Your Easy Guide to Clinical Studies

To guarantee the quality, safety, and reliability of study results, researchers must prove:

• Their compliance with the study protocol, including applicable added reequipments during study conduct
• The ongoing protections of participant safety and right
• The quality of collected and analysed study data

 

Tasks include but are not limited to the ongoing:

• Monitoring of data quality (e.g. monitoring visits)
• Correct handling of the therapeutic product (e.g. IMP / IMD), and Biological Material (e.g. sample workflow)
• Compliance with safety reporting requirements (e.g. safety reporting, safety risk review)
• Compliance with the study`s risk-based Quality Management System (QMS) (e.g. risk review, staff trainings)
• Communication with the Ethics Committee (EC) and Swissmedic (i.e. risk-category B & C studies), such as to:
  • Notify within 30 days the enrolment of the first patient in Switzerland
  • Notify the occurrence of safety events
  • Submit once a year a study progress report, which includes a safety assessment of the study

As a SP-INV and Site-INV, ensure that required compliance and quality aspects defined during study planning are maintained during study conduct, such as:

 

Compliance with the study protocol, including applicable:

• Ethical Committee (EC) requirements, and ethical principles
• Laws (Swiss law such as safety reporting requirements, ongoing registry updates)
• Guidelines (e.g. ICH GCP, ISO 14155, ISO 20916 Declaration of Helsinki)
• Quality processes (e.g. SOP, WI)

 

Evaluation of the study`s risk strategy, by assessing if:

• All “Critical to Quality” (CtoQ) factors, identified during study planning, were correctly identified
• Risks threatening CtoQ factors were correctly identified, evaluated & prioritized
• Implemented risk control-measures are both applicable and efficient
• The risk-benefit ratio of the study remains favourable (e.g. once a year)
• Study staff remains trained and vigilant regarding the management and implementation of the study`s risk-based QMS

 

Adaptations regarding the study`s risk-based and quality approach is well documented (e.g. TMF/ISF, Risk Assessment Form) to guarantee tracking and rational during study conduct.

External Links

Swissethics – see in particular

• Notification and reporting to the Ethics Committee
• Annual Safety Report

Swissmedic – see in particular

• BW101_20_002e_MB_Safety_of_Medicines.pdf

References

ICH GCP E6(R3) – see in particular

• 3.10 Quality Management

ICH E8(R1) – see in particular

• 3.1 Quality by Design of clinical studies
• 3.2 Critical to Quality Factors

Swiss Law

ClinO – see in particular articles

• Art. 38 Notification of the first visit
• Art. 43 Reporting on the safety of participants
• Art. 57 Transplant trials - notification for EC
• Art. 62 Other clinical studies - applicable provisions
• Art. 64 Registration
• Art. 67 Portal

CinO-MD – see in particular article

• 35 Reporting on the safety of participants to EC
• Art. 38 Reporting to Swissmedic