What is it? Why is it important?
The sponsor-investigator (SP-INV) is legally responsible to ensure participant protection and reliability of study results. In order to safeguard these aims a risk based QMS, including QA and QC procedures, must be established based on the study design and implementation.
A risk based approach includes to:
- Define activities and their inherent risks
- Evaluate and prioritise risks (e.g. frequency and impact)
- Define risk control measures (e.g. accept, tolerate, reduce, eliminate risks)
- Report risk event(s) and measures taken to prevent reoccurrence
The SP-INV can delegate QMS responsibilities to:
- A CRO or CTU, with a contract defining delegated tasks
- Local staff members, with a delegation log defining delegated tasks
Ultimate study responsibility remains with the SP-INV, who ensures the qualification and training of its partners and staff members.
What do I need to do?
Familiarise yourself with:
- The role and responsibilities of a study SP-INV (e.g. regulatory and GCP requirements)
- Training requirements (e.g. GCP certificate)
- How to set-up a risk based QMS for your study
- Keep main focus on patient safety and reliability of trial results
- Include QA and QC procedures
- Consider regional or local QMS requirements (e.g. multi-centre studies)
- How to document, communicate and train risk management activities
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 guideline
- 5.0 Quality management
ISO 31000 – see in particular section
- Risk management: Principles and guidelines (access liable to costs)
ClinO – see in particular article
- Art. 2 Definitions