Development↦Quality and Risk↦Quality Control↦Aim
What is it? Why is it important?
Quality Control (QC) is an essential part of Quality Assurance, using a systematic review of implemented study procedures and processes 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
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 QMS aims at managing study risks to ensure the safety and quality of the study.
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Example of QC measures
Monitoring plays a key role in helping the SP-INV to evaluate compliance and perform QC checks at participating study sites.
Quality indicators include to:
- Ensure patient eligibility criteria are consistently respected and followed as defined in the study protocol
- Ensure traceability by properly documenting Informed Consent (IC) and comply with the IC process
- Adhere to safety reporting timelines
- Ensure adherence to scheduled study visits and procedures (e.g. blood draw, questionnaire, timing), including their documentation
- Complete data entry within required timelines
- Document study visit in the CRF, and ensure updates are entered in medical records
- Document and track 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 activities 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, centralised)
- Extend of data processing checks
Monitoring is an important QC activity used to monitor study conduct. To ensure compliance with QC activities its strategy should be documented in a monitoring plan.
For more information refer to Monitoring in this Study Guide
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Based on the QC strategy of your study provide applicable:
- Written SOPs and WIs: These documents give detailed guidance on how standards, processes, and given requirements should be implemented in study core activities - in everyday 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 Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
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 (access liable to costs) – see in particular section
- Quality Management Systems