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Submission of new test methods to EURL ECVAM

For the evaluation of a test method to enter the EURL ECVAM (pre)validation process, a new test method needs to be submitted to EURL ECVAM in the correct way.

The first step is to compile the electronic version of the test presubmission form.

After that, and if we ask you to do it, there is step two, which is a complete submission.

The entire EURL ECVAM test submission process follows two mandatory steps:

Step 1 - Presubmission

Presubmission is based on the EURL ECVAM test presubmission form and is a mandatory requirement for a test method to be considered for the EURL ECVAM validation process.

The completed test presubmission form (with all completed sections) will allow us to perform a preliminary assessment of the status of the development, optimisation and/or validation of the test method and its potential relevance with regard to the Three Rs (replacement, reduction, refinement of animal testing).

[collapsed]At this stage, we may share your submission with partners. These include our internal panels PARERE, ESAC, ESTAF, and (the external) ICATM. This is with the view of collecting alternative and external views at an early stage of the process of validation.

EURL ECVAM will inform the submitter on the outcome of the preliminary assessment of the test method based on the test presubmission form.

Only if the test method falls within the remit of EURL ECVAM's mission and fulfils the information requirements as outlined in the test presubmission form, EURL ECVAM will invite the submitter to proceed to Step 2.[/collapse]

Step 2 - Complete submission

This step requires the compilation of a detailed test submission template (TST), which we will provide. This lets you give us a comprehensive evaluation of the method that you have submitted.

We will provide you with extensive guidance. The test submitter will be formally invited to complete this step of the process.

Once we have evaluated it, we will provide you with a final decision. The decision will depend on whether the submitted test method qualifies for entering the (pre-)validation process and also a decision on what stage it will enter the EURL ECVAM validation process.

Here is some more guidance:

  • Complete submissions must be based on the EURL ECVAM Test Submission Template (TST) and must only be submitted after formal invitation by EURL ECVAM.
  • The structure of the TST follows the EURL ECVAM modular approach and allows for a comprehensive description of the test method's status with respect to its development, optimisation and/or validation.
  • The completed TST will enable EURL ECVAM to decide on the type of validation process most suitable for assessing and/or establishing the scientific validity of the proposed test method.
  • The types of validation processes include prospective validation, retrospective validation, and validation based on performance standards (these ones are often referred to 'catch-up' validations).
  • There is also the peer review process of ESAC.
  • The information submitted in the TST will also allow us to make decisions on the importance and therefore the prioritisation we need to make for the test method.
  • This will be done in close dialogue with the EURL ECVAM Advisory Structure and international partners.
  • EURL ECVAM will inform the submitter on the outcome of the comprehensive evaluation of the TST.
  • In the case where a test method qualifies for the process, this does not mean that we will automatically validate the method. There are many steps that we need to go through to validate a method. This takes time and you will need to work with us throughout this process.
  • We regularly prioritise all methods that have been submitted to us. This is particularly the case for methods that are likely to enter the validation process. The prioritisation process is based on pre-defined criteria and the available capacities that we have in the immediate future.
  • Unfortunately, we cannot guarantee that all submitted test methods can be validated by us. However, we will always do our best to help.

Note: a submitted test method will not be made available to external persons without the prior consent of the submitter.

How to submit a test method for validation

A list of the test methods assessed by EURL ECVAM and its international partners in the framework of ICATM is available through the Tracking System for Alternative methods towards Regulatory acceptance (TSAR).