What is it? Why is it important?

The quality of a study can be verified based on written verifiable records of performed study activities. Thanks to these records, the study can be retraced confirming the quality of the study. High quality studies provide confidence in the obtained study results (e.g. accurate and non-biased interpretation and reporting of study results).


Verifiable quality records include:

  • Essential documents: are the operational documents of the study and provide written evidence that:
  • Study specific documents: are documents that facilitate and standardise study tasks to ensure these are harmonised, (e.g. guidelines, checklists, memos)
  • Supporting ducuments: are documents that ensure the quality of work processes. They are also used outside the study (e.g. local directives such as emergency processes by freezer failure)



Essential documents:

  • Are defined in chapter 8 of ICH GCP
  • Are filed in the TMF/ISF of the study


Requirement and extent of collected quality records 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. Include Quality Assurance and Quality Control aspects (e.g. develop applicable SOPs and WIs defining quality processes)
  • Finalise the essential documents required for your study  (e.g. study protocol, ICF, CRF, contracts, budget, insurance). Essential documents are submitted to EC and if applicable RA (e.g. Swissmedic) for approval
  • Start to prepare study specific supporting quality documents (e.g. useful checklists showing work flow)
  • Include study team members as potential reviewers of quality documents (e.g. is implementable, is understandable)
  • Train study staff on the implementation 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 checklists to be approved by the SP-INV.
  • Ensure that the filing of essential documents are complete, up-to-date, and if applicable signed and dated (e.g. in the ISF)
  • Ensure quality documents are trained and ready to be implemented by study staff


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) (access liable to costs) – see in particular guidelines

  • 5.1 Quality assurance and quality control
  • 8.0 Essential documents

ISO 9001: 2012 - see in particular section

  • Quality Management System


  • ClinO – Clinical Trials Ordinance
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • CV – Curriculum Vita
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FOPH – Federal Office of Public Health
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ICF – Informed Consent Form
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • QA – Quality Assurance
  • 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 ↦ Verification

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Quality and Risk ↦ Quality Assurance ↦ Verification

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