Set-Up↦Management↦Study Training↦Staff Delegation
What is it? Why is it important?
Study staff must be properly trained on their respective delegated tasks. Training requirements depend on individual responsibilities (e.g. site-delegation-log).
Staff training is:
- Done by a qualified trainer or through self-training
- Done face-to-face, by telephone or other applicable means
- Both at study initiation and during study conduct
- Prior to performing any study delegated tasks
- Upon changes in study relevant documents
- Documented on a training-log either as face-to-face or self-training
Information on a training-log should include:
- A reference to documents used for training (e.g. document version, release date, short description of content)
- A complete list of trained individuals including their respective responsibilities within a study (e.g. study nurse, Site-INV, statistician, data manager)
- Name of trainer and his/her position within the study (e.g. project manager, SP-INV, monitor)
- Date of training and signature of trainer and trainee.
What do I need to do?
As a SP-INV and Site-INV, decide based on your study:
- What are study specific tasks and procedures?
- Who will be responsible for delegated study tasks?
- Based on task, what are the applicable training documents or tools?
- How should the training be done (e.g. face-to-face, self-training, by telephone)?
- Who is the trainer (e.g. task expert)?
- How will the training be documented?
On a training-log, always refer to type of document or tool trained (e.g. name, date, version number). In the event of self-training only the trainee dates and signs the document
By signing the log the trainer confirms the training and the trainee confirms to have understood the content of the training.
Training-logs are filed in the ISF at the study site.
More
Study trainings include:
- The study protocol including scientific background, rationale and endpoint(s)
- The study design including any intervention and applicable randomisation procedures
- Handling, preparation and administration of IMP/MD
- Patient recruitment including screening and the informed consent process
- Organisation and conduct of study visits including all necessary medical examinations, laboratory tests, questionnaires and score evaluation
- Handling of biological material
- Safety reporting procedures including emergency and/or unblinding procedures
- Source data documentation
- Data entry in the study database
- Filing of study documents
- Study specific SOPs and WIs
Where can I get help?
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
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
- 2.8 Training
- 4.1.1, 5.6.1 Investigator qualification and training
ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections
- 9.2.1 Selection and training of clinical personnel
- 10.2 Qualification of PI
- 10.3 Qualification of investigational site
Swiss Law
HRA – see in particular article
- Art. 10 Professional qualifications
ClinO – see in particular article
- Art. 6 Professional qualifications
ClinO-MD – see in particular article
- Art. 5 Professional qualifications
HRO – see in particular article
- Art. 4 Professional qualifications