Resources

Essential templates and checklists support clinicians in managing treatment access requests efficiently and accurately. These resources provide structured guidance for each step of the expanded access process, helping to streamline communication and documentation.

Expanded access overview and process checklist
Sponsor request email and medical necessity letter templates
Prior treatment summary and patient record checklists
FDA Form 3926 and IRB submission preparation checklists
Monitoring plan, adverse event reporting, and follow-up templates

Key Steps for Expanded Access Requests

Clinicians play a vital role in navigating expanded access pathways. Follow these steps to evaluate and request investigational treatments for eligible patients.

Step-by-Step Process Overview

1. Confirm the patient has a serious or life-threatening condition without satisfactory alternatives. 2. Assess clinical trial availability and suitability. 3. Identify the investigational product, sponsor, and contact details. 4. Review risks, benefits, monitoring, and logistics. 5. Reach out to the sponsor to request access and confirm supply. 6. Complete regulatory, IRB, consent, and documentation requirements. 7. Monitor patient progress and report safety events as required.

Supporting Clinicians with Practical Tools

Treatment Access Alliance offers checklists and templates to streamline the process, helping providers organize requests and meet regulatory standards efficiently.

Educational tools designed to support clinical decision-making

Provider Resources for Treatment Access Requests

These resources serve as educational guides to assist clinicians in organizing and managing treatment access requests. They do not replace clinical judgment, institutional policies, or regulatory requirements.