Clinical Data Interchange Standards Consortium (CDISC) was formed in the year 2000 to develop and support global, platform-independent data standards that enable standard data format to support the exchange of clinical data among organizations or within the organizations such as pharma, medical device companies, CR Organizations and regulatory agencies. SDTM (Standard Data Tabulation Model) defines the standard format for tabulating the data. In any pharmaceutical industry there are three approaches for implementing SDTM standards: they are pure SDTM, submission only and database only. |
Pure SDTM: All study data that is from data capture to analysis and submission should be following the SDTM standards.
Submission only SDTM: Only at the time of submitting the data to Regulatory Authority, the data should be in SDTM format.
Database only SDTM: while the data is uploaded into a database, it should be in SDTM compliance.
Clinical Data Acquisition Standards Harmonization (CDASH) is also a user guide, which is helpful in understanding the basic recommended standards for the collection of clinical trial data. This documentation is useful for those who are involved in planning, collection, management and analysis of the clinical trial data. For example Clinical Investigators, Medical Monitors, Clinical Research Associates (Monitors), Clinical Research Study Coordinators, Clinical Data Managers, Clinical Data and Statistical Programmers, Biostatisticians, Drug Safety, Case Report Form (CRF) designers and any others who are involved in the trial data processes should be aware of CDASH.
SDTM domains can be categorized in four main categories. They are Interventions, Events, Findings and Special purpose.
Some of the domain names are as follows:
Adverse Events (AE), Inclusion and Exclusion Criteria (IE), Comments (CO), Laboratory Test Results (LB), Prior and Concomitant Medications (CM), Medical History (MH), Demographics (DM), Physical Examination (PE), Disposition (DS), Protocol Deviations (DV), Drug Accountability (DA), Subject Characteristics (SC), ECG Test Results (EG), Substance Use (SU), Exposure (EX), Vital Signs (VS)
A Clinical Data Repository / Warehouse (CDR/CDW) are real time databases that consolidate data from a variety of clinical sources to present a unified view of a single patient data. It is optimized to allow retrieving data for a single patient rather than identifying a group of patient population with common characteristics.
Clinical Data Repository (CDR) is the repository for collected data, derived data and protocol level metadata. CDR supports the audit trail, business logic/database derivations, frozen files, study pooling, vocabulary levelling, medical monitoring, and metadata-controlled blinding/un-blinding. Another feature of CDR is fully enabled standards based data exchange with other internal and external systems. For analysis and reporting, data is extracted from CDR and transformed into SDTM and SDTM extension to SAS datasets in another environment on the SAS platform. This achieves the industry standard format now required for SAS datasets.
As a part of clinical Data Management, the patient’s data is captured using eCRF through electronic data capture (EDC).It is then mapped to SDTM format prior to loading into CDR. Derived variables are created in the CDR based on clinical data dictionary. Then, study metadata is applied. For example drug formulation is stored as study metadata. Upon data extraction, the data is transformed from the CDR to SAS SDTM and SDTM extension formatted datasets, each dataset representing an SDTM domain.
Finally, after data extraction, analysis and reporting is performed on a SAS platform.
Correct SDTM mapping and business rules application are essential for successful implementation of SDTM for clinical data. As a result user acceptance testing (UAT) for SDTM mapping is done using SAS. The SAS based UAT process allows for easily replicated and documented testing. Once the testing phase has successfully concluded, SDTM implementation is successful.
During UAT, the SAS programmer performs the testing. Other technical personnel are involved with the implementation of SDTM mapping standards, clinical data dictionary standards and phasing on test data. SAS is used by the tester to compare mock or test data to the SDTM mapping specifications. Once the mapping has passed testing, SAS programmers then check that clinical data dictionary standards and phasing are implemented correctly in CDR. Results can easily be saved as SAS log and list files as evidence of successful testing.
SDTM standards according to CDISC and CDASH which are accepted universally for clinical trial data has created an unified platform for sponsors and regulatory authorities to speed up the clinical data submission, acceptance and approvals.
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CDISC, SDTM, CDASH, Standards, Clinical Trial, Data, Clinical Data, Data Repository, collected data, derived data, protocol level metadata, Mapping,