What is it? Why is it important?

Apart from the study protocol, other study and reference documents provide study relevant safety information, such as the:

  • Patient Information Sheet (PIS) / Informed Consent Form (ICF): explain expected study risks to participants including the risk-benefit of the study
  • Case Report Form (CRF) / Study Database: where (serious) adverse reactions / events are documented in a standardised manner (e.g. either electronically or in paper form)
  • Product Information (PI): summarises all currently known safety information on marketed MPs
  • Instruction for use (IFU): summarises all currently known safety information on marketed MDs
  • Investigator Brochure (IB): summarises all currently known safety information on non-marketed products (e.g. IMP, IMD)
  • Monitoring plan: describes the risk-based monitoring strategy of the study (e.g. high risk studies require more extensive monitoring)

What do I need to do?

As a SP-INV ensure safety information and concerns are included in applicable study documents, such as:

  • PIS / ICF: include a list of foreseeable frequent AEs sorted by frequency. For infrequent ones include only serious ones
  • CRF: Irrespective whether in electronic or paper form (e.g. questionnaires), include sections for the documentation of safety events (e.g. AE / SAE / DD / SADE). Define whether SAE forms are available in electronic or paper form
  • Monitoring plan: adapt your monitoring strategy based on the risk assessment of your study (e.g. high risk requires more frequent monitoring visits)

Based on your study, describe the reference documents that apply to your study (e.g. IB for IMP/IMD, SmPC / PI for marketed MP, IFU for marketed MDs). The IB must be updated on a yearly basis (e.g. by the marketing holder of the therapeutic product)

More

If applicable, provide participants with an “in-case-of-emergency” card. Cards should include the participant’s name, study identifier, type of intervention, an emergency contact number, and the name of the Site-INV.

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
    • Study protocols
    • Patient information and consent

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.64 Monitoring plan
  • 5.18 Monitoring
Abbreviations
  • AE – Adverse Event
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • DD – Device Deficiency
  • IB – Investigator Brochure
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IFU – Instruction for Use
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • MD – Medical Device
  • MP – Medicinal Product
  • PIS – Patient Information Sheet
  • RSI – Reference Safety Information
  • SAE – Serious Adverse Event
  • SADE – Serious Adverse Device Effect
  • Site-INV – Site-Investigator
  • SmPC / PI – Summary of Product Characteristics / Product Information
  • SP-INV – Sponsor-Investigator
Development ↦ Safety ↦ Safety Documentation ↦ Study Documents
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): Development ↦ Safety ↦ Safety Documentation ↦ Study Documents

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