Outline of the EURL ECVAM test method submission process
The EURL ECVAM test submission process follows two mandatory steps described below.
STEP 1: PRESUBMISSION
Presubmissions must be based on the EURL ECVAM Test Presubmission Form (TPF), and are a mandatory requirement for a test method to be eventually considered for the EURL ECVAM validation process.
- The completed TPF will allow EURL ECVAM to perform a preliminary assessment of the status of development, optimisation and/or validation of the test method.
- Already during this preliminary assessment phase (Step 1), EURL ECVAM may share the TPF with its Advisory Structure and international partners, e.g. the EURL ECVAM's Network for Preliminary Assessment of Regulatory Relevance (PARERE), the EURL ECVAM Scientific Advisory Committee (ESAC) and, to the extent possible, with the EURL ECVAM Stakeholder Forum (ESTAF) and the members of the International Cooperation on Alternative Test Methods (ICATM), in view of a) collecting input on the possible prioritisation of the test method and b) possible scientific issues.
- EURL ECVAM will inform the submitter on the outcome of the preliminary assessment of the test method based on the TPF. Only if the test method falls within the remit of EURL ECVAM's mission and fulfils the information requirements as outlined in the TPF, EURL ECVAM will invite the submitter to proceed to Step 2 (complete submission) and will forward the Test Submission Template (TST).
STEP 2: COMPLETE SUBMISSION
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 it 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
- validation based on Performance Standards i.e. validation of new or updated test methods found sufficiently similar to the validated reference method (often colloquially referred to as “catch-up” validation).
- peer review by the ESAC
- The information submitted in the TST will also allow making decisions on the prioritisation of 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.