Conduct↦Management↦Responsibility and Oversight↦Compliance
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
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?
- 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:
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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
ClinO – see in particular article
- Art. 6. Professional qualifications and compliance
HRO – see in particular article
- Art. 4. Professional qualifications and compliance