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 is flexible enough to support different workflow scenarios based on your needs - you determine the specifics. CPDM includes an array of features which facilitates page, record and query tracking; review and cleanup cycles; coding of adverse events and medications; complete audit trail maintenance; user and data set security and more. By managing all of your data processing procedures with one system, you are ensured a smooth progression from entry of the first casebook to a clean and locked database. CPDM is a SAS-based application that enables you to utilize the power of SAS and FSP 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. As your study progresses through the phases of data processing, you will be able to simultaneously enter, review, clean, code, track, access and print your data with ease.

CRF Tracking and Audit Trail Maintenance

CPDM offers superior capabilities for accessing information through all processing phases of your project. Case report forms (CRFs) may be tracked individually, at the visit level or at the casebook level; bar codes may be used to identify your pages. All user functions are logged, including all data entry/initialization actions, changes to verified data, query resolution and so on. You have a variety of reports at your fingertips to summarize the status and history of each page/record. CPDM supports batch tracking, and key information can be embedded in the bar code.

Database Structure and Screen 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 libraries of standard data bases/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 does not 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.

Coding of Adverse Events and Medications

One of the most challenging aspects of coding is to ensure consistency without sacrificing flexibility. CPDM is seamlessly integrated with ClinPlus Coding®. ClinPlus Coding has been designed to work with virtually any adverse event, drug or any other type of dictionary. An algorithm incorporating advanced matching techniques like word sorting, special character and trivial word removal and word swapping will ensure a high hit rate while auto coding. A powerful dictionary search tool aids in the manual coding process. Using the perpetuate feature, each time an item is manually coded, all other identical items are also coded. Then, the next time you auto code, the system will use your previously coded items within the current study and across other selected studies to code all new like items. This will ensure consistency and will increase your hit rate as the system "learns". Naturally, all coding actions are recorded in an audit trail.

Study Management

Throughout each study, you will want to evaluate its 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.