The Projects Page is where you will see all the projects you created or were assigned. You can only create projects with the following roles: System Admin, Principal, and Creator. Users can only view assigned projects.
The Project Workspace provides a streamlined platform for managing your documents, organizing resource files for your project, and viewing and adding sources, attributes, prompts, and team members.
Documents
A project is linked to a unique set of sources and their corresponding documents.
Type
During the document creation process, a wide variety of document types are available to choose from, each tailored to meet the specific requirements of your project. For all available document types, there is a corresponding Template Picklist that offers a selection of options relevant to the document type.
Templates
CoAuthor combines eCTD templates and macros within Word, enhanced by AI functionalities to streamline regulatory document creation and management.
None
The 'None' option in the Template Picklist allows the writer to forego the template selection process, providing the freedom to create and develop a document from scratch without the constraints of a predefined template.
Select File
The 'Select File' option within the Template Picklist streamlines the workflow for writers by allowing them to directly upload a document from their local storage or file system.
đĄPro Tip - Client-generated templates can be used in CoAuthor by choosing Select File, then selecting the template from your local file or folder.
đ Pro Tip - Users are not permitted to open or modify templates directly; however, they can create documents from these templates and then edit those documents as needed.
Sources
The Sources Tab contains all the essential supporting documentation required for document creation and authoring. For a CSR, this includes Analysis Ready Datasets, Datasets, Protocols, Statistical Analysis Plans, Tables, Listings, and Figures.
Attributes
Attributes play a crucial role in managing your digital data flow and will maintain consistent naming throughout. They are vital components, whether they pertain to your exploratory endpoints, primary objectives, secondary objectives, or organizational identifiers.
Attributes can be filled in manually, which permits direct editing and entry of values, or they can be automatically populated when a protocol document is loaded and activated or an attribute document is loaded.
Prompts
The Prompts Tab offers a versatile workspace for crafting custom prompts that cater to the unique requirements of each project. These tailored prompts support a dynamic flow of information, allowing for repeated use across projects to enhance efficiency.
TASK
There are 3 options to select from the "TASK" menu when creating a prompt.
Free Text
The "Free Text" feature enables you to pose questions in an unstructured text format.
Summarization
The "Summarization" task is designed to condense the content of a chosen attachment, integrating the condensed text seamlessly into the document at the prompt macro's location.
Past Tense
The "Past Tense" task is aimed at converting a chosen attachment into the past tense, ensuring the modified text is smoothly incorporated at the designated prompt macro spot in the document.
Members
CoAuthor enables the management of user permissions at the Project level, allowing for the assignment of specific permissions for actions within it. Additionally, users can be assigned to specific or all documents on an "as needed" basis.
Add Team Member
To assign a team member to a project, click the "Add Team Member" button. This action will display a list of users from within the system. From this list, you can select an individual to add to the project.
Edit Members
Click the checkbox under "Edit Members" to permit the member to edit members for the project.
Edit Sources
The "Edit Sources" option allows users to modify the information in the "Sources" tab.
Edit Documents
The "Edit Documents" option provides the capability to choose the document(s) each user can access.
Remove
Members should be removed from projects based on necessity.
Utilizing CoAuthor and assigning your team to your projects allows you to co-author documents effectively and efficiently with ease.




















