Margaret

  Juergen Kaetzler (15/12/2020)

  5
• US FDA 1572 - completion for ex-US sites

  Anon

  Aldwin Aldana, MS, RQAP-GLP, MRQA (15/12/2020)

  11
• Clinical Quality Agreement

  Mar

  Aldwin Aldana, MS, RQAP-GLP, MRQA (15/12/2020)

  6
• Verbal medical history

  Anon

  Dominique Chesnais (15/12/2020)

  5
• Details on GC Inspection Findings

  Anon

  Juergen Kaetzler (14/12/2020)

  2
• inform consent

  roxana gheorghiu

  Colin Wilsher (11/12/2020)

  1
• Informed Consent

  Ioanna

  Juergen Kaetzler (10/12/2020)

  5
• EU-US privacy shield/transfer of data outside EEA

  Basil

  Dominique Chesnais (09/12/2020)

  4

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