Case Report FormDesign Issues

Phyllis RathmanBiotechnical Services, Inc.

www.biotechnicalservices.com

IntroductionGarbage in = Garbage out?Using Case Report Form (CRF)design guidelines to provide qualitydata

Topics of DiscussionTiming of the CRF design processParticipants in CRF designGoals of CRF designSelected CRF design guidelinesExamples: good and not so goodProcess improvementResources

Timing of the Design ProcessDuring protocol development

Pro: identification of problems with protocolprocedures prior to protocol finalizationCon: numerous versions of CRFs may benecessary

After protocol finalizationPro: fewer versions of CRFs and fewerreviews prior to finalizationCon: if issues between CRF/data andprotocol arise, protocol amendment may berequired

Participants in CRF DesignCRF DesignerStatisticianMedical Director for studyDatabase Designer/ProgrammerClinical MonitorInvestigator/Site CoordinatorData Entry Personnel

Goals of CRF DesignCheck logistics, design, andpracticality of the protocolExpedite accurate processing,analysis, and interpretation of dataCheck protocol adherence and/orinvestigator complianceFulfill regulatory requirements

Cato, A., and Cook, L. (1984)

Selected CRF Design Guidelines

Use well-known terminology andabbreviationsRemember that some terms havedifferent meanings to different peopleProvide definitions when necessaryWhen a comparative judgement isrequired, define the basis for thecomparison

Language and Terminology

Language and TerminologyExample

Selected CRF Design Guidelines

Specify unit of measurementIndicate the number of decimal placed tobe recordedIf an average value is to be calculated,create a place on the CRF for thecalculationIndicate how measurements should becollected (rectal vs. oral temp., sitting vs.supine BP)

Measurements/Calculations

Measurements/CalculationsExample 1

Measurements/CalculationsExample 2

Selected CRF Design Guidelines

If using 24-hr clock times, indicate assuch on the CRFIf using 12-hr clock times, include AMand PM check boxesCollect dates in the same format (USor European) on all CRFsIf complete dates are required, clearlyindicate this on the CRF

Times and Dates

Times and Dates Example

Selected CRF Design Guidelines

Use “continuing” boxes for therapy,treatment, or AEs that may continue paststudy completionCapture the reason for each therapy,treatment, procedure, etc.Use AE prompts on applicable CRFs(concomitant therapy, procedures,treatments, exams, etc.)Avoid capturing the same piece of datain more than one place on the CRFs

Miscellaneous

MiscellaneousExample 1

MiscellaneousExample 2

Process ImprovementDefine your organization’s processfor CRF designAfter study completion evaluateand document which CRFs workedwell and which did notGet input from others involved inCRF design inside and outside ofyour organization

ResourcesSpilker, B., and Schoenfelder, J. (1991). DataCollection Forms for Clinical Trials. New York, NY,Raven Press.Good Clinical Data Management Practices, Version 3,September 2003, Society of Clinical DataManagement.Drug Information Association (www.diahome.org)Society for Clinical Data Management(www.scdm.org)

Summary

Determine thebest time for theCRF designprocessInvolve the rightpeopleKnow the goals ofCRF design

Apply CRFdesign guidelinesInclude processimprovement aspart of CRFdesignSearch outresources

To ensure quality data, applyCRF design principles: