What is it? Why is it important?

Individuals involved in the conduct of a study must be qualified by education, training and experience (e.g. SP-INV, Site-INV, study nurse, laboratory staff, technician, project manager).

Training includes:

  • The study protocol
  • The informed consent process
  • Quality documents (e.g. study SOPs, WIs, processes)
  • Study relevant activities (e.g. data entry, IMP/MD handling, laboratory work, document filing)
  • ICH-GCP for ClinO studies

SP-INV and Site-INV are required to implement:

  • The Swiss Federal Act on Research Involving Human Beings (HRA), including its ordinances (ClinO, ClinO-MD, HRO)
  • Data protection laws
  • ISO 14155 for medical device studies
  • The Declaration of Helsinki

More

In order to follow and implement required guidelines and laws, it is required that all individuals involved in study planning, conduct and completion are properly and adequately trained. This guarantees:

  • Ongoing compliance with the study protocol during study conduct
  • Study participants safety and rights
  • The integrity and quality of study data

What do I need to do?

Ensure trainings are done:

  • By qualified trainer(s) or through self-training
  • On site, by phone or web-based
  • Both at study initiation and during study conduct
  • Prior to performing any delegated study tasks
  • After an amendments or changes to study relevant documents (e.g. study protocol, ICF, SOPs)
  • In the event of changes in study staff or delegated responsibilities

Include on the training document:

  • The training date (e.g. if applicable include the time)
  • Training means (e.g. face-to-face, self-training, web-based)
  • Name and function of trainer and trainee
  • Name of trained documents (e.g. include document identifier and version)

Upon training, the trainer and trainee date and sign the training log. By signing, the trainee confirms to have been properly informed and trained or has read and understood the content of the trained documents.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guideline

  • 2.8 Training of Individuals in Trial

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

  • 8.2.1 g) Training of involved parties

Declaration of Helsinki – see in particular principle

  • 12 Qualifications

Swiss Law

ClinO – see in particular article

  • Art. 6 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
Abbreviations
  • ClinO - Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • HRO - Human Research Ordinance
  • ICF – Informed consent form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • WI – Working Instruction
Basic ↦ Documents ↦ Staff Documents ↦ Training
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): Basic ↦ Documents ↦ Staff Documents ↦ Training

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