What is it? Why is it important?

Compliance is important in order to ensure the quality of study data and consequently study outcome, including the safety of study participant.

Compliance addresses requirement that:

  • SP-INV, Site-INV and study staff must comply with the study protocol, GCP, laws, including study applicable SOPs, WIs and processes
  • Participants must comply with study procedures as described in the PIS/ICF
  • Non-compliance should automatically trigger a route cause analysis and a re-evaluation of its risk strategy and processes
  • Any non-compliance must be documented in a deviation log

More

In the event of protocol non-compliance:

  • Document non-compliance in a deviation log
  • Provide reasons for breach including corrective measures to prevent re-occurrence of non-compliance
  • Ensure both staff and if applicable participants are trained on processes to ensure compliance

What do I need to do?

Regularly evaluate:

  • Site (site-INV, study staff) compliance with the study protocol, quality processes, including mitigating risk control measures
  • Participant compliance with study procedures (e.g. treatment specifications, dose escalation, safety reporting)

Non-compliance can seriously jeopardize the study and endanger the:

  • Integrity of your study
  • Quality of your data
  • Safety of study participants

As a Site-INV / Sp-INV schedule regular staff meetings to evaluate compliance, and train staff as applicable. Events for which compliance is difficult or not possible might trigger a protocol amendment.

For more information refer to Quality and Risk in this Study Guide.

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 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 - see in particular sections (access liable to cost)

  • 10.6 Compliance with the CIP

Swiss Law

ClinO – see in particular article

  • Art. 6. Professional qualifications and compliance

HRO – see in particular article

  • Art. 4. Professional qualifications and compliance
Abbreviations
  • CIP – Clinical Investigational Plan
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • PIS/ICF - Patient Information Sheet / Informed Consent Form
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • WI – Working Instructions
  • SP-INV – Sponsor-Investigator
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Compliance
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 ↦ Management ↦ Responsibility and Oversight ↦ Compliance

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