Good Clinical Practice Discussion Forum

• eCRF data listings

  Ludmila Kutakova

  Ludmila Kutakova (17/06/2019)

  0
• Non-GCP compliant lab responsible for validation

  Line

  Colin Wilsher (14/06/2019)

  1
• Informed consent-highlighted section

  Ana

  Colin Wilsher (12/06/2019)

  1
• Quality Agreement between sponsor & CRO

  Aurelie Fuchs-Wingert

  Colin Wilsher (28/05/2019)

  1
• eTMF access

  Anon

  Dominique Chesnais (28/05/2019)

  2
• ISR failure

  Meet

  Colin Wilsher (27/05/2019)

  1
• serious breach FDA

  MS

  MS (24/05/2019)

  3
• Note to File to an SOP

  Ana

  Dominique Chesnais (24/05/2019)

  2
• Bioanalytical data obtained from Chinese CROs

  Sus

  Colin Wilsher (23/05/2019)

  2
• Japanese Regulation

  Ruth Lopez

  Henrieke (23/05/2019)

  4
• Lab accreditation for a hospital lab

  Anon

  Anon (19/05/2019)

  2
• Short format DSUR for Type A trials - due dates

  Paula

  Colin Wilsher (08/05/2019)

  3
• Closing Site for Non-compliance

  Larisa

  Larisa (08/05/2019)

  4
• Electronic 'shadow' TMF

  Anon

  Colin Wilsher (02/05/2019)

  3
• EU Regulation number 536/2014 and SUSAR

  Ana

  D Chesnais (29/04/2019)

  3
• Does an LMS need to be 21 CFR Part 11 compliant

  Michael

  Trev Simmons (DIGIT) (25/04/2019)

  4
• Sharing CAPAs

  Bert

  Colin Wilsher (24/04/2019)

  3
• eTMF printout

  Anon

  Colin Wilsher (16/04/2019)

  3
• Auditing of micro lab services to support a pHase 2 clinical study

  Jane Self

  RQA GLP Committee (16/04/2019)

  1
• CSR wording vs protocol

  Anon

  Anon (15/04/2019)

  1

Share your experience on trustpilot.com