 |
Welcome back. We hope the first edition of the Clinical Research Connection was of value to you; and that each subsequent issue includes information you can use; as well as an opportunity to increase communication and interaction.
Providing a vehicle for our affiliate members to share news, ideas and suggestions, reports on ECOG meetings and programs, and call attention to high-priority trials, are some of the goals for this newsletter. What else would you like to see? What kind of articles would facilitate our joint efforts? Please send Vera Jackson your feedback and suggestions at affiliates@northwestern.edu.
|
Click for larger image
|
NOTIS is a web-based database for comprehensively capturing the data generated by cancer clinical trials. NOTIS currently is used to capture consent, regulatory and patient demographic information on all patients accruing to oncology protocols open at Northwestern or one of its affiliated healthcare providers.
|
The Northwestern Oncology Trial Information System (NOTIS) is a clinical trial management system developed at the Lurie Cancer Center to meet the diverse needs of our Clinical Research Office (CRO). Prior to the development of NOTIS, no comprehensive system existed with administrative, financial, and regulatory tools, a tool to disseminate the most recent IRB-approved consent and protocols across multiple sites and facilities, robust clinical trial data management (Patient Study Calendaring) capabilities, and the ability to report a wide range of data to federal agencies.
Clinical research coordinators can use the database to store all information related to subject entry (demographic data, registration/randomization date, treatment start date, treatment assignment, etc.), as well as using NOTIS to create a master schedule for each study that accurately reflects a trial’s treatment schema. Once the master schedule has been constructed, NOTIS provides the tools for managing the treatment and tracking the progress of subjects enrolled in a given study. It also tracks the regulatory milestones in opening and running clinical trials (scientific review approval, IRB submission and approval, contract negotiations, continuing reviews).
NOTIS, in use since 1998, currently houses patient information on more than 70,000 patients from multiple affiliates, and is used daily by more than 60 individuals working on 700 clinical trials. The system employs a novel method for keeping patient records anonymous while preserving the correlation of a patient’s record to associated experimental data.
NOTIS is also used to track administrative details of the protocols, patient registration, enrollment and demographics, detailed patient response data while on protocol, and follow-up of patients off protocol. Dozens of reports are available from NOTIS to facilitate the monitoring of study progress, including the generation of delinquency rates, accrual overtime, and patient schedules.
What is unique about NOTIS?
- All aspects of NOTIS, including administrative functions, are web-based.
- NOTIS is designed with the management of protocols in mind, allowing our 40 coordinators to track over 400 open protocols simultaneously.
- NOTIS provides the data coordinators with the tools necessary to create an accurate and complete representation of the treatment schedule, and enroll patients on a treatment protocol.
- NOTIS provides administrators, coordinators and managers with tools to easily generate reports that include aggregate, de-identified data-describing protocol, phase, disease site and accrual subtotaled by time interval (month, quarter, year).
- NOTIS provides coordinators with web-based tools for building case report forms (CRF) and matching the CRFs to time points or clinical response points reached during a trial.
- NOTIS provides coordinators with web-based tools for building survey forms and tracking patient responses to surveys, accessible throughout the world.
- NOTIS makes it possible to maintain a paperless protocol system--feeding a web page that makes the most recently IRB-approved protocols and informed consent documents available electronically.
With NOTIS you can:
- Register patients on a protocol at multiple institutions
- Track subject consents
- Track protocols from LOI to closure, including all regulatory requirements and milestones
- Provide a central method for security and de-identification
- Connect patient on protocol information to a sample and sample data
If you would like to view NOTIS, a public site with an indexed search of all currently open trials is available at http://cancertrials.northwestern.edu/search.html. Users of this public interface are NOT able to access any patient-specific information, including current accrual and accrual goals. For questions regarding the use of NOTIS at your site, please contact Drashti Desai at d-desai@northwestern.edu.
|
|
|
