Clinical Data Management

Priyanka VijayvargiyaPGDCTM, ClinimindsBhopal

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Data & Database•A collection of factual information derived

from measurement or research

•Collection of data is known as Database.

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Clinical data Management•Clinical data management involves the

collection, data entry, validation, clinical coding and transfer of clinical trial data.

•To provide clean data in useable format in timely manner.

•To provide a database fit for managing clinical data.

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Need for CDMEnsures integrity & quality of data being transferred from trial subjects to a database system.To provide consistent, accurate & valid clinical data.To support accuracy of final conclusions & report.

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Data Management Process•Protocol development•Data management plan•CRF designing•Database designing•Data entry•Data review & validation•Discrepancy management•Data base closure•QA/ QC•Data storage & archival

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Clinical Data Management Process

Protocol Data Management Plan CRF Design

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Database designingData EntryData review &

validation

Discrepancy Management

Database Closure OA/QC

Data Storage & archival

Data Management Plan

It helps to assess & plan for the study specific data management process.

It forms the backbone of overall quality system of data management.

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CRF designing•Before finalization, a pilot is carried out

with dummy CRFs to identify potential problems.

•Filled in by the investigator & forwarded to data management unit for entry & review.

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Database designing• It involves:

▫ Data flow into system either manually or electronically.▫ Creating global database▫ Validation/ derivation procedures▫ Data extraction programs & reporting

• Also:▫ Integration of dictionaries▫ AE reporting systems

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To capture & store clinical data accurately.

Data entry•Transferring data from paper CRF to

database.•Also known as transcribing the data.

•2 types of data entry:▫Double entry- entry of same CRF page by 2

independent personnel

▫Single entry- entry by single data entry personnel. It is extensively used in EDC/ RDC systems.

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Cont.•Other type of data

entry involves:▫Local data entry- done

at site & transmitted periodically to the central database.

▫Online data entry- data entry directly into central database via internet

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Data review & validation•Reviewed by data editor to address &

resolve the discrepancy.•Validation refers to data cleaning.

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Types of checks:• Point-by-point checks• Missing data/ blank field checks• Data consistency checks• Laboratory data & range checks• Hematology record• AE record• Discrete value group discrepancy checks• Header inconsistency checks• Missing pages check or CRF tracking• Protocol violation checks• Dates out of sequence checks• Continuity of data checks• Coding checks• External data checks• Duplicate data checks• Textual data checks• SAE reconciliation checks

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Discrepancy management •Following actions can be taken based on

project specific guidelines:▫Closing discrepancy per internal correction▫Generating a query to the investigator

Creating queries Sending queries Tracking queries Resolving queries Re-querying

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Database Closure•To prevent unauthorized or inadvertent

changes to the database.•Also known as soft-locking.•Done after last patient last visit (LPLV).•Change control procedures in case of

database unlocking.•Finally, the database is closed.

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QA/QC

•To ensure compliance with protocol, GCP, SOPs & applicable regulatory requirements.

•Two types:▫Interim analysis- while the study is ongoing.▫Final analysis- done after completion of

LPLV.

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Data Storage & Archival•Open formats such as CDISC or PDF are

recommended.

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Software used in CDM

•OpenClinica•Aris Global software solutions for life

sciences•SyMetric Sciences•Oracle•DMSys•Progeny Clinical

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2 elements of data management

•A validated computer system•Highly professional specialist staff

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CROs involved in Data Management

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