For over 30 years, Theradex has played a key role in monitoring early Phase Clinical trials for the NCI. The Clinical Trials Monitoring Services (CTMS) program collects Phase I cancer trial data and audits the NCI-supported cancer center programs participating in these early phase trials and national cooperative group clinical trials. During the five successive award periods of this contract, Theradex has gained significant experience in the treatment of cancer and allied diseases at the premier cancer centers in North America. Through the CTMS, Theradex has also been engaged with the leading clinical investigators involved in early clinical trials during three decades of new anti-cancer therapeutic approaches, from cytotoxic chemotherapy to immunotherapy to targeted therapies requiring genetic-profiling of cancer patients.
In March, 2014 the Experimental Therapeutics Clinical Trials Network (ETCTN) was launched by NCI to consolidate and integrate the conduct of all early phase clinical trials across NCI. All ETCTN protocols are monitored through Theradex's expanding CTMS program.
|Web Reporting - Quick Reference for CTEP Monitors|
IWRS for ETCTN studies
|IWRS Slot Reservations and Cohort Management User Guide|
|ETCTN CTCAE v4.03 to CTCAE v5 CTEP-AERS User Guide|
ETCTN Specimen Tracking
|CTMS Case Report Forms|
|CRF Completion Manual Version 3.13|
|CRF Manual Revisions from Version 3.12 to Version 3.13|
|CRF Manual Revisions from Version 3.10 to Version 3.12|
|Data Transmission Specifications Manual Version 3.12|
|ACES® for Windows Manual Version 4.18|
|ACES® for Windows Manual Version 4.17|
|CTCAE-4.03 (Oct 2009) Toxicity Coding Chart|
|SDC-1 (Jul 2007) Disease Coding Chart|
The "Theradex® Utilities" is a small Microsoft Windows application that brings an assortment of useful clinical data management utilities to the desktop. Version 2.2.1 has replaced version 2.2 and contains:
1. An electronic equivalent to the famous Theradex® "DateWheel". With two calendars on-screen, you can point-and-click to subtract dates or add intervals.
2. Metric converter for height, weight, temperature, and other units.
3. BSA (Body Surface Area) and BMI (Body Mass Index) calculators.
4. Browsable versions of the CTCAE-4.03 and SDC-1 dictionaries, with the CDUS codes.
Version 2.2 is compatible with Microsoft Windows 98/NT/2000/XP, but requires a screen resolution of at least 800x600.
The utility now includes the following dictionaries:
1. CTCAE v4.03 (MedDRAv12.0) (Effective October 1, 2009)
2. CTEP SDC v1.0 (MedDRA v10.0) (Effective July 1, 2007)
If your browser gives you an "open" button, you may click it to install directly from the web. Otherwise, save the setup program to your PC and then run it to install. Newer versions of the Utilities can be installed on top of, and will replace, older versions.
|To Contact us: firstname.lastname@example.org
Tech Support: CTMSsupport@theradex.com