Difference between revisions of "2.2.1 Use of SOPs for standard experiments"
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'''PLEASE DO NOT FORGET''' | '''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. | * 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 | + | * If no SOPs are available, the study protocol should describe extensively instructions needed to perform the study, including routine activities. |
== C. Resources == | == C. Resources == | ||
| + | * Hollmann et al. (2020) Ten simple rules on how to write a standard operating procedure [https://doi.org/10.1371/journal.pcbi.1008095] | ||
* McElroy J (2018) Writing Bulletproof SOPs: Best Practices For Life Sciences Companies. [https://www.outsourcedpharma.com/doc/writing-bulletproof-sops-best-practices-for-life-sciences-companies-0001?vm_tId=2074360&user=4a4511ca-f38f-497a-bf6f-42310c5093dd&utm_source=et_6214173&utm_medium=email&utm_campaign=OUTPH_07-18-2018&utm_term=4a4511ca-f38f-497a-bf6f-42310c5093dd&utm_content=Writing+Bulletproof+SOPs%253a+Best+Practices+For+Life+Sciences+Companies] | * McElroy J (2018) Writing Bulletproof SOPs: Best Practices For Life Sciences Companies. [https://www.outsourcedpharma.com/doc/writing-bulletproof-sops-best-practices-for-life-sciences-companies-0001?vm_tId=2074360&user=4a4511ca-f38f-497a-bf6f-42310c5093dd&utm_source=et_6214173&utm_medium=email&utm_campaign=OUTPH_07-18-2018&utm_term=4a4511ca-f38f-497a-bf6f-42310c5093dd&utm_content=Writing+Bulletproof+SOPs%253a+Best+Practices+For+Life+Sciences+Companies] | ||
* Template and instructions of standard operating procedure: HANDBOOK: QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH, Appendix 3 [https://www.who.int/tdr/publications/documents/quality_practices.pdf?ua=1] | * Template and instructions of standard operating procedure: HANDBOOK: QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH, Appendix 3 [https://www.who.int/tdr/publications/documents/quality_practices.pdf?ua=1] | ||
Latest revision as of 17:27, 25 October 2021
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 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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