How to Create a Risk Assessment with the Help of AI

To start with AI-Enhanced Risk Assessment generation, proceed to the Protocol Analysis Tool page and click Generate Risk Assessment (in Step 3, below).

For detailed instructions on how to access the tool, refer to the article: How to Enable and Access the Protocol Analysis Tool.

To Generate a Risk Assessment:

1. Upload a protocol in .docx or native PDF formats.
   1. Note that PDFs containing scanned pages or text stored as images will not be processed.
   2. Other restrictions applicable to the uploaded file can be found by clicking Learn more about text processing limitations.
2. When the protocol file is successfully uploaded, click Generate Risk Assessment.

3. Once the request is processed, the user will receive an email with a link to access the result (see example below). Note: Receipt of this email may take a few minutes, depending on the size of the protocol.

4. Click the link in the email to navigate to the generated Risk Assessment, consisting of the list of Risk Statements in the "if-due to-then" format.
   1. Each Risk Statement has an associated Risk Question and an allocated Risk Category from the TransCelerate Categories List.
   2. Here, you can edit the Risks by:
      1. Selecting a Risk Category from the drop-down list
      2. Editing the Risk Question
      3. Editing the Risk Statement
      4. Deleting the Risk entirely
5. Edit all Risks in the Risk Assessment as needed.
6. When all edits have been made, insert the Risk Assessment into RACT by clicking Insert in RACT. (The newly identified risks, risk questions and risk categories will be added to the existing ones in your RACT).
7. To download:
   1. The uploaded Protocol file, click Download [Protocol name].
   2. The recognized protocol text, click Download Recognized Protocol text.
   3. The Log file(s), click Download Log file.
8. To start a new request, click New Request. The Risk Assessment generation process will start from the beginning.
   1. Unedited results of any previous request can be accessed using the link in the email.

Important Notes:

• The artificial intelligence (AI) model used for Risk Assessment is based on Microsoft Azure OpenAI's GPT technology.
• It is designed to generate human-like responses to text prompts based on recognized patterns and correlations found in large datasets.
• It is not a subject matter expert (SME) and should not replace human professional judgment.
• All AI-generated results should be validated by qualified professionals and interpreted with caution.
• No study data is used to train the AI model. Your uploaded content remains confidential and secure.