Common use of Assessment Phase Clause in Contracts

Assessment Phase. After successful validation, the SM is assessed by the FAMHP and the Ethics committee that was responsible for the assessment of the initial dossier. The assessment regarding the aspects covered by Part I of the CTA is performed in parallel by the FAMHP and the Ethics committee while the aspects covered by Part II are assessed by the Ethics committee. During the assessment procedure of part I of the dossier, if the SM dossier is not directly granted a positive assessment, the sponsor will receive a list of questions and/or deficits from the national contact point. SM contents covered by the future Part II of the CTA pursuant to the CTR are assessed in parallel by the Ethics committee. Questions and/or requests for additional information regarding these aspects are sent to the sponsor by the national contact point at the same time with the list of questions related to part I of the SM dossier. In the case of deficiency letter(s), the sponsor is called upon to remedy the deficiencies noted or to supply the requested information within 12 days at the most (see table in annex I) in order to comply with the deadlines specified in the CTR. As before, the answer here should also be as a single response sent by E-mail to the national contact point (▇▇▇▇▇▇▇▇@▇▇▇▇▇-▇▇▇▇.▇▇). In case a question of the deficiency letter should be unclear it is recommended to contact the national contact point by E-mail.

Assessment Phase. After successful validation, the SM CTA is assessed by the FAMHP and the Ethics committee that was responsible for the assessment of the initial dossiercommittee. The assessment regarding the aspects covered by Part I of the CTA is performed in parallel by the FAMHP and the Ethics committee selected by the future College while the aspects covered by Part II are assessed by the Ethics committee. During the assessment procedure of part I of the dossier, if the SM CTA dossier is not directly granted a positive assessment, the sponsor will receive a list of questions and/or deficits from the national contact point. SM contents Contents covered by the future Part II of the CTA pursuant to the CTR are assessed in parallel by the Ethics committee. Questions and/or requests for additional information regarding these aspects are sent to the sponsor by the national contact point at the same time with the list of questions related to part I of the SM dossier. In the case of deficiency letter(s), the sponsor is called upon to remedy the deficiencies noted or to supply the requested information within 12 days at the most (see table in annex I) in order to comply with the deadlines specified in the CTR. As before, the answer here should also be as a single response sent by E-mail to the national contact point (▇▇▇▇▇▇▇▇@▇▇▇▇▇-▇▇▇▇.▇▇). In case a question of the deficiency letter should be unclear it is recommended to contact the national contact point by E-mail.