The request won’t wait.
Know the eligibility rules before a patient asks, so a delay on your end doesn’t cost them time.
FREE accredited CME course
Right to Try: Clinical Protocol & Regulatory Reporting
A FREE 3-hour online course on the federal Right to Try Act for clinical investigators, treating physicians and sponsors. It covers which investigational drugs and patients qualify, what the treating physician must disclose and document, what safety data goes to the manufacturer, and what the manufacturer files with FDA each year.
- Duration
- 3 hours
- Modules
- 4
- Format
- Online, self-paced
- Credit
- [3.0 AMA PRA Category 1 Credits™]
- Assessment
- [Post-test, 80% to pass]
- Cost
- FREE
Why every request needs a clear process
Dr Elliot Lander introduces the course: why a Right to Try request carries real responsibility for the treating physician, and what the three hours cover, from eligibility to FDA reporting.
When a patient asks, you’ll need to be ready.
Right to Try requests usually come from patients who are out of options and short on time. There’s no IRB or FDA review to catch a missed step, so the decisions and the paperwork rest with you.
Built from the statute and 21 CFR 300.200, not from summaries.
No FDA review. No IRB. The record is yours.
Right to Try lets an investigational drug reach a patient without FDA authorization or IRB review. What replaces that oversight is a chain of four parties, each with a legal obligation to the next. The course takes you through every link.
Patient
Has a life-threatening condition, has exhausted approved options, and cannot join a clinical trial.
Written informed consent
Treating physician
Certifies eligibility, presents every approved alternative, and obtains consent.
Doses, chain of custody, serious adverse events
Manufacturer
Supplies the product at direct cost and tracks every use of it.
Annual summary
FDA
Receives the annual summary of doses, patients, uses and serious adverse events.
What the course covers
Four modules, in the order a Right to Try request unfolds. Every requirement is tied to its source in the statute or the Code of Federal Regulations.
1
Regulatory Framework, Statutory Thresholds & Legal Scope
Does this product, and this patient, qualify?
- The statutory authority under Section 561B of the FD&C Act, and how it relates to state laws
- The eligible investigational drug: Phase 1 completed, active IND, not approved for any use
- The eligible patient: a life-threatening condition, and certified inability to join a clinical trial
- The approved treatment options standard, and how to document it
2
Physician Obligations to the Patient: Presenting Alternatives & Informed Consent
What must the patient understand before signing?
- Every standard-of-care FDA-approved drug, biologic, surgery and therapy for the indication
- The efficacy, toxicity and adverse reaction profile of each approved option
- Written consent: investigational status, risks up to and including death, direct-cost recovery and insurance, and the right to withdraw
3
Physician-to-Manufacturer Data Transmission & Safety Reporting
What goes to the manufacturer, and how fast?
- Lot, serial, expiry and storage records, including cryopreservation for cellular therapies
- Dose accounting for every administration
- Serious adverse event definitions and notification timelines
- The safety package: narrative, concomitant medications, timeline and causality assessment
4
Manufacturer Annual Compliance & Form FDA 5023 Filing (21 CFR 300.200)
What is filed with FDA, where, and when?
- The March 31 deadline, covering the full prior calendar year
- Submission routes: the CDER NextGen Portal, or email for CBER-regulated biologics and cellular therapies
- The five required elements: drug and IND number, doses supplied, patients treated, uses, and known serious adverse events with outcomes
Four details that decide whether a case complies.
“Exhausted”
The statute requires that approved treatment options be exhausted, not merely discussed. The course shows how to document it.
The same product
Only the manufacturer’s investigational product under its IND qualifies. A comparable product does not.
Direct cost only
The product may be charged at direct cost, with no markup by the manufacturer, the physician or the clinic.
One patient, many doses
Each patient is counted once on the FDA summary. Every dose supplied is counted.
How the course works
Written for everyone in the chain.
Questions
- Do I need a regulatory background?
- No. The course starts from the statute and builds step by step.
- Is it relevant outside the United States?
- Right to Try is U.S. federal law, so the course applies to patients treated in the United States.
Be ready before the first request arrives.
Give every request the same documented process, and know the file is complete before the first dose.
Accreditation. [Pinnacle Conference, LLC joint accreditation statement and the credit designation statement for this activity.]