Your Easy Guide to Clinical Studies

The Site-Investigator (Site-INV) is responsible to ensure the safety of study participant and the quality of study data at a particular study site.

 

During study conduct the Site-INV must:

• Implement risk-based quality management procedures as defined by the SP-INV
• Ensure that local quality requirements are in place (e.g. local SOPs, WIs, processes)
• Ensure that site staff is qualified and trained on the conduct of the study, and trained on risk management, including additional quality aspects (e.g. Quality Assurance, Quality Control)
• Inform the SP-INV regarding novel risk concerns, and propose local mitigating risk measures
• Maintain ongoing study oversight

 

The Site-INV can delegate tasks and QMS responsibilities to study staff. Still, the ultimate responsibility remains with the Site-INV, who ensures the qualification and training of study staff.

As a Site-INV familiarise yourself and comply with:

• The study protocol (e.g. from set-up to completion)
• Regulatory requirements (e.g. Swiss law) and applicable guidelines (e.g. ICH GCP, ISO 14155)
• Defined risk-management of the study
• Risk documentation requirements,
  • Risk reviews and documentation
  • Timely and correct filing of study documents (e.g. ISF)

 

During study conduct:

• Supervise the efficacy of implemented risk control measures, as they might have to be adapted in order remain effective
• Hold regular staff meetings, where study updates, issues, risk problems and solutions are discussed
• Document important decisions and proposed solutions (e.g. meeting minutes)
• Document delegated study tasks and responsibilities (e.g.  in a site delegation-log), and ensure staff is trained on QMS and risk management procedures

References

ICH GCP E6(R2) – see in particular guideline

• 1.34 Investigator
• 4. Investigator
• 5.0 Quality management

ISO 31000 (access liable to costs) – see in particular section

• Risk management

Documents

• Risk Assessment Form for Clinical Research Projects