What is it? Why is it important?

A study protocol describes a planned study and the set of rules that must be complied with during study conduct. Thus, in order to ensure protocol compliance all involved study staff and potential partners must be trained on the study protocol.

 

Training of study staff / partners

Usually the study SP-INV, or a study monitor / CRO performs the protocol training. Training is often combined with a study-site initiation visit, which can include additional documents referred to in the study protocol (e.g. safety reporting SOP, informed consent process, laboratory manual, handling or administration of IMD/IMD, handling of biological material)

 

Training of study participants

Study participants are not trained on the study protocol, but are informed about the study through separate documents destined for participants (i.e. Participant Information Sheet (PIS) and Informed Consent Form (ICF)). These documents describe the study and the participant`s responsibilities. Once informed, only study participants signing the ICF are recruited for the study.

More

Important protocol chapters to train include:

What do I need to do?

As a SP-INV, ensure involved study staff and potential partners are trained on the protocol, such as:

  • A study statistician responsible for data analysis
  • The Site-INV(s) in a multicentre study responsible for a given study site
  • Other relevant collaborators (e.g. laboratories, monitoring institutions). Training can be adapted based on a collaborator`s responsibilities

 

As a Site-INV, ensure:

  • Site staff is trained on the study protocol, prior to implementing delegated study tasks
  • Delegated study tasks are executed as defined in the protocol (e.g. informed consent process, safety reporting, handling and administration of IMP/IMD, participant safety and rights). Even if delegated to site staff, final responsibilities remain with the Site-INV
  • Protocol issues are promptly communicated to the SP-INV (e.g. protocol deviations, protocol amendment)

 

Protocol trainings and the training of study participants must be documented (e.g. patient file, signing of the ICF).

 

Once trained the study-site can start to recruit study participants.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Templates / Checklists / “Flowchart to assist with the use of the template”
  • Templates / Checklists / Study protocols / Requirement for study protocols according to HRA

References

Abbreviations
  • CAPA – Corrective and Preventive Action
  • CRO – Contract Research Organistion
  • CTU – Clinical Trials Unit
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation Good -Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO – International Organization for Standardization
  • PIS – Participant Information Sheet
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor
Set-Up ↦ Protocol ↦ Protocol Training ↦ Requirements
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

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
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device
Completion

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 ↦ Protocol ↦ Protocol Training ↦ Requirements

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