CISR provides initial user training and annual retraining courses to ensure understanding about data collection tools including patient statuses, case report forms and calendars. HICCC Investigators continue to collaborate with outside institutions by opening multicenter trials. We also train study teams at outside institutions with remote presentation software, which allows them to enter clinical trial data directly into our CTMS. This saves time with data entry and allows investigators to publish their results more efficiently than other data collection methods such as paper case report form. Outside users will need to apply for and be given a UNI for access to the CTMS. A form to request IDs is available here.
Data Collection Tools
Case report forms and calendars for institutional trials are custom tailored to ensure compliant data capture and minimize protocol violations. This review process involves meeting with the study team to determine the needs of the protocol. To complete the process and activate the forms, the study team must review the data collection tools and provide their authorization to activate the forms.
Quality Assurance Tools
CISR provides workflows to allow investigators to monitor data utilizing a CTMS quality dashboard. . In addition, quality assurance staff at CUMC can query data from outside institutions in real time, and affiliate users can answer queries from the affiliate site. All data are secure and auditable. These initiatives empower HICCC investigators to increase the capture area of their investigator-initiated clinical trials while maintaining data integrity.
The CISR offers this service when study teams have data housed outside of the CTMS that need to be integrated with data that will be housed in the CTMS. The CISR meets with the study team to develop a plan that ensures the correct data mapping to CTMS case report forms and calendars as well as quality control measures to maintain data integrity.
The CISR also offers services and the benefits of the CTMS to investigators that conduct research with a large amount of participants. We work with the study team to determine the appropriate case report forms and required variables. The CISR provides tools to study teams to facilitate quality control measures for clean data collection. This facilitates the preparation of the data for statistical analysis. For example, the CTMS can automatically create user queries when data is not entered in a recognized format, which decreases the amount of time necessary for data cleaning before analysis and publication.
The CISR provides specialized programming solutions. For example, the CISR designed and deployed a solution for the small animal imaging shared resource for one of their imaging instruments. Users log into the workstation attached to the instrument using their university single sign-on, and all files created during their session are uploaded to a web application, also accessible through single sign-on, and then deleted from the local workstation.
Hourly Service Rate: Includes form, calendar, report generation, and programming.
Cancer Center Members: $105
Non-Cancer Center Members: $125
CTMS Maintenance, Annual Fee per Protocol; Includes security, backups, Velos training.
Cancer Center Members: $275
Non-Cancer Center Members: $275
CTMS Maintenance, Affiliate Fee per Site per Year for Multicenter Trials
Cancer Center Members: $50
Non-Cancer Center Members: $50