Watch: How to manage a health authority question from upload to Create Response
Note: The Data Room must be set up before you click Create Response. When Create Response runs, the platform searches the Data Room for relevant source files. An empty or incomplete Data Room means a low-quality first draft regardless of how well the question is configured. [→ Set up the Data Room first: see the Data Room Guide]
You also need the HAQ Contributor role or higher to upload and assign questions. If you can see HAQ Manager but can't upload or assign, contact your administrator.
What HAQ Manager Is
Teams receiving an IR from a health authority have historically managed questions in spreadsheets, tracking question text, ownership, status, and due dates across email threads and shared drives. HAQ Manager replaces that spreadsheet with a managed workspace where every question has a home, and every action is linked to a specific query.
The critical shift: when you set up a question correctly, right team, right sources, right template instruction, the AI generates a substantive first draft. When questions are set up carelessly, the output is generic. HAQ Manager is not just a tracking tool. It is the quality-control checkpoint for everything that comes after it.
Step 1: Upload the IR question file
When an IR arrives from the health authority, upload the question file into HAQ Manager.
- Open your program in Weave and navigate to HAQ Manager
- Click the Upload question file icon
- Upload the question file from the health authority — PDF or DOCX
- Weave extracts the question text from the file automatically
Important: Decide who uploads before the IR arrives — not after. Unassigned uploads cause delays that cascade through the entire response timeline.
Step 2: Review the extracted question text
After upload, verify the extraction before doing anything else.
Check:
- Does the question text match exactly what the health authority asked?
- Are multi-part questions clearly separated? If a question has sub-parts A, B, and C, confirm all three are captured.
- Is the question ID correct?
If the extraction looks correct, click the Verify icon in the expanded preview to mark the question as reviewed. If anything needs editing, fix it in the field first, then verify.
Note: Tables embedded in the question file are not currently extracted — only the text portion. If the health authority's question includes a data table that is part of the question itself, paste the table content into the template instructions so the AI can work with it. This is a known limitation on the roadmap for improvement.
If the extraction is incorrect or incomplete, edit the question text directly in the field before proceeding.
Step 3: Complete the question metadata
Before assigning your team or clicking Create Response, fill in the metadata fields. These are not optional, they affect how the question routes, who receives it, and how it appears in the tracking view.
- File rename: Rename the uploaded file to your program's standard naming convention (IR number + question descriptor). Don't leave it as the health authority's default file name.
- Question ID: Confirm or edit the extracted identifier to match your program's internal numbering.
- Category and discipline: Assign the regulatory category (CMC, Clinical, Nonclinical) and functional discipline.
Important: Category and discipline must be accurate. Questions with wrong or missing categories may appear in the wrong team's queue, delay assignment, and produce irrelevant Similar Questions matches.
Once the metadata is complete, you're ready to assign your team.
Step 4: Assign authors, reviewers, and approvers
Assign all three roles before authoring begins.
- Author: The person responsible for generating and drafting the response in the editor
- Reviewer: The person responsible for scientific and regulatory review of the draft
- Approver: The person responsible for final sign-off before export
Tip: The person writing the template instruction may or may not be the author listed here. If the GRL or functional lead is responsible for translating strategy into template instructions, make that assignment explicit — either as the named author or as a named pre-authoring task at your alignment call.
Set the due date at this stage. If your program tracks authoring, review, and approval at the step level, document those interim dates in the notes field.
Step 5: Hold the alignment call
Before clicking Create Response, hold the alignment call with your team.
The alignment call is where:
- Authors confirm they understand the question and the health authority's concern
- The regulatory strategy lead sets the approach — key messages, precedent, format
- Source files are identified and confirmed by the relevant SME
- The template instruction is drafted or assigned to a named person
Important: Do not click Create Response before the alignment call or before source files have been reviewed by an SME. Create Response locks in the initial AI source selection as the baseline. If the wrong files are selected at this stage, the author must correct them manually — after the fact and under time pressure.
If your timeline requires uploading and extracting the question before the alignment call, that's fine. Just stop before clicking Create Response until the alignment call is complete.
Step 6: Verify source files before clicking Create Response
In the question panel, open the Source Files section. Review the files the system has identified as relevant to this question.
Each file shows:
- File name
- Folder path within the Data Room (jurisdiction, submission, module)
- Relevance indicator: High, Medium, or Low
An SME who knows the relevant source documents should review this list.
Tip: Give SMEs the HAQ Contributor role so they can review and adjust source files in the panel before Create Response is clicked. Alternatively, hold a brief source review session with the SME immediately after the alignment call.
The relevance indicator is relative — a "Medium" file may still be the correct source if it's the best available match for this question.
Once source files are confirmed, you're ready to create the response.
Step 7: Click Create Response
Once the alignment call is complete, source files are confirmed, and the template instruction has been assigned or drafted, click Create Response.
This creates the response document in the editor and triggers the AI to assemble a first draft based on the template instruction and the selected source files. The author will now see the question in their authoring queue.
Note: Clicking Create Response before source files are verified and the template instruction is set is the single most common upstream quality issue. The draft that results from a premature Create Response is generic and often erodes the team's confidence in the platform.
Step 8: Track status and monitor progress
After Create Response, the question moves through statuses as the team works: authoring → review → approval → export.
Monitor status in the HAQ Manager queue. If a question has been in a status for longer than expected, check with the assigned team member directly — the platform tracks status but does not send automated reminders.
Tip: If your team maintains an external tracking spreadsheet alongside HAQ Manager, that's a signal there are fields or views you need that aren't yet in the platform. Note what you're tracking externally and share it with your customer success contact — these gaps directly inform the HAQ Manager roadmap.
Step 9: Attach the submitted response file
Once the final response has been submitted to the health authority, return to HAQ Manager and attach the final submission file to the question.
- Open the question in HAQ Manager
- Navigate to the Submitted Response Files section in the question panel
- Use the Data Room file browser to locate and attach the response document
Attach the main response document only, not cover letters, literature references, or Module 3 updates.
Important: Submitted response files in the platform are manually attached and may be incomplete. They are a reference tool for future similar questions, not a replacement for your organization's DMS as the authoritative submission record. Always retrieve definitive submitted documents from your DMS.
This step feeds the Similar Questions feature, future questions that resemble this one will surface it as a match, and team members can click through to the associated response document.
Notes, hyperlinks, and timeline tracking
The HAQ Manager notes field accepts plain text and is useful for strategy notes, key messages, and tracking references. A few current limitations to know about:
- No hyperlink support: The notes field doesn't render clickable links. Teams that reference prior submissions or external documents during alignment calls typically maintain a separate shared document for this.
- Single due date only: HAQ Manager supports one due date per question. Programs tracking authoring, review, and approval at the step level with hour-level precision typically supplement this with an external timeline document.
- Multiple TDNs: For programs submitting in multiple languages (Japan, China), record multiple tracking document numbers in the notes field using a consistent format — one per line.
FAQ
Q: Can the same person be both the uploader and the author?
Yes. In smaller programs or for less complex queries, this is common. The distinction matters at scale — in programs with multiple functional areas and many simultaneous IRs, clear role separation prevents questions from going unassigned.
Q: What happens if I click Create Response before the alignment call?
The AI generates a first draft based on whatever source files it has identified and the default template instruction — which is a verbatim copy of the health authority's question. The draft will be generic and will require the author to start largely from scratch. It's not catastrophic, but the quality of the first pass will be noticeably lower.
Q: Why isn't the Similar Questions panel showing questions I'd expect?
The Similar Questions panel matches based on question semantics. If expected matches aren't appearing, report the specific question pair to your customer success contact. User-reported mismatches directly improve the matching algorithm.
Q: Can external partners or CRO collaborators access HAQ Manager?
External partners not on your organization's SSO cannot log in directly. The recommended workaround is to provision them with a proxy organizational email address — this requires coordination with your IT team and the Weave team. Platform access is SSO-only.
Q: Can I see questions from other programs to reference strategy precedent?
By default, programs are siloed and you can only see questions within your assigned programs. If cross-program read access is needed, the HAQ Viewer role can be assigned with authorization from your GRL or equivalent senior leadership. Cross-program access requires explicit approval given the confidential nature of pre-approval regulatory data.
Quick Reference: Managing a question in HAQ Manager
Setup (before alignment call):
- Upload the IR question file → verify extraction is accurate
- Rename the uploaded file to your standard naming convention
- Confirm or edit the question ID
- Assign category and discipline
- Assign author, reviewer, and approver; set due date
Before clicking Create Response:
6. Hold the alignment call — confirm strategy, identify sources, assign template instruction author
7. Review source files in the question panel with an SME
8. Confirm source files are correct
After authoring:
9. Monitor status as the author → reviewer → approver cycle runs
10. After submission: attach the final response document using Submitted Response Files