What is it? Why is it important?

Process verifications are documented activities that verify the feasibility of planned study processes, with the aim that performance does not deviate and is executed in a consistent and homogeneous manner.

In order for these verified processes to be correctly implemented requires for study staff to be trained accordingly.

 

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. SOPs, WIs, defined processes, essential documents).

More

The current status and validity of quality documents must be:

  • Clearly identifiable (e.g. version number, date from when the document is valid, contain applicable signatures)
  • Readily accessible to study staff
  • Protected from accidental alterations and changes by only being available to study staff in PDF format (e.g. applicable to both active and archived documents)

 

Archived quality documents:

  • Are clearly marked as such and are kept separate from active documents. This will prevent the accidental retrieval of archived documents

What do I need to do?

As a SP-INV

  • Perform applicable test-runs on the established processes and risk control-measures including Quality Assurance (QA) measures, as planned during study conduct, (e.g. emergency plan by freezer failure, spillage of biological material, randomisation procedures)
  • Evaluate feasibility, potential disturbances, efficiency of implemented measures (e.g. required resources)
  • Make necessary adjustments (e.g. SOPs, WIs, processes)
  • Train staff on validated processes and risk control- and QA measures
  • Document training in training log

 

Staff trainings are documented with trainings performed:

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

More

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

References

ICH GCP E6(R2) – see in particular guidelines

  • 5.0 Quality management
  • 5.2.2 Addendum: Sponsor oversight

ISO 9001:2015 (access liable to costs) – see in particular section

  • Quality Management Systems

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IC – Informed Consent
  • ISO – International Organization for Standardization
  • QA – Quality Assurance
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Development ↦ Quality and Risk ↦ Study Risk Management ↦ Process Verification and Training
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Quality and Risk ↦ Study Risk Management ↦ Process Verification and Training

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