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Electronic CRF DesignElectronic CRF Design

Erik Jolles,Senior Data Manager,

Family Health International

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DefinitionsDefinitions

eCRFs are the electronic representation of paper data collection formsThese can be duplicated from paper data collection forms or can themselves be the tool that is used for data collection

Data Entry screenData Fax entry screens (OCR,ICR)EDC – Entry screens

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Some general GuidelinesSome general Guidelines

eCRFs should be very similar to paper CRFsShould mimic the design and flow of paper CRF

eCRFs should have built-in edit checks tagged to each data field and also tagged to the form as a wholeIf there are no paper CRFs majority of the data cleaning will take place during the completion of the eCRFs.

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Things to ConsiderThings to Consider

Ease of entryAvoid over crowdingMatch electronic form to paper form as much as possibleUse of pre-coded answer setsAvoid excessive use of text fieldsAE designs

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Ease of data entryEase of data entry

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PrePre--coded Answer Setscoded Answer Sets

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Radio ButtonsRadio Buttons

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Check BoxesCheck Boxes

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DatesDates

Dates can be designed to be entered as a single item; however, you may have problems with incomplete datesFHI uses separate items for each part of the date and a derivation to get the dateWe also need to keep in mind the format that the dates will be collected (e.g., dd/mm/yyyy, mm/dd/yyyy, dd/mon/yyyy) and set up the screens appropriately.

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Repeating RecordsRepeating Records

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Text FieldsText Fields

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Text Fields (2)Text Fields (2)

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Testing of eCRFsTesting of eCRFs

eCRFs should be tested for ease of entry and data cleaning programsElectronic checkTab orderOrder of items on the formAnswer sets (code lists)

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Tools for testingTools for testing

Test data – to test error specifications and train data entry staffData base specificationsList of tablesError specification documentVariables and formats in each tableList of pre-coded answer sets (codelists)Expected error matrix

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ConclusionsConclusions

Design eCRFs as you would paper CRFsError checks should be tested for each eCRF and tested with test dataeCRF should be reviewed not only by study team but also by data entry staffStore documentation of for the design of the eCRFs