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.


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 CTU can support you with experienced staff regarding this topic

External Links

Swissethics – see in particular

  • 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 (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
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • HRA – Human Research Ordinance
  • HRO – Human Research Ordinance
  • ICH-GCP – International Council for Harmonisation Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • SOP – Standard Operating Procedures
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Set-Up ↦ Management ↦ Study Training ↦ Staff Delegation

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Set-Up ↦ Management ↦ Study Training ↦ Staff Delegation

Please note: the Easy-GCS tool is currently under construction.