What is it? Why is it important?

The Site-INV is responsible to maintain study oversight at all times during study conduct. Ongoing oversight ensures that any delegated study tasks by the Site-INV are correctly executed. The aim is to protect study participants and guarantee the ongoing quality of study data.

Oversight ensures ongoing:

  • Study protocol compliance
  • Documentation of study participant recruitment status
  • Availability of infrastructure and material
  • Accurate IMP/MD storage and access
  • Presence of qualified and trained study staff
  • Adherence to pre-defined study procedures
  • Correct execution of study tasks
  • Participant safety and medical care
  • Quality of study data
  • Submission of annual safety reports

More

During study conduct, the Site-INV is responsible to:

  • Implement the study according to the current study protocol, GCP and applicable laws
  • Recruit participants, provide applicable information and sign the ICF
  • Ensure ongoing recruitment of study participant proceeds according to timeline
  • Protect the rights, safety and well-being of study participants
  • Ensure study design and randomisation procedures are correctly followed
  • Guarantee the quality and integrity of study results collected at the study site
  • Follow and ensure risk mitigating measures are implemented and effective
  • Forward safety issues to the SP-INV within required timelines
  • Handle IMP/MD according to SP-INV specifications
  • Manage study document with ongoing filing of essential document (e.g. ISF)
  • Supervise delegated study-related tasks

The Site-INV can delegate study tasks to applicable staff. However, overall study responsibility remains with the Site-INV.

What do I need to do?

To ensure oversight, plan and execute regular meetings with your study team to discuss:

  • Study progress and recruitment
  • Evaluation and efficacy of implemented risk procedures
  • Resolution of current / recurring issues and problems including improvement measures
  • Shift and reassessment of staff responsibilities
  • Applicable training of study SOPs, WIs, study relevant processes
  • Document management and ISF filing

Document the meeting and decisions taken in an applicable meeting protocol.

For more information refer to Quality and Risk in this Study Guide.

More

During meetings, problems can be identified early on, allowing for the implementation of preventive measures and thus avoid unnecessary delays.

The meeting protocol provides:

  • Resolution of pending issues
  • Decision regarding study processes and management
  • Transparency and reference tool for absentees
  • Evidence of study oversight in the event of an inspection by RA

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 4.2.5 Supervision of delegated tasks
  • 4.2.6 Qualification of delegated tasks
  • 4.5 Protocol compliance
  • 4.11 Safety reporting

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

  • 10 Responsibilities of the principle investigator

Swiss Law

ClinO – see in particular article

  • Art. 5. Rules of good clinical practice
Abbreviations
  • CTU – Clinical Trials Unit
  • IMP/MD – Investigational Site File / Medical Device
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ICF – Informed Consent Form
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Site-Investigator
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Management ↦ Responsibility and Oversight ↦ Site-Investigator

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