Complete Review Walkthrough

This guide walks you through a complete review from start to finish — from receiving a submission to signing off on your review. Follow these steps in order for your first review, and use it as a checklist for subsequent reviews.

Before You Begin #

Make sure you have:

• A Reviewer account with review permissions (see Getting Started)
• At least one dossier imported into the Dossier Library
• An understanding of which modules you are responsible for reviewing (e.g., M3 for CMC, M5 for Clinical)

Step 1: Start Your Review from the Dashboard #

1. Log into Reviewer. You land on the Dashboard.
2. Check the Pending Approvals and My Tasks cards. If someone assigned you a review, it appears here.
3. If you have a pending task, click it to jump directly to the relevant dossier and submission.
4. If starting a new review without an assignment, click Dossier Library in the sidebar.

Step 2: Open the Submission #

1. In the Dossier Library, find the dossier you need to review. Use search or filters if you have many dossiers.
2. Double-click the dossier to open the TOC view.
3. Check the submission selector at the top to make sure you are viewing the correct sequence (e.g., 0005 for the latest amendment).
4. If the submission status is “Draft,” click Change Status to move it to “In Review” (if your workflow requires this step).

Step 3: Review Documents by Module #

1. Use the module filter buttons (M1–M5) above the TOC tree to focus on your assigned module.
2. Expand the tree sections by clicking the arrows next to folder names.
3. Click a document (leaf node) to open it in the viewer.
4. Read the document. Use the PDF viewer’s zoom and search controls as needed.
5. When you find something noteworthy — an error, a question, or something that needs attention — create an annotation (see Step 4).
6. After reviewing a document, move to the next one in the tree.

Step 4: Annotate as You Review #

For every finding, question, or observation:

1. Select text in the document (or right-click in the document area).
2. In the annotation form:
   • Write a clear, specific note (e.g., “Table 3.2.S.4.1 — stability data shows trending toward shelf-life limit at 24 months. Confirm acceptance criteria.”)
   • Set the type — use Annotation for text notes, Highlight for “flag this section”
   • Set Assigned To if someone else needs to address this
   • Set Priority — High for blocking issues, Medium for corrections, Low for observations
3. Click Save.

Step 5: Check the Annotation Summary #

After reviewing all documents in your assigned module:

1. Look at the Annotations tab in the right sidebar panel.
2. Filter by Assigned By: (your name) to see all your annotations.
3. Review the list to make sure you did not miss anything.
4. Check the annotation count at the top of the panel.

Step 6: Run Reports (Optional but Recommended) #

Before finalizing your review, run relevant reports to get a structured view of the submission:

• Chronology Report — Verify the submission timeline makes sense. Are there gaps?
• Specification Dashboard (for CMC reviewers) — Check the Health Score and specification completeness.
• Correspondence Tracking — Review past agency interactions. Are there unresolved commitments?
• Labeling History — If reviewing a supplement, check what labeling changed.

Step 7: Export Your Review #

To share your review findings:

1. Go to the Annotations panel in the TOC view.
2. Click the Export icon to download all your annotations as a spreadsheet.
3. The export includes document name, page number, annotation text, type, priority, status, and assigned user.
4. Share this with your team or attach it to your review summary.

Step 8: Complete the Review #

1. Once all documents are reviewed and annotations are addressed, go back to the TOC view.
2. Click Change Status to advance the submission (e.g., “In Review” → “Review Complete” or “Approved”).
3. Add any final notes in the transition dialog if prompted.
4. The submission status updates and the review is recorded in the audit trail.

Review Checklist #