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. You can extract questions from documents with the following classifications:
- Regulatory > Correspondence
- Clinical > Regulatory Support
- Nonclinical > Regulatory Support
- Quality > Regulatory Support
- Regulatory > Meeting Materials and Presubmission Details
- Regulatory > Multidisciplinary Info
- Regulatory > Multidisciplinary Info
- Regulatory > Request for Comments and Advice
- Regulatory > Request for Comments and Advice Other
- Regulatory > Response to Questions and Request for Information
Extract a Health Authority Question
To extract a health authority question from a document:
Navigate to Submission Mgmt > Library and open the document you want to extract a health authority question from.
Click the Health Authority Interactions icon.
Click Select Questions.
Highlight a question in the document. Each new highlight will create a new annotation entry in the Health Authority Questions section.
Respond to a Health Authority Question
To respond to a health authority question:
In the Health Authority Interactions pane, click a question identifier.
In the popup, select Change State to Ongoing from the Workflow menu.
Click Yes.
Click Edit (pencil icon).
Fill in the necessary details.
Provide your response to the question.
Click Save.
Select Change State to Closed from the Workflow menu.
Click Yes.
Health Authority Question Statuses
Health Authority Questions use the following statuses:
- Open: This status indicates that the Health Authority Question has been created but work has not yet been started.
- Ongoing: This status indicates that work has started on the Health Authority Question.
- Closed: This status indicates that all tasks for the Health Authority Question are completed and no further work is required.