Extract a Commitment from a Document

As a condition of approving a pharmaceutical product to be marketed, or approving changes to the products, a Health Authority may require changes to a Submission, or require that additional information be provided in areas such as safety, efficacy or optimal dosage. These are regulatory commitments.

To make this process easy, you can extract commitments from existing documents. You can extract commitments 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

Create a Commitment

To create a commitment:

1. Navigate to Submission Mgmt > Library and open the document you want to extract a commitment from.

2. Click the Health Authority Interactions icon.

   

3. Click Select Commitments.

   

4. Select text in the document. Each new selection will create a new annotation entry in the Commitments section.

   

Work on a Commitment

To work on the tasks needed for the commitment:

1. In the Health Authority Interactions pane, click a commitment 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, including assigning a Commitment Owner and Due Date. The document you extracted the commitment from is automatically attached to the commitment.

6. Click Save.

   

Close a Commitment

When the commitment has been fulfilled, you can close it.

To close a commitment:

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

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

   

3. Click Yes.

   

Commitment Statuses

Commitments use the following statuses:

• Open: This status indicates that the Commitment has been created but work has not yet been started. 
• Ongoing: This status indicates that work has started on the Commitment.
• Closed: This status indicates that all tasks for the Commitment are completed and no further work is required.

Edit a Commitment

1. Navigate to Submission Mgmt > Health Authority Questions > Commitments and select a commitment.
2. Click Edit ().
3. Update the commitment information as needed. 
4. Click Save.

Remove a Correspondence from a Commitment

1. Navigate to Submission Mgmt > Health Authority Questions > Commitments and select a commitment.
2. Open the Correspondence section and click Add.
3. Uncheck the document(s) you want to remove and click Close.

Delete a Commitment

Before you can delete a Commitment, you must first remove any correspondence documents from the commitment.

1. Navigate to Submission Mgmt > Health Authority Questions > Commitments and select a commitment. 
2. Select Delete from the All Actions menu.
3. Click Continue to confirm.