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Case Report Form Design Case Report Form Design

Erik Jolles,Research Informatics,

Family Health International

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GCP ConnectionGCP Connection

1.11 Case Report FormA printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor an each trial subject.

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CRF DesignCRF Design

Standard CRF Modulesperforming multiple studies in same research area

Design Standardsstandardize the “look and feel”

CRF Connectivitylink data from one CRF to another for analysis

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Standard CRF ModulesStandard CRF Modules

Reusable CRFs as templatesuseful starting point, customize as needed

Design goalsGather accurate data that answers study questions

avoid duplication of dataease of entry on CRFconformance with the study protocol

Ease of data entryEase of analysis

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Standard CRF ModulesStandard CRF Modules

Forms likely to use standard templatesInclusion/ExclusionAdverse eventsConcomitant medicationsProtocol Violation FormsFinal status

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Design StandardsDesign Standards

Header Study number - PreprintedSite numberParticipant numberForm ID – PreprintedForm Sequence Number (FSN) – PreprintedContact Date – Can preprint “20”

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Header Items Header Items

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GCP ConnectionGCP Connection

2.11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements.5.5.5 The sponsor should use an unambiguous subject identification code that allows identification of all the data reported for each subject.

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Design Headers Design Headers

Standardize naming convention for header items. Facilitates query of data

Reporting errorsTracking of errors at the sites

Facilitates reporting of dataTracking enrollment totals over time

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Electronic Form HeaderElectronic Form Header

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Standard Reports Standard Reports

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Screened Enrolled ReportScreened Enrolled Report

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Design StandardsDesign Standards

FooterStudy NameDateVersion numberPage number if necessary

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Design Standards Design Standards -- FooterFooter

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Design StandardsDesign Standards

Library of precoded answer setsYes/no/don’t know/not applicableMethod of administration of medicineSeverity of adverse event/experienceEducation level

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PrecodedPrecoded Answer Sets Answer Sets -- Visit Visit

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458678

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PrePre--coded Answer Setscoded Answer Sets

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Design StandardsDesign Standards

Guidelines for CRF designBoxes to hold answers

boxes provide visual cueslimit circling of answers (hard to interpret)

Specified density of questions on pageSeparation of columns with thick lines

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Design StandardsDesign Standards

Skip pattern informationBold, italicized instructionsLimit skips by placement of questionsTell where to skip TO, not what to skipSkip to “section name” not question number if possible

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CRF Design toolsCRF Design tools

WordExcelAdobe Page MakerOther

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CRFs in ExcelCRFs in Excel

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CRF ConnectivityCRF Connectivity

Standard method of linking CRFsBoxes that store the Form Sequence Number (FSN) of the related formOpen-ended text fields to hold list of FSNs separated by commas

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CRF Connectivity CRF Connectivity --Form Sequence Number (FSN)Form Sequence Number (FSN)

6-digit number (no leading 0)Assigned to each CRF

Same FSN for each sheet of multipage CRFFSNs are unique within each study

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GCP ConnectionGCP Connection

2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.

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CRF Connectivity CRF Connectivity --Review of CRFsReview of CRFs

Map all links between formsMultiple instances of forms can affect the linkageAre the links bi-directional?Are CRF dates used for linkage?

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CRF Design ConclusionsCRF Design Conclusions

Reusable modules enforce data integrity and efficiency of formsDesign standards improve quality of data collected and increase efficiency of data analysisCRF connectivity is crucial when planning complex analyses