FORMS & GUIDES
This section serves as a one-stop-shop for the important forms and resources at your disposal when you work with our material. Whether you're a new clinician interested in joining our network or a long-term partner who would like to provide educational material for your patients, you will find all of the resources you should need below.
Joining Our Clinical Network
Clinical Partner Registration Form: a registration form for FMT providers new to our network.
FDA Regulation of FMT: A memo outlining the current status of U.S. regulations of fecal microbiota for transplantation
Ordering Material & Shipping
OpenBiome Order Form: a form for placing new orders for fecal preparations
Storage Controls and Material Specifications: information about shipment sizes as well as instructions for how to store and handle our microbiota preparations
OpenBiome Clinical Primer: a guide for clinicians, by clinicians, on administration of FMT
OpenBiome FMT DE Capsule Clinical Primer: a guide to the use of our FMT capsules
Pre-FMT Patient Guide: a scheduling and cleaning guide for patients preparing for an FMT procedure
Post-FMT Patient Guide: a guide for post-FMT patients about how to minimize the risk of re-infection after their procedure
The OpenBiome Quality & Safety Program
The OpenBiome Quality & Safety Program (Q&SP): the comprehensive guide to our quality metrics and material tracking protocols
Quality & Safety Metrics: this section of the Q&SP focuses specifically on the quality and safety controls that guide our processes from donor selection through material collection and release
Quality & Safety Monitoring and Reporting
Monitoring & Traceability: information about OpenBiome's forms for tracking the safety and efficacy of FMT material and how to complete them
FMT Follow-Up Form: deidentified patient outcome data, to be submitted 8 weeks after FMT procedure for every patient treated
Adverse Event Reporting Checklist: consult this checklist prior to reporting an adverse event to ensure that all relevant information is submitted
FDA MedWatch Form 3500: the form FMT providers should submit to the FDA and OpenBiome in the case of a serious adverse event
Need more? If you don't see a form or resource that you would find helpful, please don't hesitate to email firstname.lastname@example.org and we'd be happy to provide what you're looking for.