CRC 03.1 Contents of Sponsor file V1Page 1 of 2

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/ University of Cape Town
Clinical Research Centre / Contents of Sponsor file

Protocol number/title:

Investigator (indicate PI, National, coordinating):

1. Personnel

  • Contact details
  • Signatures of, and delegation of responsibilities/duties to, site team
  • Up to date CVs for site team

2. Signed protocol and amendments

3. Information and consent documentation (may be combined with protocol)

  • Original and amended information and consent documents
  • Other information given to participants (including approved adverts)
  • Translation(s), where applicable (including certificates of translations or other adequate documentation of translation)

4. Regulatory approvals (Medicines Control Council)

  • Approval letter(s)
  • Submitted progress and/or final reports, other correspondence (e.g. safety related)

5. Ethics approvals

  • Approval letter(s), including notice of members who attended approval meetings
  • Submitted progress and/or final reports, other correspondence (e.g. safety related)

6. Other approvals (e.g. Provincial)

  • Approval letter(s)
  • Other correspondence including progress reports etc.

7. Data collection

  • Sample CRFs
  • Signed, dated and completed CRFs and corrections

8. Investigational product (some documents may be kept in pharmacy during trial)

  • Original and amended Investigator Brochure (or summary of product characteristics/package inserts)
  • Certificates of analysis, batch testing results etc.
  • Randomisation schedules (and decoding documentation post-trial)
  • Packaging and labelling documentation (including samples of labels)
  • Storage conditions and handling procedures
  • Documentation of supply and return to/from the site, or confirmation of disposal
  • Subject drug accountability records

9. Safety management

  • Template SAE forms
  • Process and contact details for reporting serious adverse events (SAEs)
  • Procedure for breaking the blind including code-break envelopes (or equivalent)
  • SAE reports
  • Data Safety Monitoring Board (or equivalent) Charter and associated documents

10. Laboratories

  • Laboratory accreditation (or equivalent)
  • Normal values, ranges or assay validation methods
  • Record of retained body fluids/tissue samples

11. Data management

  • Database construction, validation and associated procedures

12. Quality control (internal and/or external as required)

  • Pre-study, initiation, monitoring and close out reports, and associated site correspondence
  • Protocol deviations
  • Monitoring other (process, manual, correspondence etc.)
  • Inspection and audit documentation (certificate)

13. Finance, contracts and/or agreements, insurance

  • Budget and relevant contracts (including Sponsorship agreement)
  • Insurance policies

14. General correspondence and file notes

15. Final Report and/or publications

16. Miscellaneous