Development↦Quality and Risk↦Quality Control↦Aim
What is it? Why is it important?
The aim of Quality Control (QC) is to periodically review implemented procedures and processes in the study in order to ensure that:
- The study is conducted in compliance with the study protocol, study SOPs, ICH GCP, and applicable laws (e.g. Swiss law)
- Data is correctly generated, collected, handled, and analysed
QC is an integral part of Quality Assurance (QA) and includes activities and techniques used to systematically check study compliance. Non-compliance results in findings that must be addressed and resolved.
In this regard, the SP-INV is responsible to implement a risk-based QMS. A risk-based approach to QMS aims at managing study risks needed to ensure the safety and quality of the study.
Example of QC measures
Monitoring is an important medium used by the SP-INV to evaluate compliance and perform QC checks at participating study sites.
Quality indicators include, but are not limited to:
- Patient eligibility criteria consistently respected and abided by as defined in the study protocol
- IC process correctly documented ensuring traceability
- Adherence to safety reporting timelines
- Scheduled visits and applicable procedures are followed and documented (e.g. blood draw, questionnaire, timing)
- Data entry completed within required timelines
- Study visit documented in CRF, updates entered in medical records
- Documentation on staff trainings (e.g. ICH GCP certificate, IC process, IMP/IMD handling)
- Correct handling of the investigational product (e.g. IMP/IMD access and temperature control, inventory log with traceability on dispense, return, destruction)
What do I need to do?
As a SP-INV define the QC strategy for your study. Base QC control actiivities according to identified study risks, such as:
- eCRF automatic alerts in the event of out-of-range data entries
- 24 hours temperature surveillance of freezers storing biological material, including an efficacy check of the emergency plan process
- Ongoing study monitoring adaptions (e.g. number of total visits, extent of document and SD checks, type of monitoring visit (e.g. on-site, central))
- Extend of data processing checks
Monitoring is an important QC activity used to monitor study conduct. In order to ensure compliance with QC control activities its strategy should be documented.
For more information refer to Monitoring in this Study Guide
Based on the QC strategy of your study provide applicable:
- Written SOPs and WIs. These documents give detail guidance on how standards, processes, and given requirements should be implemented in core study activities - in every day work
- Guidance on the handling of study risks, by documenting the risk management of your study in a RAF (e.g. including quality document)
- Ensure to train staff on the QC activities of your study
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
- 1.47 QC definition
- 5.1 Quality assurance and quality control
- 5.18 Study monitoring
ISO 9001:2015 – see in particular section
- Quality Management Systems (access liable to costs)