Your Easy Guide to Clinical Studies

Study personnel involved in the planning, conduct, and completion of a study, must be adequality trained on:

• Relevant guidelines (e.g. ICH GCP, ISO 14155, ISO 20916), the law (e.g. Swiss law), including ethics (EC) and regulatory (e.g. Swissmedic) requirements
• Study relevant documents/records such as:
  • The study protocol
  • The informed consent process
  • Quality documents (e.g. study SOPs, WIs, processes)
  • Study relevant activities (e.g. data entry, IMP / IMD handling, laboratory work, handling of Biological material, filing of document/records)

 

The aim of training is to ensure that the:

• Safety and rights of study participants are protected
• Integrity and quality of study data is guaranteed

 

Only by providing dated and signed training documents/records, can it be proven that study staff has been properly trained.

As a SP-INV and Site-INV, 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 delegated responsibilities

 

Include on the training document/record:

• 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/records (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.

References

ICH GCP E6(R3) – see in particular guideline

• 5.1 Staff qualification and training

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

ClinO-MD - see in particular

• Art. 5 Professional qualifications

HRO – see in particular article

• Art. 4 Professional qualifications