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Adverse Event Reporting Policy

Draft FDA-Compliant Adverse Event Policies in Minutes

12 minutes with CaseMark

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Adverse Event Reporting Policy

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Workflow

Adverse Event Reporting Policy

Overview

Creating comprehensive adverse event reporting policies requires extensive research across FDA regulations, eCFR citations, and industry best practices. Regulatory attorneys spend hours cross-referencing 21 CFR 312.32, 314.80, and related guidance documents while ensuring every section meets compliance standards and organizational needs.

Creating comprehensive adverse event reporting policies requires extensive research across FDA regulations, eCFR citations, and industry best practices. Regulatory attorneys spend hours cross-referencing 21 CFR 312.32, 314.80, and related guidance documents while ensuring every section meets compliance standards and organizational needs.

CaseMark automates the entire drafting process by intelligently researching FDA regulations, pulling relevant definitions from your uploaded documents, and generating fully structured policies with proper citations. What once took days of regulatory research and drafting now takes minutes, with built-in compliance checks and industry-standard formatting.

How it works

  1. 1. Upload your documents

  2. 2. AI analyzes and extracts key information

  3. 3. Review and customize the generated content

  4. 4. Export in your preferred format (DOCX, PDF)

What you get

  • Introduction

  • Definitions

  • Scope

  • Responsibilities

  • Reporting Procedures

  • Investigation and Follow-Up

  • Training and Awareness

  • Recordkeeping and Auditing

  • References and Appendices

What it handles

  • Introduction

  • Definitions

  • Scope

  • Responsibilities

  • Reporting Procedures

  • Investigation and Follow-Up

  • Training and Awareness

  • Recordkeeping and Auditing

  • References and Appendices

Required documents

  • Existing Compliance Policies

    Current organizational policies, SOPs, or compliance frameworks to ensure consistency with existing procedures

    .pdf, .docx, .txt

  • Organizational Structure Documents

    Information about roles, departments, and reporting hierarchies to accurately assign responsibilities

    .pdf, .docx, .xlsx

Supporting documents

  • Previous Incident Reports

    Historical adverse event data to inform investigation and follow-up procedures

    .pdf, .docx, .xlsx

  • Training Materials

    Existing training documentation to integrate with new policy requirements

    .pdf, .docx, .pptx

  • Industry-Specific Guidelines

    Specialized regulatory guidance for your specific therapeutic area or device category

    .pdf, .docx

Why teams use it

Generate complete 9-section policies with FDA-compliant language and proper regulatory citations

Automatically research and cite current regulations from 21 CFR 312.32, 314.80, and eCFR

Reduce policy drafting time from 6+ hours to under 15 minutes

Ensure consistency with organizational documents through intelligent RAG analysis

Include industry best practices from NCBI, ACOG, and FDA guidance automatically

Questions

How does CaseMark ensure my adverse event policy complies with current FDA regulations?

CaseMark automatically searches official FDA resources, eCFR databases, and regulatory guidance to incorporate the latest requirements from 21 CFR 312.32 and 314.80. The platform cross-references multiple authoritative sources and includes proper citations, ensuring your policy reflects current compliance standards without manual research.

Can I customize the policy to match my organization's specific procedures?

Yes. CaseMark analyzes your uploaded compliance documents, SOPs, and organizational structure to tailor the policy to your specific context. The platform integrates your existing terminology, reporting hierarchies, and internal procedures while maintaining FDA compliance requirements.

What's included in the reporting procedures section?

The reporting procedures section details detection, documentation, and submission steps with specific timelines like the 15-day reporting requirement for serious adverse events. CaseMark pulls standard formats from FDA guidelines and structures procedures according to regulatory best practices, ensuring nothing is missed.

How long does it take to generate a complete adverse event reporting policy?

CaseMark generates a comprehensive, citation-rich policy in approximately 12 minutes. This includes all nine sections with regulatory references, definitions, procedures, and appendices—a process that typically takes regulatory attorneys 6-7 hours manually.

Does the policy include definitions specific to my therapeutic area?

Yes. CaseMark uses RAG technology to search your uploaded documents for context-specific definitions while verifying them against legal sources like eCFR. This ensures definitions are both compliant and relevant to your specific clinical trials, devices, or pharmaceutical products.

What training and recordkeeping requirements are covered?

The policy includes comprehensive sections on employee training requirements and document retention periods based on FDA guidelines and eCFR mandates. CaseMark researches best practices from university IRBs and quality management standards to ensure complete coverage of training and auditing procedures.

Can I use this for both clinical trials and post-marketing surveillance?

Absolutely. The scope section is tailored to cover both clinical trial and post-marketing contexts based on your needs. CaseMark researches best practices from NCBI and healthcare regulatory sources to ensure the policy applies appropriately to your specific operational environment.

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