What is it? Why is it important?

Quality documents are written verifiable records on study activities with the aim to build confidence in study results (e.g. accurate reporting, interpretation of results).


Quality Documents include:

  • Essential study documents
  • Supporting documents needed to support the quality of work, and which are 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 ICH 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 (e.g. Quality Assurance, Quality Control)
  • Provide written evidence that the study was conducted in compliance with the study protocol, the law (e.g. Swiss lawICH GCP, EC, applicable regulatory authorities (e.g. Swissmedic, FOPH), including other relevant guidelines (e.g. ISO 14155)


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


Example of essential documents:

What do I need to do?

As a SP-INV:

  • Define and make a list of quality documents applicable to your study. Iincluding Quality Assurance and Quality Control aspects. 
  • Develop applicable SOPs, WIs, and processes needed for Quality Assurance and risk control
  • Finalise those essential documents that must be submitted to the Ethics Committee (EC) and if applicable RA (e.g. Swissmedic) (e.g. study protocol, ICF, CRF, contracts, budget, insurance)
  • Start preparing other relevant quality documents (e.g. useful checklists showing work flow)
  • Include study team members as potential quality documents reviewers 
  • Train study staff regarding the understanding and application of quality documents


Site-INV responsibilities:

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


For more information refer to Documents in this Study Guide


In order to retrace study activities, essential documents are:

  • Reviewed by operational staff
  • Reviewed for accuracy and completeness by the study monitor during monitoring visits
  • Inspected by RA (e. g. Swissmedic) during study inspections in order to evaluate compliance with the study protocol, the safe conduct of the study such as safety reporting procedures, data collection and the quality of obtained data
  • Archived upon study termination for a defined period of time, depending on type of study, regulatory and local requirements

Where can I get help?

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


ICH GCP E6(R2) – see in particular guidelines

  • 5.1 Quality assurance and quality control
  • 8.0 Essential documents

ISO 9001: 2012 - see in particular section (access liable to costs)

  • Quality Management System


  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FOPH – Federal Office of Public Health
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ICF – Informed Consent Form
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO – International Organization for Standardization
  • 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

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

Starts with ethics and regulatory approval

Ends after successful study initiation

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

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

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.