Good Clinical Practice Discussion Forum

• AE related unblinding

  LM

  Olga Blokhina (07/12/2019)

  4
• FDA 1572 and delegation Log-Radiology department

  Ana

  Colin Wilsher (05/12/2019)

  2
• Sofware to manage the recruitment of participants

  Diana

  Diana (26/11/2019)

  2
• The same SOP Deviation ( Temp range) on multiple studies

  Anon

  RQA GLP Committee (20/11/2019)

  2
• SOP/GCP training effectiveness

  Anon

  Anon (19/11/2019)

  3
• Retention Samples in Clinical Trials

  Ruth Lopez

  GMP Committee response (15/11/2019)

  3
• CRO Sharing SOPs with Sponsors

  Anon

  Colin Wilsher (10/11/2019)

  3
• Certified copies

  Anon

  Colin Wilsher (07/11/2019)

  5
• SOP effective dates

  Anonymous

  Anon (05/11/2019)

  5
• Initialing and Signature on PIS ICF by study participant

  Anon

  Anon (18/10/2019)

  4
• Clinical Data Integrity

  Aurelie Fuchs-Wingert

  Andrea Pucci (18/10/2019)

  4
• SUSAR cover letter

  Eleonora

  Anon (10/10/2019)

  1
• PI in two sites

  Jordi

  Anon (10/10/2019)

  3
• ISO 14155

  Anonymous

  anon (09/10/2019)

  1
• Collection of eace and ethnicity data in Clinical Trials in Europe

  Eleonora Scorpiniti

  Eleonora Scorpiniti (08/10/2019)

  2
• Certified copies

  Anon

  Trev Simmons (DIGIT) (07/10/2019)

  3
• 21 CFR part 11 in Europe

  Eleonora Scorpiniti

  Eleonora Scorpiniti (07/10/2019)

  3
• Germany: Review/Sign eCRF

  Anon

  Emad Ansari (04/10/2019)

  6
• Consent in Retrospective Data Trials

  Emma Damoulakis

  Sara (03/10/2019)

  2
• Signature and Date stamps

  Anon

  Colin Wilsher (26/09/2019)

  5

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