Common use of Validation Phase Clause in Contracts

Validation Phase. The validation of the substantial modification is performed by the national contact point. Timelines of the CTR apply for the validation phase, while timelines of the law of 7 May 2004 (28 days or 15 days) apply once the T0 is given for the start of the procedure. However as far as possible, timelines for validation will be kept short. At the end of the validation phase which will last a maximum of 6 days (except for phase I mono- national trials for which the validation phase will last a maximum of 5 days), the sponsor will receive a notice of validation (beginning of assessment) from the national contact point. An operational calendar with a clear overview of the different timelines will be part of this notification to the sponsor. If the validation shows that deficiencies are present or that relevant documentation is missing, leading to the SM itself not being valid, the sponsor is granted a 10-day period to remove the deficiencies. The corresponding response by the sponsor is to be sent to the national contact point (▇▇▇▇▇▇▇▇@▇▇▇▇▇-▇▇▇▇.▇▇). The national contact point evaluates the supplemented documentation within 5 days after receipt of the comments or the amended SM dossier.