Development↦Management↦Responsibilities↦Staff Qualification and Training
What is it? Why is it important?
Study staff represent personnel that contribute to the implementation of a study.
Main study staff supporting the:
- SP-INV include a data manager, statistician, monitor, quality staff, and potentially auditors. Support spans from study planning until completion, followed by study archiving and publication of results
- The Site-INV include study-site physicians, nurses, coordinators, and quality staff. Support typically spans from study set-up until completion, including site relevant archiving
Study staff must be qualified by education, training and experience. This is documented in:
- A site organigram: structural and organisational relationships
- CV: education, continuous education, job experience
The delegation of study tasks can only take place after study relevant trainings which include:
- The study protocol
- The Informed Consent process
- Safety assessment and reporting
- Study relevant SOPs, WIs, Swiss law, ICH-GCP for ClinO studies, ISO14155 for ClinO-MD studies, ISO 20916 of in vitro medical device studies
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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, the 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?
As a SP-INV and Site-INV, select appropriately qualified staff based on:
- Study specific requirements
- Staff qualifications (e.g. education, experience)
Establish:
- A staff management folder that includes staff education, job description and trainings (e.g. CV, job description signed by staff and line manager, ICH-GCP, ISO trainings).
- Training logs for study relevant trainings (e.g. informed consent process, study protocol and its amendments, safety, SOPs, WIs, risk-control measures)
- A study site delegation-log which documents the delegation of study tasks and responsibilities
Ensure staff qualification and training documents remain up-to-date and are personally signed and dated.
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