Data Management In Clinical Trials

Data Management in Clinical Trials Avijit Hazra Department of Pharmacology IPGME&R, Kolkata

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Agenda  Data

management overview.

 Data

management components.

Data acquisition Data entry Data privacy Data storage / archival

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Role of data management  Primary

role. Ensure data integrity and reliability.

 Secondary

roles.

Accelerate timeline from data collection to analysis. Use standard reporting and communication. Educate users.

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Role of data management

Can Can be be achieved achieved only only through through close close cooperation cooperation 4

Data acquisition 1  CRF

is arguably the most important CT document after the protocol & ICF.  Design, development and QA of the CRF is of utmost importance.  Should be designed concurrently with the protocol and may be given field trials.  Should capture raw data rather than calculated data.  Should not collect redundant data and need not capture extra data.

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Data acquisition 2  Manner

of data collection:

Open: Free text, numeric, alphanumeric. Closed: Check-boxes, multiple choices. Analog / rating scales.  Variables

must be adequately defined so that data collected is precise and unambiguous.  Coded formats are preferred and the coding sequence should be as uniform as possible.  Avoid blank items.  Follow writing and correction protocols.

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Data acquisition 3  Arrangement

of data elements in the CRF should follow the study flow but there are sections spanning multiple visits (e.g. concomitant medication) to fill up which reminder check boxes should be in place.  Consider education level, intelligence, etc. if patient is completing CRF sections (e.g. Subject Diary).  Unique identifier, dates and signatures.  Avoid RETROSPECTIVE filling.

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Data acquisition 4

Avoid RETROSPECTIVE filling.

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Data acquisition 5 CRF Completion Guidelines – – – – – – –

General instructions Use of permanent ink on CRFs List of abbreviations Contact information All items to be complete Procedure for making corrections on CRF Procedure for visits of CRFs that are not done

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Data acquisition 6 Paper vs. Electronic Electronic CRFs can/do facilitate clean data due to functionality of application.  Force format for data as it is entered.  Limit responses to list of values, also force a response so blanks are not allowed.  Coding of AEs / Medications.  Use of conditional logic for navigation.  Discrepancy management features.  BUT - Always have backup (paper) if system fails and visit is time critical. 10

Data entry 1  Vital but often relatively neglected aspect

of CT data management.  Correcting data entry errors can be costly.  Anomalous values discovered during analysis will bring analysis to a standstill.  The only thing worse is failure to detect errors, resulting in distorted results & publication. 11

Data entry 2  Units & decimal points are to be treated

with utmost respect.  Large trials allow a period of data cleaning, verification and clarification before analysis is commissioned.  Data entry methods: Single entry with no verification. Single entry with manual verification. Double entry with blind verification. Double entry with interactive verification. Double entry with independent verification.

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Data entry 3

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Data privacy 1 Refers to standards surrounding protection of personal data.  Design CRFs with minimum number of personal identifiers necessary.  If source documents are to be collected they must be stripped of personal identifiers and appropriate coding assigned.  Consider a CONFIDENTIALITY AGREEMENT for all persons with access to data. 14

Data privacy 2  Enforce

a NO UNAUTHORIZED ACCESS policy and evaluate all requests for information for a any purposed beyond that specified by the protocol and ICF.  Implement procedures to ensure privacy of data during transfer between departments, centers, agencies and countries.  Appropriate security measures for archiving of data whether paper or electronic.

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Data storage 1 Data storage / archival needs to be SECURE and EFFICIENT.

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Data storage 2  Risk of data corruption and version

conflict errors increase with data transfer operations.  CRFs, Source documents, Raw data, Final data sets, Database design documentation all need to be preserved.  Physical security must be guaranteed. 17

Data storage 3  Both paper and electronic data are likely

to be stored locally on-site as well as centrally. Access control protocols are essential.  Electronic data can be readily backed-up to appropriate media that can be stored off location.  Electronic data can be encrypted but open format storage has its advantages. 18

Don’t let poor data management steal your trial !

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