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1 272 Phannaceutlcals ndustry Applications Edit-checking: A SAS Based System for Logically Editing Patient Data Records Maria K Wills, Fidia Phannaceutical Corporation ntroduction AtFidiaPhannaceutical Corporation, the department of Clinical Data Management is charged with the collectioo and processing of all clinical study data. The duties of this small group range from case repon form design to assisting statisticians in the analysis of clinical data. Of all their duties, the most imponant is to ensure the quality and completeness of the data being analyzed. The system described in this paper is one of many tools made available to the deparunent of Clinical Data Management to aid them in dlis most imponant task. The Data Collection Process Wben data from clinical trials arrives at the depanment of Clinical Data Management, it arrives most often on a Case Report Fonn (CRF). The CRF is logged according to study, investigator, patient, visit and date and is then forwarded to the Clinical Data Manager who enters the data into the study database. When a significant amount of data is collected and reviewed for transcription errors, the edit-checking cycle begins and continues until the study database is fmalized. A simplifled view of the data collection and -;diting process is given in Figure 1. The System The edit checking system was designed to provide the Clinical Data Manager with a structured environment in which to construct complex logic statements, apply the statements to the study data and produce repoj1s to aid in error resolution. The system consists of three main components: capture and maintenance of logic statements; application of the logic statements to study data; and error repon generation. capture and Maintenance of Logic Statements The logic statements entered by the Clinical Data Manager are the tests that must be passed by the data elements in order for them to be considered clean and acceptable. These statements can be simple range checks on a single variable or complex statements involving several variables. n either -- ~ - ~ -- - n 1 Data Proceo DC J _ L~ ~ - Figure _ _... _ -.. ) _... ' ) =-- case, the statements are entered by the user into a flat VMS me which can be constructed from within the edit checking system or outside the system using the V ~ VMS~ editor and subsequently included. A help facility in the form of a CBT is provided to aid the user in properly constructing the logic statements. The final logic statements are passed through a syntax checking routine which looks for such errors as unbalanced parentheses and quotes, incorrect variable names, and invalid operators. When the statements have been checked successfully, the date of completion is logged. This date is used as a safeguard against a modified but unchecked set of edits being used against study data. Finalized sets of logic statements can be modified, duplicated and combined in order to create new sets. Application of Codes to Data The second major component of the edit checking system is the application of a set of logic statements to the data. n this step the user selects the module of edits to be used and the dataset(s) against which they are to be applied.

2 Pharmaceuticals ndustry Applications 273 At this point in the processing, a SAS job stream is generated and submitted to a VMS batch queue. The output from this job stream is the results listing containing all of the data elements which have been flagged as errors. This results listing is produced both in hard copy for review by the Clinical Data Manager as well as a VMS flle for post-processing by the edit-checking system. An example of a results listing is given in the attached Figure 2. During the process of applying the logic s~ents to the data, a record is sent to an audit trail dalaset for each error detected. The audit trail record contains patient, visit, variable name and variable value for each enor detected and the date of error detection. n addition to these flelds, there is an error flag freld which is used to indicate the disposition of the error. The initial value for the error flag is 1 to signify a new error. f the same error is detected on subsequent runs, the enor flag is set to 2. All unresolved errors (flag values other than 1) for a particular study are printed on a separate report whenever the system is executed for that study. CRA Report Generation As part of the error resolution process, some errors are detected which cannot be resolved by the Clinical Data Manager and therefore must be returned to the Clinical Research Associate for resolution by the investigator. As a part of the edit checking system, the Clinical Data Manager is given the capability of selecting which errors are to be returned to the CRA for correction and producing a report containing only those errors. The fu"st. major beneflt achieved from the conversion was the improvement of the user interface. All version 5.18 SAS/~ menus were replaced by version 6.06 SAS/AF PROGRAM entries. PROGRAM entries were chosen over MENU entries because they provide the developer with greater control over the "look and feel" of the application. n this system, menu items and screen options are selected with TAB and EN'ER keys. Using PROGRAM entries for menus ensures that this "feel" is constant throughout the application. Another major improvement to the system was made through the use of the sa.. selection list functions. Extensive use was made of the functions for variable lists, SAS dalaset contents, and SAS dataset names. The "pop-up" window (Figure 3) nature of these functions allowed us to provide the user with immediate access to needed information while maintaining the quality of the user interface. These features provided the greatest improvement in user response time. Figure 3. The SO.. function CURWORD allowed us to place the tags RUN and CANCEL on every non-menu screen. These tag frelds relieve the user from having -- Once these errors are selected, the results listing is processed to extract the designated errors and replace variable names with their english labels from the data dictionary for that study. At this time, the flag in the audit trail is changed to '3' to indicate that the error bas been returned to the CRA. Using these reports, the Clinical Data Manager can accurately and efficiently detect, resolve and track data errors. Benefits Achieved from Version 6 Conversion This system was originally developed using version 5.18 of the SAS System for V AXNMS and was later rewritten using version 6.06 of SAS for VMS. Version 6.06 provides VAX users with the advanced capabilities of Screen Control Language and the SAS Macro facility. to remember which keys cause the action to be taken or cancelled. Since the tags are reached by using the TAB key, the developer can disable the COMMAND line thereby preventing the unsophisticated user from inadvertently leaving the application incorrectly. The direct dataset bandling functions in sa.. also proved to be extremely beneflcial. These fwtctions provide the developer with the ability to verify a user's screen entries and provide immediate feedback when errors are detected. n the version 5 system, the user's entries were validated in subse-

3 274 Phannaceutlcals ndustry Applications quent data step processing. These direct data handling functions not only allowed us to provide immediate feedback to the user but also alleviated the need to keep several versions of a SAS dataset to meet different table lookup and validation needs. For eumple, in the version S system, the code displayed in the attached Figure 4, was n~ to del~te a set of logic statements and update the mdex. Wllh the ani val of version 6, the same task was completed in a single PROGRAM entry as given in attachment FigureS. n addition to the features discussed thus far, version 6.06 SCL has functions which interface with the VMS operaling system.lnre-writting the edit-check ing system, we made use of some of these functions to pecform system level operations from within the application. This proved most beneficial when we wanted to hide the operating system from the user who may not know how to correctly interpret VMS messages. Another benefit version 6 brings to the SAS developer in lhe VMS environment is lhe ability to effectively and efficiently construct modular systems. Prior to the mival of version 6 on the VAX, modular systems were built by writing SAS code that generates olher SAS code and then using %NCLUDE statements to execute that code. Parameters were passed by generating %LET statements to a flat file and then including the %LET statements for execution. 1be success or failure of a production system built in this manner rested solely on the degree of professionalism displayed by the developer and on a good, comprehensive set of coding conventions that are strictly adhered to. While there is no substitution for good coding practices, version 6.06 wilh SCL and Macro does make the developer's life a little easier. Modular code is now simpler to generate by taking advantage of the CALL DSPLAY feature of SCL, the availability of the full Macro language and the AUTOCALL libraries. Parameter passing is now less cumbersome in that they can be passed from screen to screen in an AF application through the use of the EN1RY feature or through standard macro variables. Conclusion This paper discussed the features of version 6.06 of the SAS System that have been used by Fidia programming staff to date and the benefits achieved thus far. The edit-checking system is not yet complete in that there are several enhancements waiting to be made. As time goes on and we learn more about the features and functions available in version 6 and how to best take advantage of them, we expect to see greater benefits and improvements in our systems. SAS and SAS/AF are registered ttademarlcs of SAS nstitute nc., Cary NC, USA. VAX and VMS are registered ttademarlcs of Digital Equipment Corporation, Maynard MA, USA. References SAS Screen Control Language: Reference, Version 6, First Edition. SAS Technical Report P-199, Using SAS Screen Control Language in Release 6.06 The author can be reached ac Fidia Pharmaceutical Corporation 1775 K StreetN.W. Suite800 Washington, DC (202)

4 Pharmaceuticals ndustry Applications 275 Figure 2: Edit-checking Results Listing ********************************************************* * EDT CHEC<NG :RESUin' FOR mta SE': C8711V AND USNG F»fiLY SE': C8711AE * ********************************************************* m STE#= 1 PATENl' NUMBER= 103 VST CODE= 40 FADRE: ( ( AERECDl»;:2 4 AND AEREO:Ml. NE 1 C 1 ) OR ( AERECDl ll' 4 AND AEREO:Ml. NE ) ) AND VSa> NE 0 AND VSCO NE 120 AERECDl = 1 AEREO:Ml. = C AERECX:Ml = C VSCO = 40 m STE#= 1 PATEN' NUMBER= 105 VST CODE= 40 FAJRE: ( ( AERELCD1»;:2 4 AND AERECX:Ml NE 1 C 1 ) OR ( AERELCD1 ll' 4 AND AEREO:Ml. NE ) ) AND VSCO NE 0 AND VSCO NE 120 AERELCD1 = 2 AEREO:Ml. = C.AEREO:Ml. = C VSCO = 40 m STE#= 1 PATEN' NUMBER= 107 VST CODE= 40 F1UJRE: (( AERELCD1 EQ 4 AND AEREO:Ml. NE 1 C 1 ) OR ( AERELCD1 ll' 4 AND AEREO:Ml. NE ) ) AND VSCO NE 0 AND VSCO NE 120 AERELCD1 = 2 AEREcnn = C.AEREO:Ml. = C VSCO = 40 m STE#= 1 PATEm' NUMBER= 109 VST CODE= 20 FAJRE: ( ( AERELCD1 EQ 4 AND AERECX:M1 NE 'C 1 ) OR ( AERELCD1 ll' 4 AND.AEREO:Ml. NE ) ) AND VSCO NE 0 AND VSCO NE 120 AERELCD1 = 2.AEREO:Ml. = C AERECX:Ml = C VSCO = 20 m STE#= 1 PATEN' NUMBER= 110 VST CODE= 20 FAJRE: ( ( AERELCDl»;:2 4 AND AEREO:Ml. NE 1 C 1 ) OR ( AERELCDl ll' 4 AND AEREO:Ml. NE ) ) AND VSa> NE 0 AND VSCO NE 120 AERELCD1 = 2 AEREO:Ml. = C AERECX:Ml = C VSCO = 20 * l ,_...,_,,,... _,......

5 276 Pharmaceuticals ndustry Applications Figure 4: version 5.18 ************************************************************* * DEJ:.O)DE. SAS. * 1*************************************************************1 filename tt 'tt.sas'; data _null_; %inc tt; file tt; if "&c:hdans"='yes' OR ''&chdans"='y' then p.rt "x 'delete duao: [prcgram.newedi.t.mata]&fcx:d. ssd;*' :"1 '%let nfood= :'1 1 %inc dellist; i else p.rt 'proc display o=dir.newedit.delccxiel.pro;jtam;'; ************************************************************/ * DETJ:TST.SAS */ ************************************************************ filename tt 'tt.san' r data ma.ta. fcx:dlist; set ma.ta.fcodlist eoo=last; if code="&foxl" then delete; prcx::: sort data=mata. fcodlist; by cx:de; data ma.ta.fcx:dlist; set ma.ta.fcodlist; x==_n_; proc transpose data=mata.fcx:dlist out=dir.tranlist name=x; id code; data _null_; file tt; put "%let food= &nfcxxi... %inc tt;

6 Pharmaceuticals ndustry Applications 277 l!figure 5: Version i 6.06 dsid = open('ndata.fcodlist','u'); vnum = vaznum(dsid, 'fname'); rc = loc:atec(dsid,vnum,fcod); if rc then do; L... _ recno = fetchobs(dsid,rc); del = syngetn ('delete') ; if del = 1 then do; dname = 'ndata. fcod; rc = delete (dname) ; if rc A= o then do; _msg_ = sysmsg () i refresh; else do; _msq_ = 'Family Set fcod rc = delobs ( dsid) ; if rc then _msg_ = sysmsg () ; refresh; ' has been deleted.';