Insert EU Currency Field to the Clinical Trial Agreement and eSign it in minutes

Aug 6th, 2022
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How to Insert EU Currency Field to the Clinical Trial Agreement

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this video outlines in short how to fill out one of the three subsections of the part 1 section of an initial clinical trial application the trial details subsection in the sponsor workspace in part 1 use the lock button of the trial details subsection to be able to work on the various subsections and click on the arrows to expand the working areas of each subsection any field with an asterisk is a mandatory field the video will focus on those fields only more information on the content and the structure of the part 1 can be found in the e-learning of this module in the trial identifiers subsection you can edit the full trial title and you need to insert a public title you can add a translation of the titles using the respective buttons on the right side select the language from the drop-down list type the translated title and click on the confirm button below you can add the protocol code and secondary identifiers for the trial if they are available scroll down and open the trial info

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2.1 EU countries Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
A Clinical trial application (CTA) is a request made by the sponsors to the Member States Concerned (MSCs) for the authorisation to perform an action related to CTs conducted in the EU.
Definition: The formal process through which a company or other body requests permission from the US Food and Drug Administration (FDA) to make and sell a drug in the USA. In Europe, the equivalent process is known as a marketing authorization application (MAA).
CTIS is a single entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data which includes a public searchable database for healthcare professionals, patients and the general public.
On 31 January 2022, the Clinical Trials Regulation (CTR) will come into application harmonising the submission, assessment and supervision processes for clinical trials in the European Union (EU). The backbone of the changes brought about by the CTR is the new Clinical Trials Information System (CTIS).
EU-CTD obliges multiple safety submissions to NCAs and ECs, whereas EU-CTR requires all safety reporting via EudraVigilance. A single safety report can be submitted for trials involving more than one IMP, but all unexpected events which affect a trials benefit-risk balance must be reported within 15 days.
Submissions made to EudraCT are subject to regulatory requirements under the erstwhile EU Clinical Trials Directive. This has now been replaced with the EU Clinical Trials Regulation (CTR), which requires that all initial CTAs should be submitted via CTIS.
The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission. CTIS went live with a searchable public website on 31 January 2022.

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