Basic↦Documents↦Standard Operating Procedures↦Purpose
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:
- Be educational with appropriate details, easy for study staff to understand
- Have a clear aim (e.g. safety reporting-, participant recruitment-, blood sampling-, IMP/IMD 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:
- 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
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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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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