What is it? Why is it important?

The Investigator’s Brochure (IB) is a critically important document in drug development. It provides for any drug (IMP) under investigation a comprehensive summary of currently available results obtained from:

  • Pre-clinical studies (e.g. in vitro analysis, animal experiments)
  • Drug (IMP) studies in humans

The IB summarises clinical (and non-clinical) data, such as:

  • Drug dosing results, including dosing frequency and intervals
  • Method(s) of administration
  • Safety information (e.g. based on the ongoing monitoring and occurrence of AEs and ADRs), including applicable treatments
  • Preventative measures and precautionary procedures, which provide insight to the clinical management of study participants
  • Additional warning signs

The IB is continuously updated as new information becomes available during study conduct. This allows for ongoing adaptations of the IB in order to ensure participant safety and rights remain protected.

More

The IB provides important background information on the study drugs (IMP). As a result the IB can be used to plan for:

  • Expected safety concerns (e.g. AEs, ADR, safety risks)
  • A risk/benefit assessment of the planned treatment
  • The optimal method of administration (e.g. oral, injection, suppository)
  • The optimal drug dosing (e.g. drug escalation and tolerance levels, frequency of dosing intervals)

What do I need to do?

As a SP-INV you are responsible to:

  • Maintain ongoing full insight regarding the drug under investigation
  • Follow any relevant IB updates and consider potential safety adaptations during study conduct (e.g. reassessment of the study risk-benefit ratio)
  • Provide participating Site-INV(s) with IB information

As a Site-INV:

  • Read the chapter “Summary of data and guidance for the Investigator”
  • Based on this information, acquire current knowledge regarding drug safety risks and side effects, including the implementation of local preventative measures

The IB provides the SP-INV/Site-INV and other study involved staff with:

  • Information that facilitates their understanding with respect to the study rationale, including the required compliance with many key features of the study protocol

Where can I get help?

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

External Links

Swissmedic – see in particular

  • AW Working Instruction to “Clinical Trial Application Dossier” Section 6

References

ICH GCP E6(R2) – see in particular guideline

  • 7 Investigator’s Brochure
Abbreviations
  • ADR – Adverse Drug Reactions
  • AE – Adverse Event
  • CTU – Clinical Trials Unit
  • IB – Investigator’s Brochure
  • IMP – Investigational Medicinal Product
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Concept ↦ Documents ↦ Required Documents ↦ Investigator's Brochure
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): Concept ↦ Documents ↦ Required Documents ↦ Investigator's Brochure

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