Get answers to common questions about using CoAuthor with different modules, templates, and source documents. Below, you'll find helpful information to assist you in navigating the tool and optimizing its features for your needs.
Is CoAuthor compatible with CMC modules?
Yes, CoAuthor can be used with CMC modules, providing a seamless experience across various module types.
Are there any special considerations for using CoAuthor with Module 3 documents?
No, CoAuthor functions consistently across all submission modules, including Module 3, with no additional setup or configuration required.
Modules 2.5 and 2.7
Can all sections of Modules 2.5 and 2.7 be generated using the Certara tool?
Yes, all sections can be generated using CoAuthor. However, custom solutions may be required depending on the complexity of sources or desired output.
What source documents are required for generating Module 2.5 and 2.7 documents?
The same documents that a writer would need to author these documents are required. They do not need to follow a strict structure and will be accepted in the following formats: csv, docx, pdf, rtf, sas7bdat, xlsx, xpt, zip.
Are there any limitations when using CSRs as source documents?
No limitations exist when using CSRs as source documents. However, the model will only have access to data explicitly described in the CSR. Users may need to upload raw data/CSR sources if referenced information is not explicitly stated in the CSR.
Can all types of Module 2.7 documents be generated using the tool?
Yes, both external literature references (bibliographic) and internal/CRO study reports can be used as sources provided they are in one of the accepted formats.
Do users need to specify which source documents should be used for each section?
Yes, sources need to be defined per prompt. Users can bulk edit sources using the 'Manage Sources' feature.
Can multiple templates be used with the tool?
Yes, any template can be used as a starting point. Users will need to copy prompts from the previous template to the new template if switching between templates.
Note: These FAQs are based on available information and may not cover all possible scenarios or questions related to using the Certara tool for generating Module 2.5 and 2.7 documents.