Your Easy Guide to Clinical Studies

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 to adhere:

• The Ethics Committee (EC) and, if applicable, Swissmedic / FOPH approved study protocol (e.g. study design, safety reporting)
• Applicable laws (e.g. Swiss laws, international)
• Principles of ethics and applicable guidelines (e.g. ICH-GCP, ISO 14155 , ISO 209106)
• Study relevant SOPs and WIs (e.g. informed consent process)

 

For participants compliance means the adherence to:

• Study procedures as described in the PIS/ICF ((e.g. to attend planned study visits, the provision of health-related personal data and biological material)
• The correct intake and/or use of the study`s Investigational Product (e.g. IMP / IMD)
• To fulfil additional required study tasks (e.g. collaborations during medical assessments, the completion of study questionnaires / participant diaries)

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

• Right and safety (risk-benefit ratio) of study participants
• Quality of the study data
• Credibility of obtained study results (e.g. endpoint/outcome)
• Ability to answer the research question

 

Non-compliance should trigger:

• A root cause analysis
• The implementation of Corrective and Preventive Actions (CAPA)
• The documentation of reasons for non-compliance, including its CAPAs

 

As a SP-INV:

• Ensure the risk-based quality management system remains active during study conduct
• Increase study monitoring in the event of site non-compliance issues
• Consider a protocol amendment for CAPA unresponsive non-compliances

 

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

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References

ICH GCP E6(R3) – see in particular guidelines

• II. Principles of ICH GCP – 3.1 Compliance with EC/RA approved protocol
• 2.5 Compliance with Protocol
• 3.6 3 Site-INV compliance agreement
• 3.11.4 Purpose of monitoring
• 3.12 Noncompliance
• B.2.5 Background information and compliance

ICH E8(R1) – see in particular guideline

• 6.1.1 Protocol Adherence

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

• 10.6 Compliance with the CIP

Swiss Law

HRA – see in particular article

• Art. 3f Definition: Health-related personal data

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