What is it? Why is it important?

Are documented activities and trainings needed to verify the feasibility of planned study processes, and ensure that performance does not deviate and is executed in a consistent and homogeneous manner.

Verified and approved processes ensure that procedures:

  • Remain feasible in their implementation
  • Are measurable in their outcome performance
  • Can be adapted as required during study conduct

Changes to study processes result in adaptation of quality documents (e.g. SOP, WI, risk assessment).


The current validity of quality document must be clearly recognisable. Documents are:

  • Given a version number and date from which its procedures are valid
  • Uniquely numbered and signed
  • Active documents must be readily accessible to study staff
  • Archived documents are kept separate from active documents and are clearly marked as such
  • Both active and archived documents are only accessible to study staff in PDF format. This prevents accidental changes to documents

What do I need to do?

  • Perform applicable test-runs on risk control – and QA measures as they would be performed during study conduct, (e.g. emergency scenario by freezer failure, spillage of biological material, randomisation procedures)
  • Evaluate feasibility, potential disturbances, efficiency of implemented risk control measures (e.g. required resources such as time and staff)
  • Make necessary adjustments (e.g. SOPs, WIs, processes)
  • Train staff on validated QA procedures and risk control measures
  • Document training in training log


Staff trainings are done:

  • By qualified trainers or through self-training
  • On site, by telephone or web-based
  • Both at study initiation and during study conduct
  • Based on study delegated tasks
  • Prior to executing a task
  • Upon changes of study relevant documents (study protocol, IC, SOPs, etc)
  • Upon change of study relevant staff or individual responsibilities

All staff training must be documented. Trainer and trainee date and sign the training log. By signing, the trainee confirms to have read and understood its content.

On the training log always refer to type of documents having been trained (name, date, version number, etc.).

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

  • 5.0 Quality management
  • 5.2.2 Addendum: Sponsor oversight

ISO 9001:2015 – see in particular section

  • Quality Management Systems (access liable to costs)


  • CTU – Clinical Trials Unit
  • IC – Informed Consent
  • QA – Quality Assurance
  • SOP – Standard Operating Procedures
  • WI – Working Instructions
Set-Up ↦ Quality and Risk ↦ Documentation ↦ Process Validation and Training

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 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): Set-Up ↦ Quality and Risk ↦ Documentation ↦ Process Validation and Training

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