Development↦Quality and Risk↦Quality Assurance↦Quality Documents
What is it? Why is it important?
Quality documents are written verifiable records on study activities with the aim to build confidence in study results (e.g. accurate reporting, interpretation of results).
Quality Documents include:
- Essential study documents
- Supporting documents needed to support the quality of work, and which are also used outside the study (e.g. local directives such as emergency processes by freezer failure)
- Non-essential study documents that facilitate daily work, (e.g. checklists, memos)
Essential documents:
- Are defined in chapter 8 of ICH GCP
- Are operational documents that allow study activities to be retraced
- Play a key role in successful study management
- Are filed in the TMF/ISF of the study
- Provide written evidence on implemented quality measures (e.g. Quality Assurance, Quality Control)
- Provide written evidence that the study was conducted in compliance with the study protocol, the law (e.g. Swiss law) ICH GCP, EC, applicable regulatory authorities (e.g. Swissmedic, FOPH), including other relevant guidelines (e.g. ISO 14155)
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Requirement and extent of collected quality documents depend on identified risks, their prioritisation and risk control-measures, including study type (ClinO, HRO) and risk category (A, B, C).
Example of essential documents:
- Study protocol
- Participant information and Consent (ICF)
- Case report forms
- Standard Operating Procedures (SOPs)
- Working Instructions (WIs)
- Logs (e.g. participant enrolment and identification, IMP/IMD inventory and dispensing)
- Staff qualification (e.g. CV, study trainings, further education)
- Certificate (e.g. ICH GCP training, laboratories accreditations)
- Contracts and insurance (e.g. service providers and partners)
- IMP/IMD handling instructions, labelling, and shipment records
- Biobank certification
- etc.
What do I need to do?
As a SP-INV:
- Define and make a list of quality documents applicable to your study. Iincluding Quality Assurance and Quality Control aspects.
- Develop applicable SOPs, WIs, and processes needed for Quality Assurance and risk control
- Finalise those essential documents that must be submitted to the Ethics Committee (EC) and if applicable RA (e.g. Swissmedic) (e.g. study protocol, ICF, CRF, contracts, budget, insurance)
- Start preparing other relevant quality documents (e.g. useful checklists showing work flow)
- Include study team members as potential quality documents reviewers
- Train study staff regarding the understanding and application of quality documents
Site-INV responsibilities:
- Implement quality documents provided by the SP-INV of the study
- If needed, define and write local SOPs, WIs, and logs to be approved by the SP-INV.
- Ensure that essential documents such as logs (e.g. delegation-, medication log) are complete, current and signed
For more information refer to Documents in this Study Guide
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In order to retrace study activities, essential documents are:
- Reviewed by operational staff
- Reviewed for accuracy and completeness by the study monitor during monitoring visits
- Inspected by RA (e. g. Swissmedic) during study inspections in order to evaluate compliance with the study protocol, the safe conduct of the study such as safety reporting procedures, data collection and the quality of obtained data
- Archived upon study termination for a defined period of time, depending on type of study, regulatory and local requirements
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
References
ICH GCP E6(R2) – see in particular guidelines
- 5.1 Quality assurance and quality control
- 8.0 Essential documents
ISO 9001: 2012 - see in particular section (access liable to costs)
- Quality Management System