Data Management in Clinical Trials

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Data Managementin Clinical Trials

Avijit HazraAvijit Hazra

Department of PharmacologyDepartment of PharmacologyIPGME&R, KolkataIPGME&R, Kolkata


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AgendaAgenda

Data management overview.Data management overview.

Data management components.Data management components.Data acquisitionData acquisitionData entryData entry

Data privacyData privacyData storage / archivalData storage / archival


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Role of data managementRole of data management

Primary role.Primary role.Ensure data integrity and reliability.Ensure data integrity and reliability.

Secondary roles.Secondary roles.Accelerate timeline from data collection toAccelerate timeline from data collection toanalysis.analysis.Use standard reporting and communication.Use standard reporting and communication.Educate users.Educate users.


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Role of data managementRole of data management

Can be achieved only through close cooperationCan be achieved only through close cooperation

Can be achieved only through close cooperationCan be achieved only through close cooperation


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Data acquisition 1Data acquisition 1

CRF is arguably the most important CTCRF is arguably the most important CTdocument after the protocol & ICF.document after the protocol & ICF.Design, development and QA of the CRF isDesign, development and QA of the CRF isof utmost importance.of utmost importance.

Should be designed concurrently with theShould be designed concurrently with theprotocol and may be given field trials.protocol and may be given field trials.Should capture raw data rather thanShould capture raw data rather thancalculated data.calculated data.

Should not collect redundant data andShould not collect redundant data andneed not capture extra data.need not capture extra data.


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Manner of data collection:Manner of data collection:Open: Free text, numeric, alphanumeric.Open: Free text, numeric, alphanumeric.Closed: Check-boxes, multiple choices.Closed: Check-boxes, multiple choices.Analog / rating scales.Analog / rating scales.

Variables must be adequately defined so thatVariables must be adequately defined so thatdata collected is precise and unambiguous.data collected is precise and unambiguous.Coded formats are preferred and the codingCoded formats are preferred and the codingsequence should be as uniform as possible.sequence should be as uniform as possible.Avoid blank items.Avoid blank items.

Follow writing and correction protocols.Follow writing and correction protocols.


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Arrangement of data elements in the CRF shouldArrangement of data elements in the CRF shouldfollow the study flow but there are sections spanningfollow the study flow but there are sections spanningmultiple visits (e.g. concomitant medication) to fillmultiple visits (e.g. concomitant medication) to fillup which reminder check boxes should be in place.up which reminder check boxes should be in place.Consider education level, intelligence, etc. if patientConsider education level, intelligence, etc. if patient

is completing CRF sections (e.g. Subject Diary).is completing CRF sections (e.g. Subject Diary).Unique identifier, dates and signatures.Unique identifier, dates and signatures.Avoid RETROSPECTIVE filling.Avoid RETROSPECTIVE filling.


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Avoid RETROSPECTIVE filling.Avoid RETROSPECTIVE filling.


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CRF Completion GuidelinesCRF Completion Guidelines General instructionsGeneral instructions Use of permanent ink on CRFsUse of permanent ink on CRFs

List of abbreviationsList of abbreviations Contact informationContact information All items to be completeAll items to be complete Procedure for making corrections on CRFProcedure for making corrections on CRF

Procedure for visits of CRFs that are notProcedure for visits of CRFs that are notdonedone


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Paper vs. ElectronicPaper vs. Electronic

Electronic CRFs can/do facilitate clean data dueElectronic CRFs can/do facilitate clean data dueto functionality of application.to functionality of application.

Force format for data as it is entered.Force format for data as it is entered.Limit responses to list of values, also force aLimit responses to list of values, also force aresponse so blanks are not allowed.response so blanks are not allowed.Coding of AEs / Medications.Coding of AEs / Medications.

Use of conditional logic for navigation.Use of conditional logic for navigation.Discrepancy management features.Discrepancy management features.BUT - Always have backup (paper) if systemBUT - Always have backup (paper) if systemfails and visit is time critical.fails and visit is time critical.


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Data entry 1Data entry 1

Vital but often relatively neglected aspectVital but often relatively neglected aspectof CT data management.of CT data management.

Correcting data entry errors can be costly.Correcting data entry errors can be costly.

Anomalous values discovered duringAnomalous values discovered duringanalysis will bring analysis to a standstill.analysis will bring analysis to a standstill.

The only thing worse is failure to detectThe only thing worse is failure to detect

errors, resulting in distorted results &errors, resulting in distorted results &publication.publication.


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Units & decimal points are to be treatedUnits & decimal points are to be treatedwith utmost respect.with utmost respect.Large trials allow a period of dataLarge trials allow a period of data

cleaning, verification and clarificationcleaning, verification and clarificationbefore analysis is commissioned.before analysis is commissioned.Data entry methods:Data entry methods:

Single entry with no verification.Single entry with no verification.

Single entry with manual verification.Single entry with manual verification.Double entry with blind verification.Double entry with blind verification.Double entry with interactive verification.Double entry with interactive verification.Double entry with independent verification.Double entry with independent verification.



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Refers to standards surroundingRefers to standards surroundingprotection of personal data.protection of personal data.Design CRFs with minimum number of Design CRFs with minimum number of personal identifiers necessary.personal identifiers necessary.If source documents are to be collectedIf source documents are to be collectedthey must be stripped of personalthey must be stripped of personalidentifiers and appropriate codingidentifiers and appropriate codingassigned.assigned.

Consider a CONFIDENTIALITY Consider a CONFIDENTIALITY AGREEMENT for all persons with accessAGREEMENT for all persons with accessto data.to data.

Data privacy 1Data privacy 1


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Enforce a NO UNAUTHORIZEDEnforce a NO UNAUTHORIZEDACCESS policy and evaluate allACCESS policy and evaluate allrequests for information for arequests for information for aany purposed beyond thatany purposed beyond thatspecified by the protocol and ICF.specified by the protocol and ICF.

Implement procedures to ensureImplement procedures to ensureprivacy of data during transferprivacy of data during transferbetween departments, centers,between departments, centers,agencies and countries.agencies and countries.Appropriate security measuresAppropriate security measures

for archiving of data whetherfor archiving of data whetherpaper or electronic.paper or electronic.

Data privacy 2Data privacy 2


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Data storage 1Data storage 1

Data storage /Data storage /archival needsarchival needs

to beto beSECURESECURE

andand

EFFICIENTEFFICIENT ..


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Risk of data corruption and versionRisk of data corruption and versionconflict errors increase with dataconflict errors increase with datatransfer operations.transfer operations.

CRFs, Source documents, Raw data,CRFs, Source documents, Raw data,Final data sets, Database designFinal data sets, Database designdocumentation all need to be preserved.documentation all need to be preserved.

Physical security must be guaranteed.Physical security must be guaranteed.


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Both paper and electronic data are likelyBoth paper and electronic data are likelyto be stored locally on-site as well asto be stored locally on-site as well ascentrally. Access control protocols arecentrally. Access control protocols are

essential.essential.Electronic data can be readily backed-upElectronic data can be readily backed-upto appropriate media that can be storedto appropriate media that can be stored

off location.off location.Electronic data can be encrypted butElectronic data can be encrypted butopen format storage has its advantages.open format storage has its advantages.


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Dont let poor dataDont let poor datamanagement steal your trial !management steal your trial !

Data Management in Clinical Trials

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