What is it? Why is it important?

Apart from participant recruitment, treatment and follow-up, many additional study tasks require ongoing attention.

These tasks include to:

  • Ensure the study is conducted in compliance with the study protocol, applicable laws and regulations
  • Review the implemented risk strategy of the study and the efficacy of its preventative measures
  • Monitor the ongoing quality of the study and its collected data (e.g. monitoring visits)
  • Ensure safety reporting requirements are correctly implemented
  • Perform a risk-benefit assessment of the study, preferably once a year
  • Ensure that staff remains trained on new and evolving tasks
  • For ClinO studies:
    • Notify Swissmedic of the first patient enrolled in Switzerland (e.g. applicable for category B & C studies)
    • Submit an Annual Safety Report (ASR) to EC, and if applicable Swissmedic
    • Perform annual updates on study applicable registries

What do I need to do?

As a SP-INV and Site-INV, ensure:

  • The study is conducted in compliance with the Swiss law, ICH GCP, and the Declaration of Helsinki
  • Informed consent procedures are correctly implemented and recorded (e.g. prior to any study relevant procedures, with special considerations regarding vulnerable participants such as children, participants without capacity, pregnant women)
  • Compliance with data protection laws
  • Surveillance and efficacy of the study`s implemented risk management
  • Correct handling of IMP/IMD (e.g. storage, application)
  • Correct handling of Biological Material (BM) (e.g. processing, storage, analysis)
  • Ongoing participant safety monitoring and reporting to EC/RA, including submission of an ASR
  • Annual updates in applicable study registries
  • Correct and current study documentation (e.g. data entry, TMF/ISF)

For more information refer to Study Management, Safety, and Quality & Risk in this study guide.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Notification and reporting to the Ethics Committee
  • Annual Safety Report

Swissmedic – see in particular

  • BW101_20_002e_MB_Safety_of_Medicines.pdf

Swiss Law

FEDLEX – law is available online under number

  • 810.305 ClinO

ClinO – see in particular articles

  • Art. 64-66 Registration
Abbreviations
  • ASR – Annual Safety Report
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FEDLEX – Publication Platform for Federal Laws
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Conduct ↦ Ethics and Laws ↦ Study Conduct ↦ Ongoing Tasks
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 ↦ Ethics and Laws ↦ Study Conduct ↦ Ongoing Tasks

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