Adverse Events and Product Complaint Reporting

Access training and resources to learn how to report recipient adverse events and product complaints through our Event Reporting System, FormsNet3^SM.

We require transplant centers to report all qualifying recipient adverse events and/or product complaint events on all recipients of cellular product that we facilitate. FormsNet3 is a system used by the Event Reporting System (ERS) to capture information about recipient adverse events and product complaints.

FormsNet3 Qualifying Event Forms

Recipient Adverse Event Form (Form 3001) - Used to report serious adverse events and reactions associated with cellular product infusion. In addition, report any recipient exposure and/or seroconversion to any FDA-listed relevant communicable diseases determined to be caused by or potentially caused by the product. Reporting is also required for any recipient bacteremia related to a contaminated product.
Recipient Adverse Event Follow-up Form (Form 3003) - Used to report new information on a previously reported adverse event.
Product Complaint Form (Form 3010) - Product complaints must be reported for all cellular products that we facilitate. Qualifying product complaints include issues related to product integrity with potential impact to the safety, quality, identity, purity, or potency.
Genetic Mutation Report Form (Form 3004) - Used to report any genetic mutations found in their recipients that may be donor-derived back to the NMDP. This form is available on FormsNet3.

All qualifying adverse events and product complaints must be reported within 3 business days of the center becoming aware of the incident.

Training: Recipient Adverse Event and Product Complaint Reporting

Learn about the terminology used for adverse event and product complaint reports, the events considered reportable, the elements need to file a report, and the time frame for reporting events.

Access the Training

Please log in to the NMDP Learning Center.

Returning users: Log on to the Learning Center
New users: Create an account in the Learning Center using the link on page 1 of the User Guide for Network Members (PDF).
NMDP Employees: Access the Learning Center.

At least one person from each U.S. transplant center who is involved in the adverse event or product complaint reporting must be trained and report via the ERS. It is strongly recommended that personnel from non-U.S. transplant centers are trained and report via the ERS.

Training: Post-Donation Genetic Mutation Reporting

Learn about why this reporting process for genetic mutations is being implemented; an overview of the reporting process; and how to report on genetic mutations via the intake form.

Access Training

Resources

Event Reporting Form Samples

Form 3001: Recipient Adverse Event (PDF)
Form 3010: Product Complaint (PDF)

Form Instructions

Quick Reference Guides

Adverse Event Quick Reference Guide (PDF)
Product Complaint Quick Reference Guide (PDF)

Background on Event Reporting System: A Simplified Process

The Event Reporting System provides a single mechanism for transplant centers to report adverse events and product complaints to the NMDP, thus simplifying the process for centers and saving centers time and resources. Investigations of adverse events and product complaints can also be initiated more quickly by Transplant Medical Services and Quality Systems because the electronic forms systematically collect all pertinent information upfront. In addition, the Event Reporting System enhances the NMDP's ability to comply with all reporting obligations we have to regulatory and funding agencies such as the FDA and HRSA.

Background on Genetic Mutation Reporting Process

The NMDP has implemented a protocol consent change and standardized way to report genetic mutations detected in donor-derived cells. By outlining this reporting process, the NMDP can respond to the results of next-generation sequencing technology for disease surveillance, notify donors of the process, and have them opt in at workup if they want to be notified about genetic changes of unknown significance.

The NMDP will notify donors, regardless of opt in status, of any/all medically actionable genetic changes with known significance. Genetic mutations may be identified during post-donation marrow and/or peripheral blood genetic testing. In such cases, the transplant center is expected to report any genetic mutations found in their recipients that may be donor-derived back to the NMDP. Findings are to be submitted through FormsNet via the Genetic Mutation Report Form (Form 3004). This notification provides NMDP with information that supports communication back to the donor with information and support.

Questions?

For FormsNet3 access, please contact Angela Hauck, Supervisor, Center Support Services, at 763-406-8451 or ahauck@nmdp.org.
For recipient adverse event questions, please contact Transplant Medical Services at TMS@nmdp.org.
For product complaint questions, please contact Quality Systems, Quality Assurance Team at quality@nmdp.org.
For questions on the Genetic Mutation Reporting process, please contact the Transplant Medical Services team at tms@nmdp.org.