ClinPlus® Data Management (CPDM) is a comprehensive 21 CFR Part 11 compliant SAS® based system for managing clinical projects. From database design to end of study, CPDM provides you with the means to achieve efficient data processing with a minimum investment in installation and setup time. CPDM supports paper-based studies, site based entry or a combination of both within the same study. CPDM includes an array of features which facilitates page, record, and query tracking; review and cleanup cycles; complete audit trail maintenance; role-based security, and more. By managing all of your clinical data management with one system, you are ensured a smooth progression from entry of the first casebook to a clean and locked database. 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.

EDC, Paper, Images As the industry slowly moves toward site-based entry, companies are finding it necessary to support multiple modes of clinical data management, sometimes within the same study. CPDM supports site-based entry with features like role-based menus, electronic signatures and site based security. Using software from Citrix®, CPDM is web-enabled using any browser, minimizing the need to qualify hardware and software at the site. Data is entered directly into the central database so intermediate data at the remote site never exists. And, if some sites are unable or unwilling to participate in site-based entry then traditional paper based management can be used for the same study. This eliminates the need for two separate CDM systems. CPDM can also be integrated with image management software such as TeleForms® to support fax based and side-by-side image entry. Regardless of your mode of entry, CPDM has a solution.

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 items that can be incorporated. Structures and screens can be changed mid-study in minutes with minimum disruption to data entry. In cases where protocols are very similar, the complete study can be modeled and adapted quickly to additional protocols. CPDM supports creating and maintaining 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, values can be initialized or carried over from screen to screen. Time saving extras like these strengthen overall performance of your data processing team.

Data Review and Correction Cycle Data cleanup doesn't have to slow down a project's momentum. CPDM supports both manual and computerized review before, during, or after data entry. It enables you to maintain a library of standard questions which speeds Data Resolution Form (DRF) preparation and promotes consistency, to customize and generate DRFs with a word processor for printing, faxing or email, and 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 your pages. CPDM supports batch tracking, and key information can be embedded in the bar code.

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, SAS format changes and so on. You have a variety of reports at your fingertips to summarize the status and history of each page/record.

Study Management Throughout each study, you'll want to evaluate progress, the number of pages at each stage of the process, pages and queries that are past due, personnel performance and so on. With a click of the mouse you can quickly obtain such summary information. 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. CPDM's importing utility allows you to import data from other sources such as labs, fax, OCR, email, etc. and make them system compatible in a single step.

Perfect your data processing operation Use CPDM for cohesive, efficient data management. All of your data processing needs are successfully met, and the data is always accessible as SAS® data sets from the beginning of entry to the locked database. CPDM is your complete solution for data management.