Answers to Knowledge Check in the postevent surveySME and academia Clinical Trials Information System CTIS twopart training webinar day 2Classified as public by the European Medicines Agency Europe ID: 889424
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1 An agency of the European Union Answers
An agency of the European Union Answers to Knowledge Check in the post - event survey SME and academia Clinical Trials Information System (CTIS) two - part training webinar â day 2 Classified as public by the European Medicines Agency © European Medicines Agency, 2021 Reproduction and/or distribution of the content of these training materials for non - commercial or commercial purposes is authorised, provided the European Medicines Agency is acknowledged as the source of the materials. The European Medicines Agency developed this training material to enhance public access to informa
2 tion on the Clinical Trial Information
tion on the Clinical Trial Information System (CTIS). This material describes a preliminary version of CTIS and may therefore not entirely describe the system as it is at the time of use of this material. The Agency does not warrant or accept any liability in relation to the use (in part or in whole) or the interpretation of the information contained in this training material by third parties. Classified as public by the European Medicines Agency Answers are shown in bold below. 1 . What does part I of an initial CTA include? ⢠Cover letter and proof of payment ⢠Information re
3 lated to the trial sites in each Member
lated to the trial sites in each Member State Concerned ⢠Trial - specific scientific information 2. When can Add MSC applications be created? ⢠Additional MSC CTAs can only be created if the CT has a status of authorised or authorised with conditions ⢠Additional MSC CTAs can be created if the CT has a status of not authorised ⢠Additional MSC CTAs can be created at any time, regardless of the status of a CT 2 Answers to questions from the post - event survey Classified as public by the European Medicines Agency Answers are shown in bold below. 3 . When should users submit a
4 substantial modification? ⢠When the
substantial modification? ⢠When the sponsor needs to make a change in the CT that is likely to have a substantial impact on its subjectsâ safety and rights or on the robustness and reliability of its data ⢠When the sponsor wants to extend the trial to another MSC ⢠When the sponsor wants to modify the trial to correct typographical errors or update contact details 4. What types of substantial modifications can be created? ⢠Single trial modifications ⢠Multi - trial modifications 3 Answers to questions from the post - event survey Classified as public by the European Medic
5 ines Agency Answers are shown in bold
ines Agency Answers are shown in bold below. 5 . Requests for Information can be viewed through: ⢠The RFIs tab ⢠The Notices and Alerts tab ⢠Clinical trials overview tab 6. What are the consequences of not answering a Clinical Trial Application (CTA) RFI? ⢠The CTA process will continue ⢠The initial CTA will lapse ⢠The CTA validation phase will be extended 7. The fields published on the CTIS public website, even in the case of deferral, include: ⢠EU Clinical Trial Number ⢠Sponsor name and address ⢠Identification of the investigational medicinal products (IMPs) 4