Common use of Assessment Phase Clause in Contracts

Assessment Phase. After successful validation, the SM is assessed by the FAMHP and in principle 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 EC with the exception of the modifications related to the quality part of the dossier which are only assessed by the FAMHP. The aspects covered by Part II are assessed by the EC. It is to be noted that the EC will have access to the submission dossier for substantial modification on Part I (excepted quality documentation) even if “A.3 Notification for an opinion to the Ethics Committee” was not ticket in the EU application form. The EC will decide on case by case basis if an EC evaluation (and thus an EC approval) is needed. 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 requests for additional information from the national contact point. SM contents covered by the 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. If the substantial modification is related to an update of the Inform Consent Form (ICF), the ICF is reviewed by the EC in only one language. The correct translation into all other languages remains the responsibility of the sponsor. Comments/remarks on the ICF could be provided by the EC into one of the language versions of the PDF document. In this case, the commented PDF will be added as an annex to the RFI letter and these comments/remarks have to be taken into account by the sponsor when providing the answers to the questions. However, the sponsor remains responsible for the translation of the updated ICF into the other ICF’s languages. In the case of a RFI letter, the sponsor is called upon to remedy the deficiencies noted or to supply the requested information within 12 days at the most 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 (Eudralink/CESP if possible) to the national contact point (XXXxxxxx@xxxxx-xxxx.xx). In case a question of the deficiency letter should be unclear it is recommended to contact the national contact point by E-mail. As only one round of questions is foreseen in the CTR, it is recommended to formulate answers in a clear unambiguous way and check their completeness before sending them to the national contact point.

Assessment Phase. After successful validation, the SM CTA is assessed by the FAMHP and in principle 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 EC with the exception of the modifications related to the quality part of the dossier which are only assessed Ethics Committee selected by the FAMHPCollege. The aspects covered by Part II are assessed by the EC. It is to be noted that the EC will have access to the submission dossier for substantial modification on Part I (excepted quality documentation) even if “A.3 Notification for an opinion to the Ethics Committee” was not ticket in the EU application form. The EC will decide on case by case basis if an EC evaluation (and thus an EC approval) is needed. 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 requests for additional information from the national contact point. SM contents Contents covered by the 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. If the substantial modification is related to an update of the Inform Informed Consent Form Forms (ICF), the ICF is ICFs) are reviewed by the EC in only one language. The correct translation into all other languages remains the responsibility of the sponsor. Comments/remarks on the ICF could be provided by the EC into one of the language versions of the PDF document. In this case, the commented PDF will be added as an annex to the RFI letter and these comments/remarks have to be taken into account by the sponsor when providing the answers to the questions. However, the sponsor remains responsible for the translation of the updated ICF into the other ICF’s languages. In the case of a RFI deficiency letter, the sponsor is called upon to remedy the deficiencies noted or to supply the requested information within 12 days at the most 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 (Eudralink/CESP if possible) to the national contact point (XXXxxxxx@xxxxx-xxxx.xx). In case a question of the deficiency letter should be unclear it is recommended to contact the national contact point by E-mail. As only one round of questions is foreseen in the CTR, it is recommended to formulate answers in a clear unambiguous way and check their completeness before sending them to the national contact point.

Assessment Phase. After successful validation, the SM CTA is assessed by the FAMHP and in principle 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 EC with the exception of the modifications related to the quality part of the dossier which are only assessed Ethics committee selected by the FAMHP. The College while the aspects covered by Part II are assessed by the EC. It is to be noted that the EC will have access to the submission dossier for substantial modification on Part I (excepted quality documentation) even if “A.3 Notification for an opinion to the Ethics Committee” was not ticket in the EU application form. The EC will decide on case by case basis if an EC evaluation (and thus an EC approval) is neededcommittee. During the assessment procedure of Part 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 requests for additional information deficits from the national contact point. SM contents Contents covered by the Part II of the CTA pursuant to the CTR are assessed in parallel by the Ethics Committeecommittee. 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 part I of the SM dossier. If the substantial modification is related to an update of the Inform Informed Consent Form Forms (ICF), the ICF is ICFs) are reviewed by the EC in only one language. The correct translation into all other languages remains the responsibility of the sponsor. Comments/remarks on the ICF could be provided by the EC into one of the language versions of the PDF document. In this case, the commented PDF will be added as an annex to the RFI deficiency letter and these comments/remarks have to be taken into account by the sponsor when providing the answers to the questions. However, the sponsor remains responsible for the translation of the updated ICF into the other ICF’s languages. In the case of a RFI deficiency letter, the sponsor is called upon to remedy the deficiencies noted or to supply the requested information within 12 days at the most 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 (Eudralink/CESP Eudralink if possible) to the national contact point (XXXxxxxx@xxxxx-xxxx.xx). In case a question of the deficiency letter should be unclear it is recommended to contact the national contact point by E-mail. As only one round of questions is foreseen in the CTR, it is recommended to formulate answers in a clear unambiguous way and check their completeness before sending them to the national contact point.

Assessment Phase. After successful validation, the SM is assessed by the FAMHP and in principle the Ethics Committee 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 EC with Ethics committee while the exception of the modifications related to the quality part of the dossier which are only assessed by the FAMHP. The aspects covered by Part II are assessed by the EC. It is to be noted that the EC will have access to the submission dossier for substantial modification on Part I (excepted quality documentation) even if “A.3 Notification for an opinion to the Ethics Committee” was not ticket in the EU application form. The EC will decide on case by case basis if an EC evaluation (and thus an EC approval) is neededcommittee. During the assessment procedure of Part 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 requests for additional information deficits from the national contact point. SM contents covered by the Part II of the CTA pursuant to the CTR are assessed in parallel by the Ethics Committeecommittee. 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 part I of the SM dossier. If the substantial modification is related to an update of the Inform Consent Form (ICF), the ICF is reviewed by the EC in only one language. The correct translation into all other languages remains the responsibility of the sponsor. Comments/remarks on the ICF could be provided by the EC into one of the language versions of the PDF document. In this case, the commented PDF will be added as an annex to the RFI deficiency letter and these comments/remarks have to be taken into account by the sponsor when providing the answers to the questions. However, the sponsor remains responsible for the translation of the updated ICF into the other ICF’s languages. In the case of a RFI deficiency letter, the sponsor is called upon to remedy the deficiencies noted or to supply the requested information within 12 days at the most 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 (Eudralink/CESP if possible) to the national contact point (XXXxxxxx@xxxxx-xxxx.xx). In case a question of the deficiency letter should be unclear it is recommended to contact the national contact point by E-mail. As only one round of questions is foreseen in the CTR, it is recommended to formulate answers in a clear unambiguous way and check their completeness before sending them to the national contact point.