Good Clinical Practice Discussion Forum

• eCRF final prior to recruitment start

  Juergen Kaetzler

  Juergen Kaetzler (28/10/2020)

  3
• Full service CRO qualification

  Anne-Mie Lenaers

  Anne-Mie Lenaers (28/10/2020)

  6
• Quality Assurance vs Compliance roles

  Anon

  Juergen Kaetzler (27/10/2020)

  4
• Exploratory studies

  Susanne Gelvan

  Juergen Kaetzler (27/10/2020)

  9
• Import License needed from non EU country to Germany?

  Anon

  Anon (23/10/2020)

  4
• GCP and/or ISO 14155 training evidence

  Anon

  Juergen Kaetzler (21/10/2020)

  3
• CV of PI and Sub-I

  Shah Ashraf

  Shah N Ashraf (15/10/2020)

  8
• Risk Management by CRO

  Anne-Mie Lenaers

  Dominique Chesnais (14/10/2020)

  3
• Trial subjects and social media

  Anon

  Anon (09/10/2020)

  3
• Remote SDV

  Anon

  Dominique Chesnais (03/10/2020)

  3
• Delegation of Significant study-related duties by the investigator

  Mugagga Agnes M

  Mugagga Agnes Mary (02/10/2020)

  4
• Change in Sponsor Address

  SW

  Colin Wilsher (02/10/2020)

  1
• Are there any regulations that define whether an audit trail should be stored together with the data??

  Ilonka Schoester

  Dominique Chesnais (02/10/2020)

  2
• Patient Reported Outcomes - Linguistic Validation

  MS

  Colin Wilsher (02/10/2020)

  1
• EMA's notice to sponsors on validation and qualification of computerised systems used in clinical trials

  Mathias Madsen

  Mathias Madsen (01/10/2020)

  8
• Staff blood samples

  Anon

  Dominique Chesnais (25/09/2020)

  4
• GCP or GCLP?

  HL

  HT (24/09/2020)

  3
• Contracting site staff on behalf of the investigational sites

  Anon

  Colin Wilsher (22/09/2020)

  1
• PI change: is it required that the old PI stops all delegated tasks and the new PI re-starts these tasks?

  Juergen

  Juergen Kaetzler (15/09/2020)

  6
• freezer location

  Maira

  Colin Wilsher (11/09/2020)

  3

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