What is it? Why is it important?
The aim of quality assurance (QA) is to provide confidence that applicable regulations and systematic activities are met in order to safeguard patients and data quality.
QA measures are defined in the QMS and are put in place to:
- Prevent mistakes, problems, or defects with established processes, products or services
- Guarantee data quality and provide confidence that given study results are reliable and credible
- Ensure protection of study participants
- Ensure compliance with applicable regulations, guidelines, standards and required procedures
- Expose patients to unnecessary risks or violate their legal or ethical rights
- Risk the integrity of study results, but assure that data is generated, documented and reported in compliance with GCP and applicable regulatory requirement(s)
What do I need to do?
- Implement and maintain a QA system for study set-up and conduct
- Describe specific processes with written SOPs, WIs (e.g. for safety reporting, randomisation procedures, IC procedures)
- Describe procedures needed to record and report study data based on GCP, regulatory requirements, and specifications given in the study protocol
- Ensure that study staff is appropriately trained on their individual tasks and responsibilities
SOPs and WIs give details on how guidelines, standards and requirements will be implemented in core study activities - in every day work
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
- 5.1 Quality assurance and quality control
ISO 9001:2015 – see in particular section
- Quality Management Systems (access liable to costs)