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Upload initials trial

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 information subsection select the trial phase from the drop down menu and add the medical condition using the button add condition found on the right side in the pop-up window type the condition and indicate whether it is considered a rare disease or not using the tick box on the left side you can also add translation click on the confirm button scroll down and insert the therapeutic area using the drop-down list below insert the trial scope using the drop down menu you may insert multiple values in this example safety efficacy and therapy are selected below type the main objective in its respective field scroll down and click on the add inclusion criteria button in the pop-up window type the inclusion criterion on the available field click on the confirm button you may add more than one value in this subsection follow the same procedure to insert the appropriate exclusion criteria and primary end points scroll down and in the trial duration area use the calendars and insert the estimated recruitment start date and the end of trial date below in the subsection of the population of trial subjects insert the age range from the drop down list additional information in terms of gender and whether the subjects of the trial belong to vulnerable population or not can be provided below open the next subsection the clinical trial protocol and click on the add document button found in the protocol area either drag and drop the document on the grey area or click on the grey area to browse your files and select the document click on the attach button the remaining fields of this subsection are not mandatory this video is part of the ctis training program for more information on the structure and content of trial details subsection or of the remaining subsections for sponsors and products in part one section of a clinical trial...