How to Generate Critical Processes and Data with the Help of AI

To begin identifying study-specific Critical to Quality (CtQ) factors, follow the steps below using the Protocol Analysis Tool.

1. Navigate to the Protocol Analysis Tool within the relevant study.
2. Click Generate CTQ under Step 2 (see below).

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

3. To identify study-specific Critical to Quality (CTQ) factors, upload your Study Protocol in .docx or native (machine-readable) PDF format by:
   1. Clicking Choose file
   2. Selecting the desired protocol file
   3. Clicking Open.

4. (Optional) Choose a set of example CP&CD to support identification:

• Company CP&CD from MyRBQM (recommended if available)
• Predefined examples provided by the Cyntegrity team

5. Click Identify CTQ.

Note: Editing CP&CD on this page will not update the Company CP&CD.

6. Once the request is processed (usually within a few minutes), the requestor will receive and email with a link to the generated Critical to Quality Factors Report.

7. The generated Critical to Quality Factors Report contains a list of Critical Processes and a list of Critical Data. Edit the Title and Detail fields or delete entries (by clicking on its Trash Can icon) as appropriate.
8. From here you can:
   1. Download the finalized CP&CD
   2. Insert in MyRBQM Study CP&CD by clicking Insert in Study CP&CD (Newly inserted CP&CD will be added to existing ones.)
   3. Download:
      1. The original Protocol file
      2. The recognized protocol text
      3. The Log file(s)
9. Start a new request by clicking New Request. The CtQ generation process will start from the beginning.
   1. Previously generated (unedited) results are accessible any time via the original email link.

Important Notes:

• The AI model used for CtQ identification 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.