Content Overview
- How to create a Program
- How to navigate to the Dossier, Data Room, & Editor
- High level functionality summary for the Dossier, Data Room, & Editor
Programs house an individual drug program's source data, your AI drafts & edits, and enable collaboration & review. To begin drafting a dossier in Weave, you will first need to create a Program.
Process
Step 1: Creating a Program
Click Create a Program to get started.
Fill in the required information to configure your Program then select Create Program to finish set up.
Tips for configuration:
- Program Name: Enter a name following your organizational nomenclature (e.g., Drug Name).
- Template: Select Weave Baseline Template. Additional Documentation on template creation & customization can be found in this Knowledge Base.
- Description: Add details to define the Program.
- Stage: Defaults to Non-clinical; can be updated later.
- Note: Stage selection will not impact back-end configuration for the Program.
- Note: Stage selection will not impact back-end configuration for the Program.
Step 2: Navigating the Dossier
Navigate to your Program located on your Organizational Dashboard.
Upon selecting your Program, you’ll be redirected to the Dossier section.
- Dossier: Serves as the hub for drafting your submission. It provides a summary of drafting status and detailed view of the application.
- The “186 total documents” reflect the number of sections within the Dossier & the status of each is listed below.
- Folder Organization: The Dossier follows standard eCTD formatting. Click any Module to expand and view its components (see example below).
Step 3: Data Room – Source Documentation & Data Tags
Navigate to the Data Room to upload, manage, and understand your source documentation. You'll find features in the data room that will enable you to map your source files to your dossier as well as help you find information such as study protocols or even individual test values across your source material.
- The purpose of the Data Room is to store all Source Documents in one location to allow the AI to automatically summarize the content and apply metadata tags.
- Supported File Types: PDF, RTF, DOCX, XLSX
- To more effectively categorize and use source data for generation, each file in the Data Room contains Data Tags.
- Instead of generating entire sections with many source files, Data Tags enable content generation of individual parts of a section using only the most appropriate files or source sections as inputs.
- Essentially, content generation is based off of the documentation available in the Data Room; therefore, any content that shall be included in the Dossier must be available in the Data Room via a Source Document.
- Instead of generating entire sections with many source files, Data Tags enable content generation of individual parts of a section using only the most appropriate files or source sections as inputs.
Data Room Features:
Overview:
The overview tab will provide a table view of all uploaded source files, along with a summary of each document.
Files
The files tab is used to upload, store, and index source files.
- In-depth documentation on uploading & managing source documents can be accessed via this link.
To upload source files click Upload and select (or drag-and-drop) desired files or folders while in the Files tab.
- Folder structure will be maintained upon upload.
After uploading your files, the AI automatically processes each to extract metadata, generate summaries, and assign Data Tags.
Ask:
The Ask tab enables users to search the available source files via the AI.
Query the source data by selecting the “+” button and entering your question within the search box that appears.
- Users can set specific Source Documents or Data Tags for the AI to search by adding them to the grey bar within the text box.
Upon searching the Source Documents, the AI will return a response to your question & list of sources used to generate the content.
Step 4: Dossier - Navigation & Functionalties
Once Source Documents have been uploaded to the Data Room, navigate to the Dossier tab and select the Module you’d like to begin working on.
Open the sections of the Dossier by clicking on the arrow adjacent to the section of interest.
Select the function (e.g., View) within the Actions column that corresponds with the section of the Dossier you’d like to work on. This action will redirect you to the Editor tab.
To be redirected to the Template view of your section of interest, select the ellipsis (*** icon) and click “Open Template” within the pop-up that appears.
Actions Glossary:
- View: Content is not yet drafted & source documents are either not yet available or appropriately tags must be added.
- View Draft: Components of the section have been drafted & at least 1 section needs to be generated.
- Edit: All components have been drafted and SME review/updates may begin.
- Generate: Source documents have been detected for components of the section & the AI is ready to generate the content.
Step 5: Editor - Content Generation Basics
Once you’ve navigated to the Editor tab, you’ll be able to begin generating and refining content for your Dossier.
The back-end template for the section may be accessed by clicking on the Template icon.
- In-depth documentation on Template customization may be accessed via this link.
If source documents have been detected for a specific section, the block will be highlighted in green with text stating “Sources detected”. To draft the content, select Generate.
To verify which Data Tags & Source Documents will be used to generate the content for this section, select Review sources.
Within the pop-up below, which appears when you select Review sources, you may review & modify the specific Source Documents that will be used to populate the corresponding content.
If sources are detected for multiple sections (& you’ve verified the Data Tags are appropriate), you can generate content for all applicable sections at once with the Generate all content feature.
If Source Documents are not detected for a particular section, the block will be shaded grey with the Data Tag for the section listed in purple with a message stating “Sources needed”.
- You’ll see the view in the screenshot below if:
- Corresponding Source Documents need to be uploaded to the Data Room.
- Corresponding Source Documents are available, but applicable Data Tags need to be added.
- Corresponding Source Documents are available and Data Tags are applied, but the necessary information is missing from the document.
Once the applicable Source Documents are uploaded &/or Data Tags are added, the corresponding section will display the view above and users may generate the content.
