What is it? Why is it important?

During study conduct, SP-INV and Site-INV are responsible to maintain study oversight at all times. This is achieved through the ongoing documentation and update of study activities.

Study activities can be tracked in the following documents:

  • PIS and ICF: inclusion of study participants
  • Study logs: delegation of study responsibilities, inclusion of participants, etc.
  • p/eCRF: documentation of collected study data
  • Protocol Deviation: documentation of deviations to the study protocol
  • Monitoring report: documentation of study compliance
  • SAE and SUSAR forms: safety documentation
  • Protocol: documentation of study management
  • Amendment: documentation of changes to the study protocol, ICF, PIS, IB, etc.
  • Staff trainings: competencies, responsibilities,
  • IMP/MD handling: orders, inventory, shipments, storage conditions
  • Communication: with partners, participants, study sites
  • ASR: yearly safety documentation

More

An ongoing oversight and documentation of study activities ensure that study tasks remain correctly implemented, and that participant safety and data quality is guaranteed.

The SP-INV and Site-INV can delegate study tasks to qualified staff. However, overall study responsibility remains with the SP-INV and Site-INV, respectively.

What do I need to do?

As a SP-INV or Site-INV:

  • Check that study documentation is correct and current
  • Regularly review the TMF or ISF to ensure all essential documents are filed
  • Ensure data entry into the study CRF (e.g. CDMS) is done without delay
  • Ensure monitoring findings that address documentation issues are quickly resolved
  • Restrict the access to study documents to applicable study staff

As a SP-INV, you are responsible to implement a risk-based QMS. Within this context, various quality documents are implemented in the study (e.g. SOPs, WIs, processes). Ensure quality documents remain current during study conduct. As required, perform quality reviews and implement improvement measures.

A good way to retain study quality and oversight is to plan regular team meetings, where problems can be identified early on and corrective measures can be discussed.

More

Document the meeting in a protocol and include:

  • Identified problems or issues
  • The implementation of corrective and or preventative measures, and the resolution of pending issues
  • Adaptations regarding study processes and management

Documented protocol meetings:

  • Are important reference documents for study staff, including meeting absentees
  • Provide good evidence of study oversight in the event of an audit or inspection by RA (e.g. Swissmedic)

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
  • 8.3 During the Clinical Conduct of the Trial

ISO 14155:2020 Medical devices - see in particular section (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
  • ASR – Annual Safety Report
  • CDMS - Clinical Data Management System
  • CRF – Case Report Form (p – paper; e – electronic)
  • CTU – Clinical Trials Unit
  • CV – Curriculum Vitae
  • IB – Investigator’s Brochure
  • ICF – Informed Consent Form
  • IMP/MD – Investigational Medicinal Product
  • PIS – Participant Information Form
  • QMS – Quality Management System
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SAE – Serious Adverse Event
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • SUSAR – Suspected Unexpected Serious Adverse Reaction
  • WI – Working Instruction
Conduct ↦ Documents ↦ Required Documents ↦ Study Documentation
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 ↦ Documents ↦ Required Documents ↦ Study Documentation

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