What is it? Why is it important?

In (clinical) studies human volunteers (e.g. healthy persons or patients) are recruited with the aim to add new insight to medical knowledge. Studies can roughly be divided into interventional- and observational studies.

The collection of safety data is an essential and critical part, with the aim to:

  • Gather safety data in order to protect study participants from unnecessary risks
  • Detect relevant safety signals
  • Contribute to the ongoing development of the product`s safety profile (e.g. medically relevant information)
  • Provide support regarding the risk-benefit assessment of a planned study

The collection of safety data during study conduct / follow-up:

  • Starts at the time when the participant signs the ICF, except if otherwise specified in the study protocol
  • Ends after the last patient has completed his / her last study visit, or based on a pre-defined follow-up period (e.g. in the study protocol)

What do I need to do?

As a SP-INV and Site-INV:

  • Know the laws and regulations that address the safety management of studies (e.g. HRA, GCP, Declaration of Helsinki)
  • Based on your study, consult the reference documents that provide up-to-date safety information (e.g. IB for IMP/IMD, instruction for use for MDs, product information for MPs)
  • Define how to collect safety data (e.g. safety forms, study database / eCRF)
  • Define procedures on how to assess and report safety events during study conduct (e.g. in SOP and WIs)
  • Describe safety procedures in your study protocol
  • If required, set-up a study safety management plan and establish a Data Safety Monitoring Board (DSMB) (e.g. provides support on safety issues)
  • Assess safety data on an ongoing basis during study conduct in order to re-evaluate the risk-benefit ratio of the study (e.g. must remain favourable / benefits must outweigh risks)

More

As a SP-INV manufacturing new IMPs or IMDs:

  • Write and regularly up-date the IB section of your product (IMP or IMD), and describe the collected clinical data

Where can I get help?

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

References

ICH GCP E6(R2) – see in particular guideline

  • 2 The principles of ICH GCP

ISO 14155:2020 Medical device (access liable to costs) – see in particular section

  • 4 GCP principles

ISO 20916:2019 In vitro diagnostic medical device (access liable to costs) – see in particular

  • Good study practice

Declaration of Helsinki – see in particular

  • Risks, Burdens and Benefits

Swiss Law

FEDLEX – law is available online under number

  • 810.30 HRA

HRA – see in particular articles

  • Art. 4 Primacy of individual interests
  • Art. 11-14 Protection of participants
  • Art. 15 Safety and protective measures
Abbreviations
  • CTU – Clinical Trials Unit
  • DSMB – Data Safety Monitoring Board
  • eCRF – electronic Case Report Form
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • IB – Investigator`s Brochure
  • IMD – Investigational Medical Device
  • IMP – Investigation medicinal Product
  • ISO – International Organization for Standardization
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • MD – Medical Device
  • MP – Medicinal Product
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Basic ↦ Safety ↦ Safety Data ↦ In Clinical Studies
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): Basic ↦ Safety ↦ Safety Data ↦ In Clinical Studies

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