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 the adherence to:

• The approved study protocol
• Ethics Committee (EC), and if applicable RA (e.g. Swissmedic) requirements
• Applicable laws (e.g. Swiss laws, international)
• Applicable guidelines (e.g. ICH-GCP for ClinO studies, ISO 14155 for ClinO-MD studies, ISO 209106 for IVD studies)
• 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, 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.

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:

• Safety of study participants
• Quality of the study data
• Credibility of obtained study results
• Reputation of researches

 

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

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 (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