Development↦Management↦Responsibilities↦Staff Qualification and Training
What is it? Why is it important?
In a study, staff qualification, training and delegated responsibilities must be clearly defined.
All members of a study team must be qualified by education and training prior to:
- Taking on study related responsibilities
- Performing study related tasks
Requirements must be documented such as:
- A site organigram: structural and organisational relationships
- CV: education, continuous education, job experience
- Training: GCP / ISO14155, continuous education
- Previous study experience
- Delegation Logs: Definition of delegated study responsibilities
More
Staff trainings should be done:
- By qualified trainer(s) or through self-training
- On site, by phone or web-based
- Both at study initiation and during study conduct
- Prior to performing any training required study delegated task
- Upon changes of study relevant documents (e.g. study protocol, ICF, SOPs)
- Upon change of study relevant staff or delegated responsibilities
Upon training, the trainer and trainee date and sign the training log. By signing, the trainee confirms to have read and understood the content of the given training.
What do I need to do?
Select appropriately qualified staff based on:
- Professional qualifications (e.g. education, experience)
- Study specific requirements
Establish a staff management folder that includes study staff education and training documents:
- CVs
- GCP / ISO14155, continuous education
- Applicable study SOPs and WIs
Ensure training logs including job descriptions are up-to-date, and personally dated and signed.
Document and approve any study delegated tasks to individual study staff.
More
On the training log, always refer to type of document(s), material(s) or other aid(s) used during training, (e.g. include name of document, validation date, and version number).
As documents are subject to ongoing changes, version or release dates are adapted accordingly. Only by including document details, can it be guaranteed that staff received the appropriate training(s).
Required study specific qualifications may include but are not limited to:
- Project management
- Study coordination
- Safety and risk management
- Statistics and methodology
- Various medical examination and analysis
- Handling of data and electronic data capture
- Handling of biological material and analysis
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
External Links
Swissethics – see in particular
- Information on professional qualifications
- List of persons conducting a study
References
ICH GCP E6(R2) – see in particular guidelines
- 4 Site-INV responsibilities
- 5 SP-INV responsibilities
ISO 14155:2020 Medical devices - see in particular sections (access liable to costs)
- 9 Responsibilities of the sponsor (SP-INV)
- 10 Responsibilities of the principal investigator (Site-INV)
Swiss Law
ClinO – see in particular article
- Art. 6 Professional qualifications
HRO – see in particular article
- Art. 4 Professional qualifications