What is it? Why is it important?

Quality documents are written verifiable records on study activities building confidence in study results (e.g. accurate reporting, interpretation of results).

Quality Documents include:

  • Essential study documents
  • Supporting documents needed to support quality of work and also used outside the study, (e.g. local directives such as emergency processes by freezer failure)
  • Non-essential study documents that facilitate daily work, (e.g. checklists, memos)

Essential documents:

  • Are defined in chapter 8 of GCP
  • Are operational documents that allow study activities to be retraced
  • Play a key role in successful study management
  • Are filed in the TMF/ISF of the study
  • Provide written evidence on implemented quality measures, and that the study was conducted in compliance with the study protocol and GCP

More

 

Example of essential documents:

  • Study protocol
  • Participant information & Consent
  • Case report forms
  • Standard Operating Procedures (SOP)
  • Working Insructions (WI)
  • Logs (e.g. participant enrolment, identification, IMP/MD inventory and dispensing)
  • Staff qualiification (e.g. CV, study trainings, further education)
  • Certificate (e.g. GCP, laboratorires, service providers)
  • IMP handling instructions
  • Labels, shipping records
  • Laboratories accreditations
  • Biobank certification
  • etc

In order to retrace study activities, essential documents are:

  • Reviewed for accuracy and completeness by the study monitor during monitoring visits
  • Inspected by EC/RA during study inspections in order to evaluate compliance with protocol and safety procedures including quality of obtained study data
  • Archived upon study termination for a defined period of time, depending on type of study and local requirements

What do I need to do?

  • Define which quality documents are applicable to your study
  • Finalise those essential documents that must be submitted to EC/RA (e.g. study protocol, IC, CRF, contracts, budget, insurance)
  • Start preparing other relevant quality documents (e.g. useful checklists showing work flow)
  • Develop applicable SOPs, WIs and processes needed for quality assurance and risk control
  • Include study team members as potential reviewers

For more information refer to Documents in this Study Guide

More

Site-INV responsibilities:

  • Implement quality documents provided by the study SP-INV
  • If needed, define and write local SOPs, worksheets and logs to be approved by the SP-INV.
  • Ensure that essential documents such as logs (e.g. delegation-, medication log) are complete, updated and signed

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

  • 5.1 Quality assurance and quality control
  • 8.0 Essential documents

Documents

Abbreviations
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • GCP – Good Clinical Practice
  • IC – Informed Consent
  • IMP – Investigational Medicinal Product
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • TMF/ISF – Trial Master File / Investigator Site File
  • WI – Working Instruction
Development ↦ Quality and Risk ↦ Quality Assurance ↦ Quality 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): Development ↦ Quality and Risk ↦ Quality Assurance ↦ Quality Documents

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