The Surgical Idiopathic Intracranial Hypertension Trial (SiihTT) represents the next randomized study for the Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC). It utilizes the shared experience of the Study Director, Study Steering Committee, Clinical Sites, three Reading Centers, Data Coordinating and Biostatistical Center (DCBC) and NORDIC Headquarters (now EnrC) in the IIHTT and LIIHT. We have created an efficient organization that provides guidance and management of Neuro-Ophthalmology multi-site research that would not otherwise be accomplished. The EnrC will oversee the selection and certification of 41 Clinic Sites that have agreed to participate in the SiihTT. EnrC specific duties include 1) training Site Investigators and Coordinators on trial procedures and scales, 2) arranging educational and training meetings, 3) performing on-site and remote monitoring of Sites, 4) contracting with and paying Sites and study committee members, 5) devising strategies to improve subject compliance and retention, and 6) maintain a web-based information and communication system. The EnrC will focus on subject recruitment and retention to ensure the SiihTT meets the goal of follow up and complete data collection. The NORDICclinicaltrials.com website will used, as in prior studies, for Site personnel training, subject information, collection of quality of life data, and study finance management. The EnrC, under the leadership of Mark Kupersmith, M.D., has well-established procedures and personnel to accomplish these aims.

Agency
National Institute of Health (NIH)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10EY025990-01A1
Application #
9209033
Study Section
Special Emphasis Panel (ZEY1)
Program Officer
Everett, Donald F
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Icahn School of Medicine at Mount Sinai
Department
Type
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029