Benefits

EDC-CRDMS will provide the Army Medical Research Community with the ability to peform studies in compliance with FDA regulations quickly and efficiently.

• An intuitive graphical user interface (GUI) for data entry
• A secure, validated, FDA-compliant database to store data
• Automated edit checks to improve the quality of data sets
• Automated and manual generation of data queries
• The capability to create standard and custom reports
• The capability to export data for use with other software applications for statistical analysis

The adoption of EDC-CRDMS technology within USAMRMC will also lead to greater command-wide efficiencies in the conduct of clinical trials. InForm™ GTM is expected to improve communication between USAMRMC clinical trial sites and foster greater knowledge sharing and the standardization of processes, procedures, and training across the command. The built-in edit checks are expected to simplify the collection of high quality data sets. InForm™ GTM and Clintrial™ will also help USAMRMC to adopt industry standards such as MedDRA, WHO Drug Dictionary, and CDISC. The two products will provide a complete clinical research data management system and although the primary focus is to support clinical trials, other investigators that conduct non-FDA regulated studies may find the technology equally helpful.

Inform™ GTM

The adoption of InForm™ GTM will enable web-based data input, data queries, and the retrieval of clinical information and records from a central database while providing a diverse set of output/reporting functions. 

Inform™ GTM allows for:

• Creation of Templates for Common Study Designs
• Reuse of Electronic Case Report Forms (eCRFs)
Such as:
• Informed Consent
• Demographics
• Medical History
• Physical Examinations
• Vital Signs
• Labs
• Adverse Events
• Termination
• Coding with the Medical Dictionary for Regulated Activities (MedDRA)
• Coding with the World Health Organization (WHO) Drug Dictionary
• Adoption of Electronic Data Standards i.e. CDISC
• Customizable Reports

EDC-CRDMS allows researchers to capture clinical trial data electronically and rapidly share that information with study team members, monitors, and sponsors. Ultimately, this improves the timeliness of decisions related to the future progress of studies that will hopefully accelerate the approval of new vaccines and drugs.

Clintrial™

In addition to the EDC-CRDMS capabilities of Inform™ GTM the eIT PMO will provide functionality for the capture of data from paper CRF-based studies through the Clintrial™ software.

Clintrial™ allows for:

• Double Data entry from CRFs
• Automated Edit Checks and Data Queries
• Standard and Ad-Hoc reporting functions
• Inegration with the Central Coding Module
• Compliance with CDISC standards and FDA regulations for paper CRF trials.

The inclusion of Clintrial™ will enable the capability to input data from case files (double data entry from CRFs) into a database and allow for similar data checking, data query, retrieval and reporting functions.

More information on these modules can be found on the Oracle/Phase Forward web site . In addition, the eIT PMO has user manuals for all of the products that were purchased for USAMRMC. Please contact the eIT PMO if you would like a copy of these manuals or require additional information.