Submitted by Dan_Renninger on Mon, 04/20/2009 - 19:27.
In order to set up a new submission project you will first need to create a Product component (if one does not already exist). This can be done by right-clicking a parent component (i.e. Therapeutic Area) and then selecting Add>New Component. In the component dialogue, be sure to select a component type of Drug Product (or Project). Name the product appropriately and click finish. Beneath the product area, you must create a region component by adding component of the type region. In the Add Component dialogue, provide a category and name(s) for the region. Last, be sure to select ‘eCTD; in the field ‘backbone type’ and then click Finish. With the region now created right-click on the region and choose ‘Properties’. In the properties dialogue, choose the eCTD tab. In the field Submission Region, select the appropriate region for your application. If it is a US submission, select the option for STF 2.2 and click OK. Finally, within the region component add a component of type dossier. With this structure in place, you can then begin building a new sequence by utilizing the Import>Insert Component Package feature. Note: On the dossier component it’s a good idea to supply application level metadata on the eCTD tab so that common metadata cascades to all submissions in your application.
In order to set up a new submission project you will first need to create a Product component (if one does not already exist). This can be done by right-clicking a parent component (i.e. Therapeutic Area) and then selecting Add>New Component. In the component dialogue, be sure to select a component type of Drug Product (or Project). Name the product appropriately and click finish. Beneath the product area, you must create a region component by adding component of the type region. In the Add Component dialogue, provide a category and name(s) for the region. Last, be sure to select ‘eCTD; in the field ‘backbone type’ and then click Finish. With the region now created right-click on the region and choose ‘Properties’. In the properties dialogue, choose the eCTD tab. In the field Submission Region, select the appropriate region for your application. If it is a US submission, select the option for STF 2.2 and click OK. Finally, within the region component add a component of type dossier. With this structure in place, you can then begin building a new sequence by utilizing the Import>Insert Component Package feature. Note: On the dossier component it’s a good idea to supply application level metadata on the eCTD tab so that common metadata cascades to all submissions in your application.