What is it? Why is it important?
- Prevent mistakes, problems, or defects
- Guarantee data quality with the aim to provide confidence in study results (e.g. study results are traceable and credible)
- Ensure the rights and ongoing safety of study participants during study conduct, and as applicable follow-up
- Ensure the ongoing compliance with applicable laws (e.g. Swiss law), Ethics Committee (EC), regulatory authorities (RA) (e.g. Swissmedic, FOPH), guidelines (e.g. ICH GCP, ISO 14155), and local procedures (e.g. SOPs, WIs)
The aim of QA in a study is to give assurance to the SP-INV and ultimately to EC/RA that processes are reliable and that no major system failures are expected to occur that would:
- Expose patients to unnecessary risks or violate their legal or ethical rights
- Risk the integrity of study results (e.g. data must be generated, documented and reported in compliance with ICH GCP and applicable regulatory requirements)
What do I need to do?
As a SP-INV:
- Implement and maintain a QA system covering study set-up and conduct, and if applicable follow-up
- Describe and document QA relevant processes in SOPs and WIs (e.g. the informed consent process, safety reporting procedures, randomisation procedures)
- Describe QA procedures for data entry and data handling during study conduct
- Describe QA procedures to ensure compliance with the study protocol, EC, ICH GCP and regulatory requirements
- Ensure study staff is properly trained on QA procedures and their respective tasks and responsibilities
SOPs and WIs give details on how QA guidelines, standards and requirements will be implemented in core study activities - in daily work.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 5.0 Quality management
- 5.1 Quality assurance and quality control
ISO 9001:2015 (access liable to costs) – see in particular section
- Quality Management Systems