Development↦Quality and Risk↦Quality Processes↦Development
Was betrifft es? Warum ist das wichtig?
Study Quality Processes are a set of defined instructions that ensure that the study:
- Is implemented in a consistent and reproducible manner
- Complies with Quality Assurance requirements
The development of study quality processes includes to:
- Identify processes required for the implementation of the study, such as: informed consent, protection of participant right and safety, data handling, handling of biological material (e.g. sample workflow), statistical analysis (e.g. SAP), partner collaborations (e.g. pharmacy, laboratory, managing of participating study sites
- Identify laws and guidelines that apply to identified processes (e.g. Swiss law, FOPH, ethical principles, ICH GCP, ISO 14155 / Biobanking)
- Document processes (e.g. SOPs, WIs, check-lists, manuals), as they:
- Are needed as a reference by study staff to comply with study conduct requirements
- Provide documentation on how the study was conducted
- Validate (test) processes to guarantee applicability and feasibility (e.g. resource requirements such as staff and infrastructure)
- Approve and release process documents to support faultless compliance during study implementation
Mehr
The identification, documentation, and validation of study processes are essential parts supporting the Quality Assurance approach of a study.
Applying for study approval requires the submission of selected quality documents. The Ethics Committee (EC), and if applicable Swissmedic, approve, among others, the study based on the quality and completeness of its quality processes.
Example of quality processes that may be requested by EC / Swissmedic for an assessment at study approval
- The study protocol
- Informed consent process, including PIS and ICF
- Data collection, including study design and potential blinding procedures
- Document Management (e.g. document identification and filing)
- Staff education and training requirements
- Partner collaborations (e.g. data manager, statistician)
- IMP / IMD handling, labelling, and shipment instructions
Laboratory, Biobank certification
Was muss ich befolgen?
As a SP-INV:
- Implement a Quality by Design approach, by focusing on Critical to Quality factors during the deelopment of quality processes
- Plan Quality Control measures (e.g. monitoring, partner audit) during study conduct to:
- Plan how to ensure study staff is trained on process responsibilities and implementation, including process adaptions during study conduct
Document-Management-responsibilities in studies ensure that:
- Approved and released quality processes are:
- Identifiable (e.g. version number, date from when the document is valid, process authorship)
- Readily accessible to study staff
- Protected from accidental alterations and loss
- Archived processes are clearly marked to prevent the accidental retrieval of archived processes
- Guarantees that only valid processes remain in circulation during study conduct
Mehr
Staff trainings must be documented on a training-log. Both trainer and trainee date and sign the study training-log. By signing the training-log, trainees confirm to have read and understood its content.
On the training-log reference is made on the type of documents that were trained (name, date, version number, etc.).
Staff trainings are documented and performed:
- By qualified trainers or through self-training
- On site, by telephone or web-based
- Both at study initiation and during study conduct
- Based on study delegated tasks and responsibilities (e.g. delegation-log)
- Prior to executing a task
- Upon changes to study documents (protocol, IC, SOPs. WIs, processes)
- Upon change of study staff or individual responsibilities
Wo kann ich Hilfe anfordern?
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
- 3.10 Quality management
- 3.11 Quality Assurance and Quality Control
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