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:

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 (ClinO), ISO 14155 (medical device studies, ClinO-MD), 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. collection, processing, storage, analysis)
  • Ongoing participant safety monitoring and reporting to EC/RA (e.g. Swissmedic), 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

ClinO – see in particular articles

  • Art. 64-66 Registration
  • ASR – Annual Safety Report
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • 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

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Ethics and Laws ↦ Study Conduct ↦ Ongoing Tasks

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