2.2.1 Use of SOPs for standard experiments

​​​​​A. Background & Definitions

Standard operating procedures (SOPs) is a set of written instructions that define a standardized way to perform routine activities. SOPs contribute to maintain the quality and integrity of generated data.

​B. Guidance & Expectations

• SOPs must be clear and concise, so that all persons involved in the study understand how to perform their activities
• SOPs should be dated, signed/approved by an authorized scientist and saved in a secure place (e.g. non-modifiable by non-authorized persons). When amending an SOP, previous version of the SOP must be retained
• SOPs should be distributed to everyone involved in the study
• Everyone involved in the study should confirm reading of the SOP. Proof of understanding by everyone involved in a study (e.g. validation of training on achievement of routine activities described in the SOPs) should be documented before the realization of the study
• Quality professionals should have access to SOPs to verify that procedures are performed as intended
• Deviations to SOP should be described and reported as well as their impact on the data and conclusions of the study

​PLEASE DO NOT FORGET

• SOPs must be clear and adapted to the activities, poorly written SOPs are a source of errors. Regular review of the SOPs improves their quality.
• If no SOPs are available, the study plan should describe extensively instructions needed to perform the study, including routine activities.

C. Resources

• McElroy J (2018) ​Writing Bulletproof SOPs: Best Practices For Life Sciences Companies. [1]
• Template and instructions of standard operating procedure: HANDBOOK: QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH, Appendix 3 [2]

​​

---

back to Toolbox

Next item: 2.2.2 Use of template for (manual) data recording​