3.5.2 Protocols for methods and assays

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​​​A. Background & Definitions

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).​


B. Guidance & Expectations

General information to be included in Experimental Method Protocols may in​volve:

  • Training/competence of personnel required to perform the method (see also Toolbox item 3.2.4)
  • 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​)

For animal research:

  • Confirmation that there are no alternative methods
  • Definition of humane endpoints
  • Further items from ARRIVE 2.0 recommended set

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


RISK ASSESSMENT

  • Is there a process in place to make sure that the most recent protocol is being used or followed?


PLEASE DO NOT FORGET

  • ​To support versioning of the protocols (including dates and authors) to make sure that the completed and reported studies can be readily traced to the correct protocols


C. Resources

Templates for experimental methods descriptions (protocols):



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Next item: 4.1.1 Risk assessment​​