HTA / Regulatory Dossier Templates

HTA and regulatory submissions demand more than a PRISMA 2020 systematic review. Each agency has its own required section tree, evidence hierarchy, and reporting conventions. EvidAI ships dossier-grade templates for the four most common agency formats and wires them into both the manuscript editor and the export bundle.

Supported Templates

NICE Technology Appraisal (UK)

The NICE Evidence Submission Template (current framework) — structured around:

• Decision problem framing (PICO + comparators + outcomes)
• Clinical effectiveness systematic review
• Indirect and mixed treatment comparisons
• Adverse events and safety
• Economic evidence (cost-effectiveness, cost-utility)
• Budget impact

CADTH Common Technical Manuscript (Canada)

The CADTH Reimbursement Review framework:

• Submission summary
• Evidence review (clinical + economic)
• Patient-informed evidence
• Implementation considerations
• Reviewer deliberations (where applicable)

IQWiG Dossier Evaluation (Germany)

The G-BA / IQWiG benefit assessment dossier:

• Module 1 (general information)
• Module 2 (indication and reimbursement population)
• Module 3 (comparator, clinical benefit, costs)
• Module 4 (clinical evidence — RCT evidence, indirect comparisons)
• Module 5 (studies not completed, studies outside the benefit assessment)

ICH M4E(R2) Clinical Overview (Global)

The ICH Common Technical Document (CTD) Module 2.5 clinical overview:

• Product development rationale
• Overview of biopharmaceutics and clinical pharmacology
• Overview of clinical efficacy
• Overview of clinical safety
• Benefits and risks conclusions
• Literature references

How to Activate a Dossier Template

Step 1 — Pick the matching reporting profile

Every review has a Reporting Standard profile that drives which checklists, templates, and bundle contents apply. To access:

1. Open the review (/slr).
2. Click the Reporting Standard selector in the hub header.
3. Choose a profile:
   • HTA dossier → activates NICE, CADTH, IQWiG templates
   • ICH M4E + EMA RWE → activates ICH M4E(R2) template

The selected profile is saved against the review and triggers a Reporting profile selected audit event.

Step 2 — Apply the template to your manuscript

1. Open the manuscript editor (/slr/manuscript).
2. Go to the Settings tab.
3. The Agency dossier selector appears (visible only when an HTA or ICH profile is active).
4. Choose a template (NICE / CADTH / IQWiG / ICH-M4E). The manuscript section list is pre-filled from the template's required-and-optional tree, with guidance notes inline.

Step 3 — Export

When you run the export bundle, a dossier directory ships alongside the usual PRISMA, audit, and reviewer-notes artifacts:

• A NICE TA dossier outline (or matching agency template)
• A CADTH submission dossier outline
• An IQWiG dossier outline
• An ICH M4E clinical overview outline
• A README that indexes every attached outline with its agency pointer

Per-Agency Checklists

Alongside the template, each profile activates an agency-specific checklist in the reporting-checklists engine:

• NICE HTA — NICE submission completeness
• CADTH HTA — CADTH submission completeness
• IQWiG HTA — IQWiG dossier completeness
• ICH M4E — ICH Module 2.5 completeness

Checklists are emitted to the bundle as Markdown, JSON, and CSV, with per-item status (complete, partial, missing) derived from the review's phase signals and attached artifacts.

Selecting the Right Template

You can attach multiple templates within the same profile — e.g. an HTA submission that targets both NICE and CADTH simultaneously. Each template renders its own dossier file in the bundle.

Governance Notes

• Templates are versioned with the platform — updates ship via standard product releases, not runtime configuration.
• Dossier selection is audited — every change to the manuscript's attached template is captured in the review's audit trail.
• Design is intentionally minimal — the dossier picker uses the same UI vocabulary as the existing Target Journal selector to keep cognitive load low.