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.

More

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?

More

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

External Links

Swissethics – in particular see

  • 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 - 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

Swiss Law

ClinO – see in particular article

  • Art. 6 Professional qualifications

HRA – see in particular article

  • Art. 4 Professional qualifications
Abbreviations
  • CTU – Clinical Trials Unit
  • IMP/MD - Investigational Medicinal Product / Medical Device
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Set-Up ↦ Management ↦ Study Training ↦ Staff
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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