What is it? Why is it important?

An Adverse Drug Reaction (ADR) is an AE that has a causal relationship with the Investigational Medicinal Product (IMP) under investigation.

An ADR is any noxious and unintended response to a drug and which occurs:

  • At any dose during Phase I-III studies (e.g. studies testing newly developed IMPs, or licensed MPs not used as approved)
  • At doses normally used and approved during studies with a licensed MP (e.g. used as approved)

An ADR is considered serious (SADR) if the event:

  • Results in death
  • Is life-threatening
  • Requires in-patient hospitalization or prolongation of existing hospitalisation
  • Results in persistent or significant disability/incapacity, or
  • Is a congenital anomaly / birth defect

The WHO defines a MP or drug as:

Any substance (other than food) that is used to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition.

What do I need to do?

As a Site-INV:

  • In the event of a serious ADR (SADR) follow same reporting procedures as described for SAE

As a SP-INV:

  • Follow SAE reporting procedures
  • In the event of an unexpected SADR (e.g. based on the RSI: IB for non-licensed IMPs, product information for licensed MPs), follow reporting procedures described for SUSAR
  • For category A studies, report all SADRs to Swissmedic within 15 days (e.g. through the Pharmacovigilance (PV) drug safety department, or the PV unit at your hospital)
  • For first pilot phase TrP / GT / GMO studies, report all SADR to Swissmedic within 15 days

Documentation and reporting starts and is mandatory once the participant has signed the ICF until:

  • Study termination (e.g. last study participant at last study visit), or
  • The end of some predefined safety follow-up period (e.g. as defined in the study protocol)

Where can I get help?

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

External Links

Swissethics – see in particular

  • Templates and checklists / Notification
    • SAE medicinal products

Swissmedic – see in particular information sheet

  • BM101_10_002e_MB FAQ on clinical trials with medicinal products

References

ICH GCP E2A – see in particular guidelines

  • Chapter II Definition

ICH GCP E6(R2) – see in particular guidelines

  • 1.1 ADR definition
  • 1.50 Serious ADR definition
  • 1.60 Unexpected ADR
  • 5.17 ADR reporting
  • 7.3.7 Summary of data and guidance for the investigator

Swiss Law

FEDLEX – law is available online under number

  • 810.30 HRA
Abbreviations
  • ADR – Adverse Drug Reaction
  • AE – Adverse Event
  • CTU – Clinical Trials Unit
  • FAQ – Frequently Asked Questions
  • FEDLEX – Publication Platform for Federal Laws
  • IB – Investigator`s Brochure
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ICF – Informed Consent Form
  • IMP – Investigational Medicinal Product
  • MP – Medical Product
  • PV – Pharmacovigilance
  • RSI – Reference Safety Information
  • SADR – Serious Adverse Drug Reaction
  • SAE – Serious Adverse Event
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • SUSAR – Suspected Unexpected Serious Adverse Reaction
  • TPA - Therapeutic Product Act
  • WHO – World Health Organisation
Conduct ↦ Safety ↦ Medicinal Product Safety Reporting ↦ (Serious) Adverse Drug Reaction
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): Conduct ↦ Safety ↦ Medicinal Product Safety Reporting ↦ (Serious) Adverse Drug Reaction

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