Set-Up↦Protocol↦Protocol Training↦Requirements
What is it? Why is it important?
A study protocol describes a planned study and the set of rules that must be complied with during study conduct. Thus, in order to ensure protocol compliance all involved study staff and potential partners must be trained on the study protocol.
Training of study staff / partners
Usually a study monitor performs the protocol training. Training is often combined with a study-site initiation visit, which can include additional documents referred to in the study protocol (e.g. safety reporting SOP, informed consent process, laboratory manual, handling or administration of IMD/IMD, handling of biological material)
Training of study participants
Study participants are not trained on the study protocol, but are informed about the study through separate documents destined for participants (i.e. Participant Information Sheet (PIS) and Informed Consent Form (ICF)). These documents describe the study and the participant`s responsibilities. Once informed, only study participants signing the ICF are recruited for the study.
More
Important protocol chapters to train include:
- The background and rational of the study
- The research question
- The categorisation of the study including respective laws (e.g. Swiss law) and guidelines (e.g. ICH GCP, ISO14155, ISO 20916)
- The study population including inclusion / exclusion criteria, and the informed consent process
- The study outcome(s) / endpoint(s)
- The study design (e.g. placebo controlled, blinded study)
- The handling and administration of the investigational product (i.e. IMP/IMD)
- Safety reporting procedures
- Data confidentiality
- Data collection and documentation (e.g. management of the study database)
- Quality assurance (e.g. monitoring, risk management, CAPAs)
What do I need to do?
As a SP-INV, ensure involved study staff and potential partners are trained on the protocol, such as:
- A study statistician responsible for data analysis
- The Site-INV(s) in a multicentre study responsible for a given study site
- Other relevant collaborators (e.g. laboratories, monitoring institutions). Training can be adapted based on a collaborator`s responsibilities
As a Site-INV, ensure:
- Site staff is trained on the study protocol, prior to implementing delegated study tasks
- Delegated study tasks are executed as defined in the protocol (e.g. informed consent process, safety reporting, handling and administration of IMP/IMD, participant safety and rights). Even if delegated to site staff, final responsibilities remain with the Site-INV
- Protocol issues are promptly communicated to the SP-INV (e.g. protocol deviations, protocol amendment)
Protocol trainings and the training of study participants must be documented (e.g. patient file, signing of the ICF).
Once trained the study-site can start to recruit study participants.
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
- Templates / Checklists / “Flowchart to assist with the use of the template”
- Templates / Checklists / Study protocols / Requirement for study protocols according to HRA