Your Easy Guide to Clinical Studies

Training of study documents or records is essential to ensure the study is:

• Correctly and consistently implemented
• Compliant with ethics and regulatory requirements (e.g. Swiss Laws, ICH GCP, ISO 14155, ISO 29016)

 

Training of study documents / records ensure:

• Study protocol compliance – staff understand study objectives and required procedures (e.g. target population, study outcome/endpoint, study eligibility criteria, visit planner)
• Participant safety and rights – staff comply with the informed consent process, safety assessment and reporting, respect patient rights (e.g. study withdrawal, right to information)
• Data quality – staff understand the importance of preventing data errors and missing data (e.g. consistent and correct data collection and entry procedures)
• Compliance with delegated roles and responsibilities – staff understand assigned tasks and responsibilities
• Compliance with risk management procedures – staff retain oversight of the study's Critical to Quality factors and implement required risk-control measures, including the documentation of new risks
• Compliance with ethics and regulatory requirements – staff are knowledgeable about ethics principles, regulatory requirements, and guidelines.

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As a SP-INV and Site-INV, ensure:

• All trainings is documented. Only dated and signed training documents/records, provide proof of staff trainings.
• 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
  • Before performing delegated study tasks, or due to changes in delegated responsibilities
  • After an amendment or changes to study relevant documents/records (e.g. protocol amendment, ICF, SOPs)

 

A training document or log should include:

• 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)
• Date and signature of both trainer and trainees

 

File training logs in the Investigator Site File (ISF) of the respective study site, or Trial Master File (TMF) for SP-INV training.

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References

ICH GCP E6(R3) – see in particular guidelines

• Appendix C. Essential records for the conduct of a clinical trial
• 3.16.3 Record keeping and retention
• 2.1 Investigator qualifications and training
• 3.4 Sponsor qualification and training

ISO 14155:2026 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

ClinO-MD – see in particular

• Art. 5 Professional qualifications

HRO – see in particular article

• Art. 4 Professional qualifications