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Design Features of a Clinical Information System Bernadette Johnson Pharmaceutical Product Development, Inc. Concurrently, SAS programs are written and run to validate the master database. These programs include single field checks, crossfield comparisons, and value checks across datasets. The programs are run periodically and inconsistencies are researched and corrected. Abstract At Pharmaceutical Product Development (PPD), we needed a flexible system to facilitate data management and biostatistics activities. The task was to develop a common interface to access multiple and fluctuating numbers of clients and studies per client. PPD Clinical Information System (PPDCIS) is developing as a data driven application that uses a central database to: control access to data across clients and studies and adjust immediately to an addition or deletion of a client or study. After the databases are complete and validated, the biostatistics department creates statistical databases for analyses. General Application Features This paper will give a general overview of the application features of PPDCIS and describe the design and advantages of the application's central database, PPD Project Access and Security System (PPD-PASS). PPDCIS is being developed with Release 6.06 of SAS / AFR software, SAS /FSpR software, and Screen Control Language(SCL) under the VMS R operating system on a Digital VAXR 4000 machine. Background - Flow of information The basic application areas are: The Data Management and Biostatistics Division receives case report forms (CRF) for each patient enrolled in the clinical trial. These forms contain information such as demographic information, medical history, physical exam reports, therapy logs, and adverse event documentation. This information will be entered into a project database, validated, and presented to the biostatisticians for analysis. CRF TRACKING a database and reporting SYSTEM system that logs tlie activities and [ocation of each CRF page PROJECT DATA facility to access Rroject MANAGEMENT specific CRF tracking ifrformation, data enfry system and utilities, master databases, and project management tools BIOSTATISTICS on-line review system for biostatistics databases including, gen.er~ting reports, submlttmg pr!Jg~ams and other utlhtles UTILITIES general application utilitie~ such as access to the PPu-PASS database. Project setup includes creating a database to store the CRF information. SAS/FSP software is used to create customized screens used for data entry, review and modification. As CRFs are received, each page is log~ed into the CRF tracking database. Each form IS reviewed for discrepancies and readied for data entry. Dual data entry is performed on small batches of 10 - 15 patients. After each batch is completed, the data are moved to a dated subdirectory in a post entry directory. New entry databases are created and data entry resumes. The post-entry databases are compared to report data entry discrepancies. The databases are corrected and uploaded to the master database. 869 PPD-PASS - the Application's Central Dataset The PPD Project Access and Security (PPDPASS) database interactively defines the scope of the application. PPDCIS reads this dataset to determine the list of clients and studies, the location of the data, autocall macros, and format catalog. Some advantages to the design philosophy are: IMMEDIATE any changes in this APPLICATION dataset, such as a client UPDATES being added or deleted, is automatically' reflected in the client ana project menus APPLICATION all system dependent IS MORE references, like directory SYSTEM paths, are external to the INDEPENDENT application code. This reduces application maintenance and makes the application portable to otfier operatmg systems RESPONSIVE when project data are TO SYSTEM moved to another disk, a CHANGES new macro directory is needed, or a format catalog moves to another directory, one dataset modification updates the application REDUCES the application code uses REDUNDANT information such as client CODE and study names and titles to customized menus and screens with study specific information. This reduces the number of study specific programs. PPD-PASS Solutions Following are a few situations where using the central database philosophy has shown positive results. Situation: A new client, Company D, has chosen PPD for biostatistics and data management work. The project setup work is complete. How do we update the clinical information system? Solution: Currently, there are three companies, with multiple studies, in the system. The client/study selection menu is shown in Figure 2. To add company D: 1. Add Company D information to PPD-PASS dataset (Figure 3). 2. Access the client/study selection (Figure 4). Notice that the menus have been updated to reflect the changes. Situation: PPD-PASS Dataset The disk that holds the data from Company B is fulL How long will the information system be down after the data are moved? A partial view of the PPD-PASS dataset is shown in Figure 1. The dataset contains: Solution: Five minutes or less. Simply update the PPDPASS dataset with the new data location and the system will access Company B data from the new location. Client a client nickname used to group all of a client's studies Client Description the full name of the client Drug full name of the drug Title 1 - Title3 long description of the study Study directory the base directory of the path study information Autocall macro the paths to the macro directories programs used by the study Format Catalog the location of the study specific format catalog. Situation: How can the information system have screens that look customized for each study without creating separate screens? Solution: Pass parameters into menu and screen templates. Example 1: Client Data Access Menu Figure 5 shows the basic client data access menu. The title infcrmation "Company B/STUDY B2" is passed in as a Screen 870 Control Language entry parameter. The client and study values are from the PPD-PASS dataset. When this screen is accessed for another client or study, the appropriate title is displayed. SAS/AF and SAS/FSP are registered trademarks of SAS Institute Inc. in the USA and other countries. R indicates USA registration. Example 2: Data Management Screen Menu VAX and VMS are registered trademarks of Digital Equipment Corporation. The data entry menu and screen illustrated in figure 6 are the same menu and screen used for data modification and review. The first title on the menu, "STUDY B2", comes from PPDPASS. The second title is the result of the user requesting the first data entry session. Also, these user selections determine which database to access, data entry or data management, and whether the database is opened in edit or browse mode. Questions and/or comments may be directed to: Bernadette Johnson Pharmaceutical Product Development, Inc. 1905 Meredith Drive, Suite 200 Durham, NC 27713 Phone: (919) 544-6269 FAX: (919) 544-1474. Conclusion A central database, like PPD-PASS, has made PPDCIS a flexible and dynamic system that responds easily to change. System maintenance time has been reduced by storing all key project information in one dataset. Programming time is minimized by passing parameters into common program templates to create customized menus. 871 END(rF3) Backward(KP4) ForwardlKP5) Search... Whet·e Oup/Oel ... CI ient: COMPANYB Client Desc~iption: Company B Drug Name: Honder Drug II study Ntanber: STUDY 81 Title: The D~uq to Out Sell all Dcugs study Directory Path: COMPANYB$DISK:[OOOOOO] utocall tlacro Directories: COlfPANYB$Hl\CS_Bl COIfPAlr.lB$MACS PPD$liACS_STIIT PPD$HllCS_DH SASAmos Fo~at catalog Directory: COHPANYB$DISK: [COHPAllYB_Bl. FORMIIT. LIBRl\RYJ PPD Project Access & Security Dataset. Figure 1: lEll! [!'Jj[5I1 SAS: AF rrotocol selection Access Protocol Select Again 1l!J. I:i!JlliJvelopment, Inc. QUIT CI ient Oeser iption: Company B ~rotocol Number: STUDY 01 • Mease select a Client Goback company 11 L,itluIW_: company C !ll.li1 Goback STlfl)V Hl STUDY B2 TUDY B3 Place cur:sor on your Figure 2: The Client/Study Selection Menu. 872 ENO(PF3) lIackward(KP4) Forwal'd(KPS) Search... Where Dttp/Oel ... cl lent: COHPANYD Client DescrilJtion: Company D S-S-C-A Study Uumber: STUDY Dl Drug MaIlle: Super strenqth CULe-All Title: Directory Path: .~cro COlWANYD$DISK:[OOOOOO] Directories: COHPAllYD$KACS_DI COlfPlINYD$HACS PPD$IIACS_STAT PPD$IIACS_DM SAS1UJTOS FOL~t Catalog Directory: COHPAUYD$DISK: [COltPANYD_Dl. FORHAT • LIBRARY] Figure 3: lEI Adding New Information to PPD-PASS Dataset. SAS: AF ~Eillvelopmentl Inc. Protocol Selection Access Protocol Select Again l!!illrill 10. QUIT Client Description: Company D Protocol M\Unbar: STUDY Dl please select a Client 11\: Goback _ _ \1 Company l\ company B Company C company D Coback STUDY Dl Place cursor on your Figure 4: Update Client/Study Selection Menu. --------~ 873 .---~ Place cursor on your selection and press the enter key. Figure 5: 1lJ1 Client Data Access Menu. !!'.i11"1 SAS: AF Command ===> STUDY Bl lteuu for Data Entry ScreQus-EllTRY *1 1. Inclusion/Exclusion criteria 2. Uedical History 3. Concurrent Diseases 4. Laboratory Data 5. Adverse Events 6. Patient summary Information END(PFJ) Backward(KP4) Forwat'd(KPS) Seat'ch... Where Oup/DeL. BASELIN Data set Investigator 09 Date drug therapy stal:ted: 022391 010592 Date drug thera})'l stopped: Date of Birth 102461 (mmddyy) Visit 00 Patient 392 Sex Race F (F,U) (C.A.D,H,M~O) If Race = '0', Patient Type (0,1,2) Figure 6: (... ddyy) (nunddyy, u) then: Height l..eight (inches) (potmds) Data Management Menu and Screen.