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Design of Data Entry SystemsDesign of Data Entry Systems

Pam Kellogg,Research Informatics,

Family Health International

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Data Entry Design TopicsData Entry Design Topics

CRFsAnnotated CRFsRecord LayoutsData DictionariesCode listsData entry screensTestingQADocumentation

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CRFsCRFs

Upon receipt of a final copy of the CRFs, the Data Programmer will begin the database design of CRFs used for data entry

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Final Copy of CRFsFinal Copy of CRFs

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Annotation of CRFsAnnotation of CRFs

Use a standard convention in the naming of variables – e.g. the first two letters of the item refers to the name of the CRF Assign variable names to all header (center number, participant number, date) information on each page of a CRF

Use a standard convention in the naming of code(s) – e.g. a three letter prefix_code nameYou may want to use color coding to differentiate your variables and codes

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Record LayoutRecord Layout

What the database structure should be

CRF name Variable name assigned on the CRFVariable name descriptionVariable type (e.g., numeric, character, date)Code name if one is assigned to variable

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Code(s)Code(s)

Set of codes and corresponding values are assigned to itemsSuggested to create individual code(s) per protocol or studyMay require data entry of codes or valuesExample of a code: codes 0, 1 and 2 for values no, yes and not applicableUse a uniform naming convention for code(s)

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Code assigned to an itemCode assigned to an item

Values of 1=Yes, 2=NoValues of 1=Yes, 2=No

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Data DictionaryData Dictionary

What the database structure actually is

Generated from your data entry system design programCompare to record layout for QA

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Exclusion FormExclusion Form

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Adverse Event FormAdverse Event Form

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Data Entry ScreenData Entry Screen(Study Page) (Study Page)

Electronic software generated representation of a CRFServes as a data entry screen to store dataTypically data is stored as one recordSome CRFs require design of data storage of multiple records

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One Record Per ParticipantOne Record Per Participant

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Multiple Records Per ParticipantMultiple Records Per Participant

•Rows of data are entered •Rows repeat

•Each row creates a record

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Data RetentionData RetentionOne record per participant CRFOne record in one tableEach row is a unique subject – Row 1 shows the record for PN (Participant Number) #1150, Row 2 shows record for PN #1006

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Multiple Records Per Participant Multiple Records Per Participant

Multiple records stored in one tableEach row entered creates an additional record for the same participant – PN #2026 has three rows of data or three records

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Multiple Records Per Participant Multiple Records Per Participant -- DesignDesign

Another example of design and data retention of a CRF with multiple records per participant Each group of repeating rows create a new table A participant may have one record in multiple tables

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Multiple Records Per Participant Multiple Records Per Participant --RetentionRetention

Another example of retention of multiple recordsMultiple records stored in separate tables Main Table and TODAY

FALSEFALSEFALSEFALSEFALSE21423/21/2006

FALSETRUEFALSETRUETRUE4999994/21/2006

QUMEUSE5QUMEUSE4QUMEUSE3QUMEUSE2QUMEUSE1QUTIMESQUSID2QUDATE2

Main Table

TODAY Table

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Testing of Data Entry PageTesting of Data Entry Page

Enter one or two participants per CRF Enter all itemsEnter multiple records for a participant on multiple record CRFsExtract the data entered and check for integrityCreate a dataset and check for accuracy

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Quality Assurance CheckQuality Assurance Check

Check that all items on the CRFs, record layouts and in the database software system matchCheck that all data types are correct for each item createdCheck page(s) created for accuracyCheck for correct data structure for each CRF

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Documentation of DesignDocumentation of Design

Document your Work by placing a set of the final CRFs, the record layouts, test data, dataset results and various system generated reports in a Study Notebook