What is it? Why is it important?
All staff members involved in study set-up and implementation must be properly trained on their respective tasks. Training requirements depend on individual responsibilities.
Staff training must be:
- Done by a qualified trainer or through self-training
- Face to face, by telephone or other applicable mean
- Both at study initiation and during study conduct
- Prior to performing any study delegated tasks
- Upon changes in study relevant documents
All trainings must be documented on a training log either as face-to-face training or performed as 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 and signature of trainer and trainee. 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. The training logs is filed in the ISF of the study site.
What do I need to do?
Based on your study, decide:
- 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 the training log, always refer to type of document or tool trained (e.g. name, date, version number).
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 and storage 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 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
Swissethics – in particular see
- Information on professional qualifications
- List of persons conducting a study
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 - see in particular sections (access liable to cost)
- 9.2.1 Selection and training of clinical personnel
- 10.2 Qualification of PI
- 10.3 Qualification of investigational site
ClinO – see in particular article
- Art. 6 Professional qualifications
HRA – see in particular article
- Art. 4 Professional qualifications