TSR Report generation (with GenAI to identify and request missing data)

Purpose

TSR Report generation (with GenAI to identify and request missing data) helps identify gaps in study report data and supports completion of technical study reports for FDA IND filing. It uses known FDA guidance on what a TSR should contain and avoids assumptions by prompting the user when required information is missing.

Primary users

The primary user is a scientific writer who receives raw data from a testing lab and needs to complete a technical study report for regulatory filing. Other users are not specified.

Where it fits (process/stage/trigger)

This agent fits after lab data and related study information have been received and before the technical study report is finalized for FDA IND filing. The process is triggered when the user uploads available lab data and other information to generate the TSR in the proper format.

Key capabilities / workflow

The agent analyzes the provided lab data and supporting information against TSR content expectations, identifies gaps in the dataset, requests missing information from the user, and generates the technical study report once the required information is complete. It does not assume unknown required details and prompts the user when information is incomplete.

Inputs

Typical inputs include raw data from a testing lab and other user-provided information needed to generate the TSR. Specific input templates, datasets, and required source formats are not specified.

Outputs / Deliverables

The expected outputs are a technical study report in the proper format for FDA IND filing and queries or prompts requesting missing information when the provided data is incomplete. Additional output formats are not specified.

Value

The agent helps scientific writers complete TSRs more consistently by identifying missing data early, reducing the risk of unsupported assumptions, and guiding users toward the information needed for a complete study report aligned with FDA expectations.