What is it? Why is it important?

Study compliance is important in order to ensure the safety of study participants and the quality of study data. Compliance by both researchers and participants have a significant effect on the outcome of the study.


For a SP-INV and Site-INV compliance means the adherence to:


For participants compliance means the adherence to:

  • Study procedures as described in the PIS/ICF ((e.g. to attend planned study visits, intake and use of IMP/IMD, provision of biological material)
  • The correct intake or use of the Investigational Product (e.g. IMP/IMD)
  • The provision of study required data (e.g. medical examinations, questionnaires, biological material)


Non-compliance should automatically trigger a route cause analysis and the implementation of risk control-measures.

What do I need to do?

As a SP-INV and Site-INV know the risks and consequences of non-adherence, as it can seriously jeopardize the study by endangering the:


In addition, non-compliance might signify non-adherence to ethics and regulatory requirements (e.g. Swissmedic) with potential serious consequences to the study and researchers.


As a Site-INV:

  • Ensure that both staff and study participants are adequately trained on study requirements and processes (e.g. treatment specifications, dose escalations, safety reporting)
  • Schedule regular staff meetings to evaluate compliance, and train staff as applicable


In the event of protocol non-compliance:

  • Document non-compliance in a deviation-log
  • Provide reasons for breach including corrective and preventative measures (CAPA) to avoid re-occurrence. Events for which compliance is difficult or not possible might trigger a protocol amendment

Where can I get help?

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


ICH GCP E6(R2) – see in particular guidelines

  • 2.6 Compliance with EC/RA approved protocol
  • 4.5 Compliance with protocol
  • 5.6.3 Site-INV compliance agreement
  • 5.18.0 Purpose of monitoring
  • 5.20 Non-compliance
  • 6.2.5 Background information and compliance


ISO 14155:2020 Medical devices (access liable to cost) - see in particular section

  • 10.6 Compliance with the CIP

Swiss Law

ClinO – see in particular article

  • Art. 6. Professional qualifications and compliance

ClinO-MD see in particular article

  • Art. 4 General obligations of the sponsor and investigator

HRO – see in particular article

  • Art. 4. Professional qualifications and compliance
  • ClinO - Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CIP – Clinical Investigational Plan
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • PIS – Patient Information Sheet
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • WI – Working Instructions
  • SP-INV – Sponsor-Investigator
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Compliance

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 ↦ Management ↦ Responsibility and Oversight ↦ Compliance

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