2.2.1 Use of SOPs for standard experiments

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​​​​​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

Note Not every process requires a detailed SOP. Prioritise SOPs for recurring, critical, or complex procedures where standardisation improves consistency and traceability (e.g., frequently used experimental protocols). Nevertheless, research units may develop SOPs for any procedures for which they perceive a need for additional guidance, standardisation, or documentation.


​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 protocol should describe extensively instructions needed to perform the study, including routine activities.

C. Resources

  • Hollmann et al. (2020) Ten simple rules on how to write a standard operating procedure [1]
  • McElroy J (2018) ​Writing Bulletproof SOPs: Best Practices For Life Sciences Companies. [2]
  • Template and instructions of standard operating procedure: HANDBOOK: QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH, Appendix 3 [3]

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