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 (e.g. study protocol, lab-manual)
  • 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:


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:
  • 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


RA (e.g. Swissmedic) 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


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
  • CTU – Clinical Trials Unit
  • DMS – Document Management System
  • ICF – Informed Consent Form
  • IMD – Investigational Medical Device
  • 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

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): Basic ↦ Documents ↦ Standard Operating Procedures ↦ Purpose

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