What is it? Why is it important?

Study quality documents (QD) enable operational staff, monitors, auditors and inspectors to evaluate compliance with the study protocol, the safe conduct of the study, and the quality of obtained data.

Preparation of QD start during the development phase and must be finalised and implemented before the SIV.

Requirement and extent of collected quality documents depend on identified risks, their prioritisation and control measures, including study type (ClinO, HRO) and risk category (A, B, C).

More

Example of quality documents:

  • Study protocol
  • Participant information & Consent
  • Standard Operating procedures (SOPs)
  • Worksheets (WI)
  • Logs (e.g. participant enrolment, identification, IMP/MD inventory and dispensing, staff trainings)
  • Certificates (e.g. laboratories, service providers)
  • Staff qualification (e.g. CV, further education)

What do I need to do?

  • Make a list of QD needed for your study and make applicable adaptations when using previously implemented QDs
  • Submit applicable QD to the EC/RA for approval and make modification as requested (e.g. study protocol)
  • Distribute and train staff regarding the understanding and application of QD

As Site-INV:

  • Implement revised documents provided by SP-INV. This might require feedbacks and signatures
  • If needed, modify local SOPs, WIs and Logs needed for the study

For more information refer to Monitoring and Documents in this Study Guide

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

  • 5.0 Quality management
  • 5.2.2 Addendum: Sponsor oversight

ISO 9001:2015 – see in particular section

  • Quality Management Systems (access liable to costs)

Documents

Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • CV – curriculum Vita
  • EC/RA – Ethics Committee / Regulatory Authorities
  • HRO – Human Research Ordinance
  • IMP/MD – Investigational Medicinal Product / Medicinal Device
  • QD – Quality Documents
  • Site-INV – Site Investigator
  • SIV – Site Initiation Visit
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Set-Up ↦ Quality and Risk ↦ Documentation ↦ Quality and Study Documents
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): Set-Up ↦ Quality and Risk ↦ Documentation ↦ Quality and Study Documents

Please note: the Easy-GCS tool is currently under construction.