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| Intended Audiences:
Clinical Trialists, Protocol Builders, Data Managers, Research Nurses, Site Monitors, Clinical Research Associates
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| Area of Focus:
Clinical Trials Management |
Primary Workspace:
CTMS |
Product Description:
Cancer Central Clinical Database (C3D) is a clinical trials data management system. C3D collects clinical trial data using standard case report forms (CRFs) based on common data elements (CDEs). C3D utilizes security procedures to protect patient confidentiality and maintain an audit trail as required by FDA regulations. C3D currently supports electronic submission of clinical trials data to the National Cancer Institute’s (NCI) Clinical Data System (CDS) and the Clinical Trials Monitoring Service (CTMS/Theradex). C3D consists of three web-based components: Oracle Clinical, for protocol building; Remote Data Capture, for data entry and management; and Integrated Review / Java Review, for real-time access to clinical data within and across clinical studies to authorized users.
There are two ways to adopt C3D: (1) utilize the hosted solution from NCICB or, (2) install it at your Cancer Center. |
| Current Version Number: 4.5.2 |
Release Date of Current Version:
January 2007 |
Currently caGrid Enabled?
No
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caBIG™ Compatibility Level:
Bronze
Learn more about compatibility levels |
| Tool Maturity Assessment:
Mature Product (Successfully Adopted) |
Installation Level:
Intermediate - technical assistance may be required, download may require supporting infrastructure or software
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Architecture Type:
Web Application - Remote application with data uploads/downloads through web interface, Enterprise System/Infrastructure - Server/Network Dependent |
System Requirements:
For Hosted Environment:
- Pentium III or Pentium 4 CPU
- Microsoft Windows 2000, Service Pack 4, OR Windows XP, Service Pack 1
- Microsoft Internet Explorer version 6, Service Pack 1
- Jinitiator 1.1.8.25 (downloads automatically at launch)
- Adobe Reader version 6.0 or above [required only for data entry]
- OPA PDF Plug-In (downloadable from log-in page) [required only for data entry]
For Onsite Install:
• All requirements for Hosted Environment
• Database:
- Oracle 9i (9.2.0.6)
- Sun SPARC Solaris, HP-UX PA-RISC, OR Windows 2000 or Windows 2003 server
- Compiler Sun ONE Studio 8 or 9 OR HP92453-01 B.11.11.28706.GP HP C
• Middle Tier:
- Forms Server: Oracle 9i Application Server
- Reports Server: Oracle Application Server 10g
- Windows 2000 or Windows 2003 server |
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| End User Support Resources |
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NCICB Applications Support Email: ncicb@pop.nci.nih.gov Telephone: 301-451-4384 Toll-free: 888-478-4423
CTMS Workspace Lead Miguel Buddle [buddle_miguel@bah.com, 206-587-0060]
NCI Facilitator Christo Andonyadis [andonyac@mail.nih.gov]
In addition, the NCICB training team provides excellent support for new and existing users. In special circumstances, NCICB may be able to provide on-site assistance if necessary. NCICB is there to help support you and make this as smooth a transition as possible. |
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| CDE Browser (http://cdebrowser.nci.nih.gov) Cancer Central Clinical Participant Registry (C3PR) Clinical Data System (CDS) Clinical Trials Monitoring Service (CTMS/Theradex) Integrated Review / Java Review, a reporting tool from Integrated Clinical Systems Patient Study Calendar [under construction] caExchange Data Hub [under construction] Cancer Adverse Event Reporting System (caAERS) [under construction] Protocol Lifecycle Tracking [under construction] |
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Demo Files & Exercises
C3D Test Drive
Guest Account Login
To test-drive C3D, please use URL: https://octrials-train.nci.nih.gov/opa45/rdcguest.htm. You will need to download and install two plug-ins: JInitiator and RDC PDF (English); please follow the Downloads link on the login page. Once the plug-ins are successfully installed, please use account ID OPS$GUEST, password GUEST08$, and the database name OCTRN.
Upon login, you will have a chance to exercise all available features of the current end-user component of C3D – Remote Data Capture (RDC) – using a test study CABIG_GUEST
Tips for C3D Client Setup
- You will need privileges to install software on your computer
- You must use MS Internet Explorer v6 or v7.
- Prior to installing plug-ins, you need to have Adobe Reader or a full version of Adobe Acrobat Standard or Professional, versions 6, 7, or 8.
- No custom Toolbars should be installed in your Internet Explorer (i.e., no Google Toolbar, Yahoo! Toolbar, or any others)
- Please contact NCICB Application Support (ncicb@pop.nci.nih.gov) if you encounter any problems installing this additional software.
Documentation & Training
Access the caBIG™ Learning Management System to learn about training programs, register for classes, track your progress, and stay informed about training offerings. We invite you to explore the catalog to see what is available. You will need to create an account before registering for classes.
Application Support: http://ncicb.nci.nih.gov/NCICB/support C3D Support page: http://ncicb.nci.nih.gov/NCICB/support/c3dsupport Training Modules: http://cabigtraining.nci.nih.gov
Tool Download Files
Please contact NCICB Application Support (ncicb@pop.nci.nih.gov) to request a C3D Overview session if you are interested in pursuing C3D adoption.
Developer Institution(s)
C3D DEVELOPERS:
NCICB - C3D Utilities and Extensions
Oracle Corporation - Oracle Clinical and RDC
Integrated Clinical Systems - Integrated Review / Java Review
Adopter Institution(s)
C3D ADOPTERS:
Albert Einstein / Montefiore
- Xin Zheng [xzheng@aecom.yu.edu, 718-430-3429]
Arizona Cancer Center
- Steve Rodney [srodney@azcc.arizona.edu, 520-626-4091]
Arkansas Cancer Research Center
- Troy Walls [tcwalls@uams.edu, 501-686-7875]
NCI Center for Cancer Research
- Elizabeth Ness [nesse@mail.nih.gov, 301-451-2179]
- Deven Shah [shahd@mail.nih.gov, 301-435-5619]
Duke University
- Bob Annechiarico [bob.annechiarico@duke.edu, 919-668-5188]
- Bill Banks [william.banks@duke.edu, 919-681-5417]
- Farid Mohammad [M.Farid@duke.edu, 919-681-4873]
Georgetown / Lombardi
- Jieping Li [lj38@georgetown.edu, 202-687-0115]
- Elsa Lin [yl238@georgetown.edu]
Oregon Health & Sciences University (OHSU) Cancer Institute
- Lara Fournier [fourniel@ohsu.edu, 503-494-8446]
University of California at Irvine / Chao Family Comprehensive Cancer Center
- Andrea Hwang [ychwang@uci.edu, 714-456-2226]
University of Minnesota
- Dr. Kevin Peterson [peter223@umn.edu, 612-624-3116]
- Carol Lange [lange076@umn.edu, 612-624-3125]
University of Nebraska Medical Center
- Simon Sherman [ssherm@unmc.edu, 402-559-4497]
- Marsha Ketcham [mketcham@unmc.edu, 402-559-5286]
- Oleg Shats [oshats@unmc.edu, 402-559-2612]
University of Pennsylvania / Abramson Cancer Center
- Vicki Sallée [vsallee@mail.med.upenn.edu, 215-349-5238]
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