Create New REMS Document

Below are examples of some of the screens you will see when using SPLServer to create a Risk Evaluation and Mitigation Strategies - REMS document. This does not include every step necessary to create and/or edit an SPL REMS document. You should request a full demonstration to see all of the capabilities of this software service.

After creating your REMS document, you enter the title and sponsor information as well as the Setid(s) for the related documents that you are creating this REMS for.



You can then enter the Product Information including the Marketing Authorization Holder.



Your REMS document will require you to enter Summary, Protocol, Requirements and Materials information. Below is how you start your Summary by adding sections, then selecting a section type and entering a header.



From the Summary screen for each section, you can choose to edit the Protocol information for that section. You add Protocols and select the Protocol type for each one. Here is where you also enter the Approval Code and Date.



From the Protocol screen for each Protocol, you can choose to add or edit the Requirements for that Protocol. For each Requirement, you choose the type, then a possible pause value in hours, minutes, days, months etc. You then select whether this Requirement is to be performed before, during or after the substance administration. You can then enter a repeat value in hours, minutes, days, months etc., as necessary. You can also associate previously added Materials that were created using the Materials screen.



The Materials screen is where you enter all of your REMS Materials as PDF documents. You add a Material document by entering it's description, then uploading the appropriate PDF document to the server. These are the documents that can be associated with the various Requirements as shown previously.



Once you have entered all of the required information shown previously, you can create the narrative portion of your document that will look like this.



You click on a narrative table to edit is as shown in the following example. You enter your text, then select it. You then click on the summary link button to pop up a list of links to requirements. Select the one you want to link and repeat for each one.