This comprehensive SAS-based system is ideal for CRF tracking, data entry, analysis and review medical coding and trial reporting. The system can be extended to support Electronic Data Capture (EDC) with the use of Citrix. The system also requires SAS Base, SAS AF and SAS Share software to operate.

DZS is a licensed reseller of SAS and can often provide discounted pricing.

EXECUTIVE OVERVIEW

Highlights of ClinPlus Data Management 

ClinPlus Data Management (CPDM) is a comprehensive, 21 CFR Part 11 compliant, SAS®-based system specifically designed for managing clinical trial data and projects. It allows users to easily navigate the ever-changing data collection, analysis, research, and evaluation requirements of today's clinical trials.

From database design through end-of-study, CPDM provides the tools to achieve efficient data processing and high quality data with a minimum investment in software installation and setup. The software includes an array of features and functions that facilitate page, record, and query tracking; review and cleanup cycles; complete audit trail maintenance; and role-based security.

CPDM can support paper-based studies, site-based entry, or any combination of the two within the same study. By managing all of your clinical data in one system, you are ensured a smooth progression from entry of the first casebook to a clean and secure database lock.

CPDM enables you to utilize the power of Base SAS to develop unique databases and screens for each study, even if you are not a SAS programmer. Your data is entered into SAS data sets so that it is instantly accessible for analysis.

The current ClinPlus Data Management EDC Process provides the following functionality:

• Site Based Access - Allows administrators to restrict what information sites and investigators can view and edit within each study
• Role-Based Menus - Three key roles can be defined for users (SITE ENTRY, MONITOR and INVESTIGATOR) that tailor the system menu to each user's role
• System Security - Allows the administrator to restrict the access a user has to the different tasks and studies
• Data Structures with Role-Based Variables - Add variables to data structures to capture role based information such as monitoring status and investigator signatures
• Screen Design with Role-Based Fields - Allows administrators to control field access based on user's role
• Investigator Signatures - Allows an Investigator to attest to validity of data by applying an electronic signature
• Information - Allows access to system reports, URL links, etc

Study Design

CPDM is flexible enough to build complex data entry systems as well as simple ones. Range checks for individual variables, intricate cursor movement, and pop-up selection lists are among the many features that can be utilized when setting up studies. Structures and screens can be modified in minutes, mid-study, with only a minimum disruption to the data entry process. In cases where protocols are similar, complete studies can be cloned and adapted quickly to additional protocols. CPDM also supports the creation and maintenance of a library of standard databases and screen designs.

Data Entry and Verification

With CPDM, you can perform single or double key entry. Verification for double key entry is done concurrently with second key; verification status is maintained at the variable level. Many CPDM features enhance data entry operations in different ways: for example, screens can be presented in any order, second key verification may be skipped for specified fields, and values can be initialized or carried over from screen to screen. These time-saving extras can significantly strengthen the overall performance of your data processing team.

Data Review and Correction Cycle

Data cleanup does not have to impact a project's momentum, as CPDM supports both manual and computerized review before, during, or after data entry. You can maintain a library of standard questions to speed Data Resolution Form (DRF) preparation and to promote consistency. Users can customize and generate DRFs for printing, faxing, or email, as well as to track each DRF and question. When DRFs are returned, data processing personnel scan or type in a pre-assigned ‘page key,' which immediately brings up the record for correction, saves the amended record, updates audit trail information, automatically changes the record status, and, if all the questions for that page are resolved, updates the page status. Thus, each correction to the database is made in a single action with a complete audit trail.

CRF Tracking

CPDM offers superior capabilities for accessing information through all processing phases of your project. CRFs may be tracked individually, at the visit level, or at the casebook level; bar codes may be used to identify pages. CPDM supports batch tracking and provides the ability to have key information embedded in bar codes.

Audit Trail Maintenance

All user functions are logged, including all data entry/initialization actions, changes to verified data, query resolution, security settings, data structure changes, and SAS format changes. A variety of reports are at your fingertips that summarize the status and history of each page/record, allowing you to meet all audit trail requirements.

Study Management

Throughout each study, you'll want to evaluate progress, including the number of pages at each stage of the process, pages and queries that are past due, and personnel performance. With a click of the mouse, this summary information can be easily and quickly retrieved. You can run pre-defined data integrity checks, adjust security levels and passwords, update data correction codes, and create a wide variety of tracking and performance reports and customizable data listings. In a single step, CPDM's import utility allows you to import data from other sources, such as labs, fax, OCR, and email, and make them system-compatible. Perfect your data processing operation - With CPDM's efficient data management capabilities, all of your data processing needs are successfully met. The data is always accessible as SAS data sets from the beginning of entry to database lock. CPDM is quite simply your complete solution for data management.