Translational and applied research
Translational and applied research includes animals used for purposes as described in Article 5(b) and (c) excluding any regulatory use of animals.
This also includes discovery toxicology and investigations to prepare for the regulatory submission and method development. This does not include studies required for regulatory submissions.
The animals used for the creation of a new genetically altered animal line (including crossing of two lines) intended to be used for the purposes of translational or applied research (e.g. cancer research, vaccine development) should be recorded according to the purpose they are being created for. In addition, they should be reported in "Creation of a new genetic line – Animals used for the creation of a new genetically altered line/strain".
All animals carrying the genetic alteration should be reported during the creation of a new line. Also animals used in creation, such as for superovulation, vasectomy and embryo implantation, are reported here. The reporting should exclude non-genetically altered (wild type) offspring.
A new strain or line of genetically altered animals is considered to be "established" when transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed.
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