2.2.1 Use of SOPs for standard experiments - Revision history

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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	== A. Background & Definitions ==		== A. Background & Definitions ==
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	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.

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 == 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: /* 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: 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..."