Your Easy Guide to Clinical Studies

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.

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

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. 4 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