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