Flow Of Data In Clinical Trials - Chalmers

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Flow of data in clinical trialsData management

ProtocolCRF DesignPatient data collected inCRFsPatient data in CRFsconverted into raw datasetsRaw datasetsCreate analysis data setsCreate TLFsReport

DMDMSTPR

Clinical data management (CDM) Clinical data management is a critical phase in clinical research,which leads to generation of high-quality, reliable, and statisticallysound data from clinical trials. Clinical data management assures collection, integration andavailability (transfer) of data. It also supports the conduct, management and analysis of studies.

Subject Data Collection Data is collected on case report forms (CRF) Much of clinical data is taken from the subjects medical record(source documents) Pharmaceutical and device trials, data is verified by multiple players A good protocol leads to a simple, clear CRF, built from a standardtemplate: Restrictive

Can I trust the data generated? Accuracy Reliability Integrity – can’t be modified Availability – for staff and inspectors Authenticity – is it from the correct person Does the system do what it is meant to do?

CDISC standard The Clinical Data Interchange Standards Consortium leads thedevelopment of global, system independent data standards which arenow commonly used as the underlying data structures for clinical trialdata. These describe parameters such as the name, length and format ofeach data field (variable) in the relational database.

hbp://www.cdisc.org/sdtm/

Study Data Tabulation Model (SDTM) SDTM provides a standard for organizing and formatting clinical datato streamline processes in collection, management, analysis andreporting. SDTM is also used in non-clinical data (SEND), medical devices andpharmacogenomics/genetics studies.

SDTM SDTM is built around the concept of observations collected about subjectswho participated in a clinical study. Each observation can be described by a series of variables, correspondingto a row in a dataset or table. Each variable can be classified according toits Role: Identifier variables, which identify the study, subject of the observation, the domain,and the sequence number of the record Topic variables, which specify the focus of the observation (such as the name of a labtest) Timing variables, which describe the timing of the observation (such as start dateand end date) Qualifier variables, which include additional illustrative text, or numeric values thatdescribe the results or additional traits of the observation (such as units ordescriptive adjectives).

Dry Run? A dry Run (also called Blind Delivery Review) is conducted to allow the evaluationof the reporting datasets (SDTM/RDb) and statistical output tables, listings, andfigures (TLFs) prior to database lock, to ensure that all outputs are prepared asexpected as per agreement DM will deliver: SDTM; the reporting datasets; TLF outputs whilst the data is stillblinded Cross functional representation will be required to undertake review of theoutputs, and at the DR Comments Resolution Meeting (CRM), to ensure thesuccess of the DR11

What is the purpose of DR?The purpose of DR is primarily for verification of the assumptionsof the analysis methods detailed in the Clinical Study Protocol(CSP) and/or Statistical Analysis Plan (SAP) and to also include anassessment of:- Recruitment, i.e. to ensure the correct subject population is beingrecruited- Review of protocol deviations- Investigate any potential safety issuesAs a result of DR, the following changes may be needed:- Additional supporting tables may be considered(associated additional costs may apply)- Analysis set rules may be reviewed, changes in rules foranalysis sets documented in SAP amendment/addendum(optional format)- Analysis set rules may include updated rules related toprotocol deviations Planned analysis may need to change12

Clinical data management (CDM) Clinical data management is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integrat

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