How to write a Standard Operating Procedure (SOP)

Description
Quality

Standard Operating Procedures (SOPs) are written instructions that describe how to complete research-related activities to ensure consistent and correct execution. In other words, it is a document consisting of information on who does what, where, when, why, and how and is considered as ‘standard practice’. In addition, they make trial staff communications and training easier by encouraging self-proficiency.

In order for sites, sponsors and CROs to demonstrate their commitment to subject safety and quality of data when conducting clinical trials, SOPs are a must-have.

Many however see SOP writing as quite a daunting task. This two hours TRIUM Training will convince you otherwise by giving clear, concise guidance on what to include (and what not), how to begin and the necessary features to include. Suggestions for training, implementation and maintenance are also provided to ensure everyone gets the full picture. Participants will be encouraged to share their thoughts and to learn from one another in this interactive session.

At the end, you will receive a certificate for attendance and handy hand-outs for use in the field.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Define an SOP
  • Describe the purpose and advantages of an SOP
  • Start writing and implementing SOPs for your clinical research organization to ensure compliance and safeguard subject safety and data quality
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”