Good Clinical Practice Discussion Forum

• 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
• Audit of medical writing service providers

  Anon

  Colin Wilsher (23/09/2019)

  1
• Calibration of check weights in a GCP compliant laboratory

  Anon

  Colin Wilsher (20/09/2019)

  3
• GCP Certificates of Sponsor/ CRO Trial Team Members

  Dickson

  Colin Wilsher (18/09/2019)

  3
• The same SOP Deviation ( Temp range) on multiple studies

  Anon

  anon (16/09/2019)

  1
• Risk Log

  anon

  Anon (13/09/2019)

  1
• Contacting subjects after they have completed a study

  Joanne

  Joanne (28/08/2019)

  2
• Retention Samples in Clinical Trials

  Ruth Lopez

  Anon (23/08/2019)

  1
• Investigator initiated trials - pharma responsibilities

  MS

  MS (22/08/2019)

  2
• IIT and pharma company input

  Laure

  Anon (21/08/2019)

  1
• International Certification for GCP Auditors

  Ruth Lopez

  Ruth Lopez (20/08/2019)

  5
• CRA access to EHR

  Ana

  Colin Wilsher (19/08/2019)

  1

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