2.2.1 Use of SOPs for standard experiments - Revision history

Bjoerngerlach: /* B. Guidance & Expectations */

2026-07-03T12:27:40Z

‎B. Guidance & Expectations

Bjoerngerlach at 12:27, 3 July 2026

2026-07-03T12:27:21Z

Bjoerngerlach: /* C. Resources */

2021-10-25T17:27:55Z

‎C. Resources

Bjoerngerlach: /* C. Resources */

2021-10-25T17:27:09Z

‎C. Resources

ChristophEmmerich at 12:46, 24 March 2021

2021-03-24T12:46:53Z

Bjoerngerlach at 17:17, 5 September 2020

2020-09-05T17:17:33Z

Bjoerngerlach: Created page with "== A. Background & Definitions == Standard operating procedures (SOPs) is a set of written instructions that define a standardized way to perform routine activ..."

2020-09-02T15:30:42Z

Created page with "== A. Background & Definitions == Standard operating procedures (SOPs) is a set of written instructions that define a standardized way to perform routine activ..."

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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

'''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. [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]

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

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 * Deviations to SOP should be described and reported as well as their impact on the data and conclusions of the study
-Note
+'''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.
@@ Line 18: / Line 18: @@
 * 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 ==

← Older revision		Revision as of 12:27, 3 July 2026
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	* Quality professionals should have access to SOPs to verify that procedures are performed as intended		* 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		* 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.

← Older revision		Revision as of 17:17, 5 September 2020
Line 1:		Line 1:
	== A. Background & Definitions ==		== 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.		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.

@@ Line 18: / Line 18: @@
 == C. Resources ==
-* Hollmann et al. (2020) Ten simple rules on how to write a standard operating procedure [https://journals.plos.org/ploscompbiol/article?id=10.1371/journal.pcbi.1008095]
+* 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]
 * 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]

@@ Line 14: / Line 14: @@
 '''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.
+* If no SOPs are available, the study protocol should describe extensively instructions needed to perform the study, including routine activities.

2.2.1 Use of SOPs for standard experiments - Revision history

Bjoerngerlach: /* ​B. Guidance & Expectations */

Bjoerngerlach at 12:27, 3 July 2026

Bjoerngerlach: /* C. Resources */

Bjoerngerlach: /* C. Resources */

ChristophEmmerich at 12:46, 24 March 2021

Bjoerngerlach at 17:17, 5 September 2020

Bjoerngerlach: Created page with "== ​​​​​A. Background & Definitions == Standard operating procedures (SOPs) is a set of written instructions that define a standardized way to perform routine activ..."

Bjoerngerlach: /* B. Guidance & Expectations */

Bjoerngerlach: Created page with "== A. Background & Definitions == Standard operating procedures (SOPs) is a set of written instructions that define a standardized way to perform routine activ..."