What is it? Why is it important?
Study quality documents (QD) enable operational staff, monitors, auditors and inspectors to evaluate compliance with the study protocol, the safe conduct of the study, and the quality of obtained data.
Preparation of QD start during the development phase and must be finalised and implemented before the SIV.
Example of quality documents:
- Study protocol
- Participant information & Consent
- Standard Operating procedures (SOPs)
- Worksheets (WI)
- Logs (e.g. participant enrolment, identification, IMP/MD inventory and dispensing, staff trainings)
- Certificates (e.g. laboratories, service providers)
- Staff qualification (e.g. CV, further education)
What do I need to do?
- Make a list of QD needed for your study and make applicable adaptations when using previously implemented QDs
- Submit applicable QD to the EC/RA for approval and make modification as requested (e.g. study protocol)
- Distribute and train staff regarding the understanding and application of QD
- Implement revised documents provided by SP-INV. This might require feedbacks and signatures
- If needed, modify local SOPs, WIs and Logs needed for the study
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 5.0 Quality management
- 5.2.2 Addendum: Sponsor oversight
ISO 9001:2015 – see in particular section
- Quality Management Systems (access liable to costs)