3.5.2 Protocols for methods and assays - Revision history

Rene.Bernard: /* C. Resources */

2025-06-10T08:37:56Z

C. Resources

← Older revision		Revision as of 08:37, 10 June 2025
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	* [https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=cxNQxR 3.5.2 Protocol for experimental method.docx]		* [https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=cxNQxR 3.5.2 Protocol for experimental method.docx]

			'''ADD PRO-MAP'''

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Bjoerngerlach at 12:25, 15 June 2023

2023-06-15T12:25:30Z

← Older revision		Revision as of 12:25, 15 June 2023
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	back to [[Toolbox]]		back to [[Toolbox]]

	Next item: [[4.1.~~1 Risk assessment~~]]		Next item: [[3.5.3 Minimum reporting guidelines]]

ChristophEmmerich at 13:14, 29 April 2021

2021-04-29T13:14:02Z

← Older revision		Revision as of 13:14, 29 April 2021
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	This item is related to one of the Core Requirements (Core Requirement 12 - "Protocols for experimental methods must be available") and is, therefore, considered as essential.		This item is related to one of the Core Requirements (Core Requirement 12 - "Protocols for experimental methods must be available") and is, therefore, considered as essential.

	Protocol for experimental methods – A written description of materials and experimental method(s) that includes sufficient details that would enable the reliable and consistent use of the method(s) by different people and at different times. Such protocols should be dated and include author(s) to make sure that the completed and reported studies can be readily traced to the correct protocols. EQIPD has no expectations regarding the format of such protocols and does not expect protocols to follow any formal development, review or validation procedure (as in GLP).		Protocol for experimental methods – A written description of materials and experimental method(s) that includes sufficient details that would enable the reliable and consistent use of the method(s) by different people and at different times.

			== B. Guidance & Expectations ==
			Protocols for experimental methods should be dated and should include author(s) to make sure that the completed and reported studies can be readily traced to the correct protocols. EQIPD has no expectations regarding the format of such protocols and does not expect protocols to follow any formal development, review or validation procedure (as in GLP).

	~~== B~~. ~~Guidance & Expectations ==~~		Importantly, Protocols for experimental methods
	~~General~~ information to be included in ~~Experimental Method~~ Protocols may involve:		* must be available at all times,
			* must be referenced or duplicated in the experimental record
			* must contain all relevant information about materials and reagents (e.g. it is advisable to use RRIDs), equipment and procedures to enable the reliable and consistent use of the method,
			* must not be overwritten or deleted when amended or when a new version was created and referenced,

			Further information to be included in Protocols for experimental methods may involve:
	* Training/competence of personnel required to perform the method (see also Toolbox item [[3.2.4 Training on specific methods, tasks and activities\| 3.2.4]])		* Training/competence of personnel required to perform the method (see also Toolbox item [[3.2.4 Training on specific methods, tasks and activities\| 3.2.4]])
	* Definition of potential safety issues derived from the study (e.g., biosafety, chemicals, radioactivity…)		* Definition of potential safety issues derived from the study (e.g., biosafety, chemicals, radioactivity…)
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	For animal research:		For animal research:
	* ~~Confirmation~~ that there are no alternative methods		* Justification that there are no alternative methods
	* Definition of humane endpoints		* Definition of humane endpoints
	* Further items from [[ARRIVE 2.0]] recommended set		* Further items from the [[ARRIVE 2.0]] recommended set

	The completed protocols can be saved in the Dossier at 3.5.2.		The completed protocols can be saved in the Dossier at 3.5.2.

IAL: English language edits

2020-09-30T11:51:47Z

English language edits

← Older revision		Revision as of 11:51, 30 September 2020
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	This item is related to one of the Core Requirements (Core Requirement 12 - "Protocols for experimental methods must be available") and is, therefore, considered as essential.		This item is related to one of the Core Requirements (Core Requirement 12 - "Protocols for experimental methods must be available") and is, therefore, considered as essential.

	Protocol for experimental methods – A written description of materials and experimental method(s) that includes sufficient details that would enable the reliable and consistent use of the method(s) by different people and different times. Such protocols should ~~have~~ be dated and include author(s) to make sure that the completed and reported studies can be readily traced to the correct protocols. EQIPD has no expectations regarding the format of such protocols and does not expect protocols to follow any formal development, review or validation procedure (as in GLP).		Protocol for experimental methods – A written description of materials and experimental method(s) that includes sufficient details that would enable the reliable and consistent use of the method(s) by different people and at different times. Such protocols should be dated and include author(s) to make sure that the completed and reported studies can be readily traced to the correct protocols. EQIPD has no expectations regarding the format of such protocols and does not expect protocols to follow any formal development, review or validation procedure (as in GLP).


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	General information to be included in Experimental Method Protocols may involve:		General information to be included in Experimental Method Protocols may involve:
	* Training/competence of personnel required to perform the method (see also Toolbox item [[3.2.4 Training on specific methods, tasks and activities\| 3.2.4]])		* Training/competence of personnel required to perform the method (see also Toolbox item [[3.2.4 Training on specific methods, tasks and activities\| 3.2.4]])
	* Definition of potential safety issues derived from the study (e.g. biosafety, chemicals, ~~radioactive…~~)		* Definition of potential safety issues derived from the study (e.g., biosafety, chemicals, radioactivity…)
	* Protocols of experimental methods should clearly state whether calibration is needed and, if yes, the procedure should be described (when/how often). If no calibration is required, it should be explicitly stated in the protocol (see also Core Requirement 14 - "Research equipment and tools must be suitable for intended use and ensure data integrity" and Toolbox item [[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use\| 3.3.2]])		* Protocols of experimental methods should clearly state whether calibration is needed and, if yes, the procedure should be described (when/how often). If no calibration is required, it should be explicitly stated in the protocol (see also Core Requirement 14 - "Research equipment and tools must be suitable for intended use and ensure data integrity" and Toolbox item [[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use\| 3.3.2]])

Bjoerngerlach at 18:45, 5 September 2020

2020-09-05T18:45:54Z

← Older revision		Revision as of 18:45, 5 September 2020
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	* Further items from [[ARRIVE 2.0]] recommended set		* Further items from [[ARRIVE 2.0]] recommended set

	The completed protocols can be saved in the Dossier at [[3.5.2 ~~Protocols for methods and assays\| 3.5.2]]~~.		The completed protocols can be saved in the Dossier at 3.5.2.

Bjoerngerlach at 18:45, 5 September 2020

2020-09-05T18:45:08Z

← Older revision		Revision as of 18:45, 5 September 2020
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	* Further items from [[ARRIVE 2.0]] recommended set		* Further items from [[ARRIVE 2.0]] recommended set

	The completed protocols can be saved in the Dossier at [[3.5.2 Protocols for methods and assays\|3.5.2]].		The completed protocols can be saved in the Dossier at [[3.5.2 Protocols for methods and assays\| 3.5.2]].

Bjoerngerlach at 18:44, 5 September 2020

2020-09-05T18:44:41Z

← Older revision		Revision as of 18:44, 5 September 2020
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	* Further items from [[ARRIVE 2.0]] recommended set		* Further items from [[ARRIVE 2.0]] recommended set

	The completed protocols can be saved in the Dossier at [[3.5.2 Protocols for methods and assays\|3.5.2.]]		The completed protocols can be saved in the Dossier at [[3.5.2 Protocols for methods and assays\|3.5.2]].

Bjoerngerlach at 18:43, 5 September 2020

2020-09-05T18:43:48Z

← Older revision		Revision as of 18:43, 5 September 2020
Line 16:		Line 16:
	* Further items from [[ARRIVE 2.0]] recommended set		* Further items from [[ARRIVE 2.0]] recommended set

	The completed protocols can be saved in the Dossier at [[3.5.2 Protocols for methods and assays\| 3.5.2.]]		The completed protocols can be saved in the Dossier at [[3.5.2 Protocols for methods and assays\|3.5.2.]]

Bjoerngerlach at 18:42, 5 September 2020

2020-09-05T18:42:47Z

Bjoerngerlach at 10:41, 3 September 2020

2020-09-03T10:41:33Z

← Older revision		Revision as of 10:41, 3 September 2020
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	The completed protocols can be saved in the Dossier at 3.5.2.		The completed protocols can be saved in the Dossier at 3.5.2.


	'''RISK ASSESSMENT'''		'''RISK ASSESSMENT'''

← Older revision		Revision as of 18:42, 5 September 2020
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	== B. Guidance & Expectations ==		== B. Guidance & Expectations ==
	General information to be included in Experimental Method Protocols may involve:		General information to be included in Experimental Method Protocols may involve:
	* Training/competence of personnel required to perform the method (see also Toolbox item 3.2.4)		* Training/competence of personnel required to perform the method (see also Toolbox item [[3.2.4 Training on specific methods, tasks and activities\| 3.2.4]])
	* Definition of potential safety issues derived from the study (e.g. biosafety, chemicals, radioactive…)		* Definition of potential safety issues derived from the study (e.g. biosafety, chemicals, radioactive…)
	* Protocols of experimental methods should clearly state whether calibration is needed and, if yes, the procedure should be described (when/how often). If no calibration is required, it should be explicitly stated in the protocol (see also Core Requirement 14 - "Research equipment and tools must be suitable for intended use and ensure data integrity" and Toolbox item 3.3.2)		* Protocols of experimental methods should clearly state whether calibration is needed and, if yes, the procedure should be described (when/how often). If no calibration is required, it should be explicitly stated in the protocol (see also Core Requirement 14 - "Research equipment and tools must be suitable for intended use and ensure data integrity" and Toolbox item [[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use\| 3.3.2]])

	For animal research:		For animal research:
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	* Further items from [[ARRIVE 2.0]] recommended set		* Further items from [[ARRIVE 2.0]] recommended set

	The completed protocols can be saved in the Dossier at 3.5.2.		The completed protocols can be saved in the Dossier at [[3.5.2 Protocols for methods and assays\| 3.5.2.]]


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	== C. Resources ==		== C. Resources ==
	Templates for experimental methods descriptions (protocols):		Templates for experimental methods descriptions (protocols):
	* 3.5.2 Protocol for experimental method.docx		* [https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=cxNQxR 3.5.2 Protocol for experimental method.docx]