What is it? Why is it important?

In order to ensure that study tasks are routinely carried-out and performed in a standardised manner, requires that directives are documented in Standard Operating Procedures (SOP).

SOPs are step-by-step workflows providing instructions with the aim to:

  • Achieve uniformity of performance
  • Define individual responsibilities
  • Prevent deviations from defined procedures
  • Ensure ongoing pre-fixed quality output(s)
  • Increase work efficiency
  • Reduce miscommunication

SOPs are:

  • Superordinate documents that make references to supporting documents (e.g. WIs, checklists, logs)
  • Internally and study site controlled documents to be imbedded in the DMS of the study

SOPs should:

  • Be educational with appropriate details, easy for study staff to understand
  • Have a clear aim (e.g. safety reporting-, participant recruitment-, blood sampling-, IMP storage-, data entry-, archiving procedures)
  • Adhere to a standardised format (e.g. SOP template)

More

It is advisable to write an SOP-for-SOP, which describes how to manage SOPs in a study. Aspects to include are:

  • Processes on how to write, review and release SOPs. Make a list of all study SOPs including a timeline for the review of its processes
  • Whom to train on which SOPs. Consider setting-up an SOP matrix that describes what staff member should be trained which SOPs
  • Timelines for study staff to be trained on reviewed and newly released SOPs

What do I need to do?

As a SP-INV you are responsible to provide:

  • Written SOPs that ensure that:
    • Participant safety and rights are protected
    • Data quality and integrity is guaranteed
  • Site-INV(s) with study relevant SOPs. Still, during study conduct the Site-INV might use site specific SOPs that describe site-specific processes

In order to guarantee SOP compliance:

  • Provide for study mandatory SOPs
  • Ensure staff is properly SOP trained. Provide refresher trainings at regular intervals
  • Check SOP compliance during study monitoring
  • Allow for ongoing feedback regarding SOP inconsistencies or errors
  • Regularly revise SOPs to assess the ongoing validity and effectiveness of its processes

Document SOP training by documenting:

  • The SOP training date
  • Trainer(s) and staff trained (e.g. name, function)
  • Type of SOP trained, include SOP version

More

RA use SOPs as compliance criteria during an inspection (e.g. Swissmedic inspection). In this regard the documentation of SOP trainings of study staff is crucial, as it ensures compliance with study required processes.

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

  • 1.55 Standard Operating Procedures (SOPs)
  • 5.1.1 Sponsor’s Responsibilities for Quality Assurance
  • 5.5.3.b) SOP Coverage
Abbreviations
  • CTU – Clinical Trials Unit
  • DMS – Document Management System
  • ICF – Informed Consent Form
  • IMP – Investigational Medicinal Product
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SOP - Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • WI – Working Instruction
Basic ↦ Documents ↦ Standard Operating Procedures ↦ Purpose
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): Basic ↦ Documents ↦ Standard Operating Procedures ↦ Purpose

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