Central IRB/Master Contracts
Overview of the CIRB/MCTA Pilot Initiative
The ALS Association is funding an initiative to pilot the establishment of a central IRB (CIRB) and Master Clinical Trial Agreement (MCTA) process for NEALS research studies. Using NeuroNEXT as a model, the goal of this pilot is to determine whether a streamlined IRB and contracting process for NEALS studies is possible. Sites that have been selected for the pilot and are subsequently selected for studies that plan to use the CIRB will contribute to this exploratory, process improvement exercise.
Site selection for this pilot project occurred in 2014. Sites were chosen using a combination of metrics including (but not limited to): previous site performance in past NEALS studies, speed of contracting, member participation on committees, leadership of NEALS studies, NeuroNEXT membership, and status of NEALS membership dues. Initially, 15 sites were selected and 14 have confirmed their willingness to use a CIRB and master contract process. Subsequently, 20 additional sites were added [see list of participating sites below].
Currently there are two studies utilizing the CIRB/MCTA program – the Cross-Sectional ALS Biofluid Biomarker (CABB) Study and the Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for Treatment of Amyotrophic Lateral Sclerosis (ALS) (CENTAUR) Study.
In the future there may be additional opportunities to participate in the CIRB program and as a NEALS membership site in other new initiatives.
List of Participating Sites:
- ALS Center at the Swedish Neuroscience Institute
- Barrow Neurological Institute
- Beth Israel Deaconess Medical Center
- California Pacific Medical Center
- Drexel University
- Duke University Medical Center
- Emory University
- Henry Ford Hospital
- Johns Hopkins University
- Massachusetts General Hospital
- Medical University of South Carolina
- Minneapolis Medical Research Foundation
- Mount Sinai Beth Israel
- Neurology Associates
- Ochsner Neuroscience Institute
- Ohio State University
- Oregon Health & Science University
- Penn State University School of Medicine
- Temple University
- Texas Neurology, P.A.
- UMASS Memorial
- University of California, Irvine
- University of Florida, Gainesville
- University of Iowa
- University of Kentucky
- University of Massachusetts
- University of Michigan
- University of Miami
- University of Pennsylvania
- University of South Florida
- University of Texas Health Science Center, San Antonio
- Vanderbilt University Medical Center
- Wake Forest University Health Sciences
- Washington University in St. Louis
Central IRB: Partners Human Research Committee/IRB (Massachusetts General Hospital and Brigham and Women’s Hospital)
Resources for Pilot Sites:
- Template ICF
- Reliance Agreement
- SOP NEALS CIRB 100 – COI and FD Requirements
- SOP NEALS CIRB 101 – CIRB Reliance Process
- SOP NEALS CIRB 102 – CIRB Reporting
NEALS Central IRB (cIRB) Model Webinar
September 12, 2016
This webinar was presented by the NEALS Central IRB. Covered in this webinar were general comments on central IRBs, a brief overview of the NEALS cIRB model, and a discussion on the NEALS Reliance Agreement.
NEALS cIRB and CENTAUR Study Webinar
November 1, 2016
This webinar was presented by the NEALS Central IRB and the CENTAUR Study Principal Investigator. Covered in this webinar were general NEALS cIRB processes, an overview of the NEALS CENTAUR Study, and a discussion on potential protocol issues.
This initiative is made possible by the generous support of ALSA.