Development↦Quality and Risk↦Quality Control↦Aim
What is it? Why is it important?
Quality Control (QC) is an essential part of Quality Assurance, where a set of procedures are implemented to assess if a study is correctly and consistently conducted according to:
- The Ethics Committee (EC), and if applicable Swissmedic, approved study protocol
- Applicable regulatory requirements (e.g. Swiss Law, FOPH, international)
- Applicable guidelines (ICH GCP, ISO 14155, Biobanking)
- Study quality processes / documents (e.g. SOPs. WIs)
- Ethical principles
The main aim of QC is to:
- Ensure the rights and safety of study participants are protected (e.g. correctly implemented consent procedures)
- Correct handling of study data (e.g. data confidentiality, data quality)
- Correct handling of the investigational therapeutic product (e.g. storage, administration, inventory-log)
- Ensure study staff is trained on study procedures and changes (e.g. protocol amendment, risk control-measures adaptations)
- Detect and explain root-cause of non-compliance, with the implementation of Corrective and Preventive Action (CAPAs)
A main QC activity used by SP-INVs is the planning and implementation of study monitoring.
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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 consent traceability, with proper documentation of Informed Consent ((IC) according to an approved IC SOP
- Adhere to safety reporting timelines (e.g. safety reporting procedures)
- Ensure adherence to scheduled study visits and procedures (e.g. blood draw, questionnaire, timing), including documentation
- Complete data entry within the required timeline
- 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 therapeutic product (e.g. IMP/IMD access and temperature control, inventory-log with traceability on dispense, return, and destruction)
What do I need to do?
As a SP-INV, apply a risk-based approach to your QC stratefy, and:
- Define a risk-based monitoring strategy to your study (e.g. scope, frequency, and modality (on-site, central monitoring) of study monitoring activities)
- Based on defined quality processes, provide written SOPs and WIs for study training and study conduct (e.g. guidance on how standards, processes, and given requirements are implemented in core study activities)
- Implement a risk-based Quality Management System, which provides guidance on how to handle study risks (e.g. risk identification, risk control-measures, risk documentation)
- Define follow-up procedures regarding non-compliance to ensure CAPAs are correctly implemented
- Define procedures for the tracking of study trainings, including trainings regarding updates or changes to study activities
Guided by a Quality-by-Design approach to your study, implement a risk-based monitoring strategy that focuses on risks threatening the Critical-to-Quality factors of your study.
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As a SP-INV:
- Define the risk-based monitoring of your study by defining the appropriate scope, frequency, and monitoring type (centralized, on-site, or hybrid)
- Develop a Monitoring Plan, outlining the monitoring strategy of your study (e.g. extent and nature of monitoring)
- Appoint an independent monitor with relevant scientific knowledge and experience
- When outsourcing monitoring services, ensure to document its strategy, responsibilities, and costs in a applicable contract
- Inform and ensure participating Site-INV(s) provide monitors with access to required on-site documents needed for the implementation QC activities
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(R3) – see in particular guidelines
- Glossary Definitions: QC, Compliance, Monitoring, Monitoring Plan definition, Confidentiality
- 3.11 Quality assurance and quality control
- 3.11.3 Quality Control
- 3.12 Noncompliance
- 3.11.4 Monitoring
ICH E8(R1) – see in particular
- 3.1 Quality by Design of clinical studies
- 3.2 Critical to Quality Factors
ISO 9001:2015 (access liable to costs) – see in particular section
- Quality Management Systems
ISO 14155 (access liable to costs) – see in particular section
- 8.2.4 Monitoring