Pharmacovigilance templates
Start a DSUR, PBRER/PSUR or EU RMP outline with source anchors. One free input set; no signal detection, benefit-risk finding or submission.
What this is not: a clearance, approval, consent, signed record or submission. Responsible professional review is required. Jurisdiction: ICH development / marketed products; EU RMP.
Structured information
Only de-identified, non-confidential information. No names, birth dates, contact details or patient record numbers. Examples are synthetic.
Provider: local deterministic template engine; no AI call or document upload. Inputs and drafts remain in this tab’s memory; reload clears them. Only the allowance and input hash are stored in your browser. Copy or download before leaving. Not a controlled clinical record system.
Build the supporting evidence
Copy or download your draft first. Signup opens the AnswerThis app and does not transfer this result.
How to use this workspace
- Choose the document and confirm its jurisdiction and institutional owner.
- Enter structured information or load the synthetic example, then confirm the de-identification attestation.
- Generate the outline and complete the unfinished prompts in the editor.
- Review the result with its responsible owner and export it into the controlled project workflow.
What to check
- Source edition and local applicability are distinct from the date of your document.
- Use only supported facts; a blank does not establish a negative finding.
- Keep identifiers, population, document versions and evidence consistent.
- Review drafts in the responsible institution’s controlled system before use.
Select the correct safety document
The three options address different safety-document purposes. A DSUR is a development safety update report anchored to ICH E2F. A PBRER/PSUR working outline uses ICH E2C(R2) for periodic marketed-product benefit-risk evaluation. The EU RMP option uses GVP Module V for a product-specific risk-management plan. They may draw on overlapping information, but they are not interchangeable reports and cannot be produced by changing a title.
Identify the product scope, responsible sponsor or marketing authorisation holder, jurisdiction, document version and reporting period before generating. The page does not calculate a submission deadline, determine an EU reference date or identify which products can share a report. Those decisions belong to the responsible pharmacovigilance process. For a marketed product undergoing further development, confirm which development and post-authorisation obligations apply rather than assuming that one document replaces another.
The synthetic example contains only public-style metadata. Do not paste case listings, unredacted safety narratives, confidential signal assessments or patient identifiers here. Document-level periods are allowed, while patient calendar dates and case source records are outside the public workspace. The final report will need substantially more reviewed evidence than these starting metadata fields contain.
Populate the report with reviewed evidence
The DSUR structure provides prompts for reporting context, trials and exposure, findings from different evidence sources, an integrated safety assessment and conclusions. Assemble the underlying inventories and analyses in the approved safety environment. An empty literature or nonclinical section is not a conclusion that no new information exists. Reconcile the period, coverage and late-breaking information under the responsible team’s procedures before drafting a final assessment.
The PBRER/PSUR structure separates exposure and safety summaries from signal evaluation, benefit evaluation and integrated benefit-risk assessment. The tool does not detect signals, perform aggregate analyses or weigh benefits against risks. It only creates the places where accountable reviewers can document that work. EU PSUR requirements and submission mechanics require a separate check of current EMA guidance and the product’s applicable schedule.
The RMP structure separates safety specification, pharmacovigilance activities, post-authorisation efficacy work, risk-minimisation measures, a summary and annexes. Each activity needs a clear link to the safety concern it addresses and the applicable governance decisions. Listing a proposed measure does not show that it was implemented or effective. Keep evidence of effectiveness evaluation, milestones and responsible review in the controlled risk-management process.
Preserve review status and traceability
Every section links to an authoritative anchor and names the edition used for this authoring outline. The prompts are original concise summaries, not a complete official template. Check the current agency instructions and any product-specific requirements before using the structure for a real report. The source-review date describes this page’s editorial review; it is not the data lock point of your safety evidence or a declaration that a newer regional requirement cannot exist.
Generate one option, then switch to another for the same metadata without consuming another successful run. Keep the outputs distinct and review differences in scope, periods and evidence. The browser does not harmonise completed sections across report families, calculate cumulative exposure or maintain a safety database. Missing values remain [To be completed], and the generated outline provides no medical sign-off, quality approval or submission receipt.
Copy and download are free for the existing draft. The deterministic template engine runs locally without an AI provider; exports can be edited in your document workflow and retain the draft warning. Have the appropriate pharmacovigilance, clinical and regulatory owners reconcile the finished material with source records before approval. Signup opens the separate AnswerThis app, adds no runs to this page and does not transfer the draft. Use the official reporting or submission channel for the completed document.
Sources, versions and jurisdiction
Jurisdiction: ICH development / marketed products; EU RMP. Source review as of 2026-09-14. Source retrieval: 2026-09-13T22:50:11Z (editorial review, not a live document lookup). No agency endorsement. Original concise outlines with links; source documents remain the work of their respective owners. ICH materials © ICH; prompts are adapted summaries, not official templates.
- ICH E2F — 2010-08-17
- ICH E2C(R2) — 2012-12-17
- EMA GVP Module V Rev 2 — 2017-03-28
EU periodic-report requirements: EMA PSUR guidance and submission information. Confirm the current EMA RMP templates before preparation.
Frequently asked questions
Should I choose DSUR, PBRER/PSUR or RMP?
A DSUR organises development-period safety review; a PBRER evaluates periodic benefit and risk for marketed products; an EU RMP plans risk management. For example, an investigational programme may need a DSUR while an authorised product has separate periodic reporting and RMP obligations.
How do reporting periods and birth dates differ?
Record the interval and data lock point separately from the report date. DSUR context uses the development international birth date; PBRER context uses the international birth date. This tool does not calculate a submission deadline.
Is an ICH PBRER automatically an EU PSUR submission?
No. ICH E2C(R2) supplies the benefit-risk outline; EU PSUR requirements, schedules and submission procedures require separate checking.
Which RMP edition and jurisdiction does this use?
The RMP is anchored to EMA GVP Module V Revision 2, including additional EU requirements and a safety-concerns summary. Confirm the current EMA template and the applicable authority’s requirements before completing annexes.
Can I enter patient records or confidential information?
No. Use only de-identified, non-confidential information. Do not enter names, birth dates, contact details, record numbers, signed forms or source records. The tools do not de-identify records for you.
How many free runs are included?
This page includes one successful free input set per browser. Failed requests and re-exporting a result are free. Subtemplates share the allowance; the same inputs can be used across them freely.
Does signup transfer my work or unlock more page runs?
Signup opens the AnswerThis app. It does not unlock more runs here or transfer your draft. Copy or download the result first.