Extract a Health Authority Question from a Document

As submissions are sent to the Health Authority, they may require you to provide answers to questions. In Veeva RIM Basics, you can manage communication with Health Authorities by tracking incoming questions and responses, and track the status of each individual question/response. To make this process easy, you can extract questions from existing documents.

To extract a health authority question from a document:

1. Navigate to Submission Mgmt > Library and open the document you want to extract a health authority question from. It must be classified as one of the classifications under Regulatory Correspondence.

2. Click the Health Authority Interactions icon.

   

3. Click Select Questions.

   

4. Highlight a question in the document. Each new highlight will create a new annotation entry in the Health Authority Questions section.

   

To respond to a health authority question:

1. In the Health Authority Interactions pane, click a question identifier.

   

2. In the popup, select Change State to Ongoing from the Workflow menu.

   

3. Click Yes.

   

4. Click Edit (pencil icon).

   

5. Fill in the necessary details.

   

6. Provide your response to the question.

7. Click Save.

   

8. Select Change State to Closed from the Workflow menu.

   

9. Click Yes.