What is it? Why is it important?
Are documented activities and trainings needed to verify the feasibility of planned study processes, and ensure that performance does not deviate and is executed in a consistent and homogeneous manner.
Verified and approved processes ensure that procedures:
- Remain feasible in their implementation
- Are measurable in their outcome performance
- Can be adapted as required during study conduct
Changes to study processes result in adaptation of quality documents (e.g. SOP, WI, risk assessment).
The current validity of quality document must be clearly recognisable. Documents are:
- Given a version number and date from which its procedures are valid
- Uniquely numbered and signed
- Active documents must be readily accessible to study staff
- Archived documents are kept separate from active documents and are clearly marked as such
- Both active and archived documents are only accessible to study staff in PDF format. This prevents accidental changes to documents
What do I need to do?
- Perform applicable test-runs on risk control – and QA measures as they would be performed during study conduct, (e.g. emergency scenario by freezer failure, spillage of biological material, randomisation procedures)
- Evaluate feasibility, potential disturbances, efficiency of implemented risk control measures (e.g. required resources such as time and staff)
- Make necessary adjustments (e.g. SOPs, WIs, processes)
- Train staff on validated QA procedures and risk control measures
- Document training in training log
Staff trainings are done:
- 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
- Prior to executing a task
- Upon changes of study relevant documents (study protocol, IC, SOPs, etc)
- Upon change of study relevant staff or individual responsibilities
All staff training must be documented. Trainer and trainee date and sign the training log. By signing, the trainee confirms to have read and understood its content.
On the training log always refer to type of documents having been trained (name, date, version number, etc.).
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 5.0 Quality management
- 5.2.2 Addendum: Sponsor oversight
ISO 9001:2015 – see in particular section
- Quality Management Systems (access liable to costs)