There is a general consensus that the old paper-based data management tools and processes were inefficient and should be optimized. Electronic Data Capture has transformed the process of clinical trials data collection from a paper-based Case Report Form (CRF) process (paper-based) to an electronic-based CRF process (edc process).
In an attempt to optimize the process of collecting and cleaning clinical data, the Clinical Data Interchange Standards Consortium (CDISC), has developed standards that span the research spectrum from preclinical through postmarketing studies, including regulatory submission. These standards primarily focus on definitions of electronic data, the mechanisms for transmitting them, and, to a limited degree, related documents, such as the protocol.
Clinical Data Acquisition Standards Harmonization (CDASH)
The newest CDISC standard, and the one that will have the most visible impact on investigative sites and data managers, is Clinical Data Acquisition Standards Harmonization (CDASH).
As its name suggests, CDASH defines the data in paper and electronic CRFs.
Although it is compatible with CDISC’s standard for regulatory submission (SDTM), CDASH is optimized for data captured from subject visits, so some mapping between the standards is required. In addition to standardizing questions, CDASH also references CDISC’s Controlled Terminology standard, a compilation of code lists that allows answers to be standardized as well.
Example: Demographics (DM)
|Date of Birth*
||dd MMM yyyy
*CDASH recommends collecting the complete date of birth, but recognizes that in some cases only BIRTHYR and BIRTHMO are feasible.
* *This document lists four options for the collection of Sex: Male, Female, Unknown and Undifferentiated (M|F|U|UN). CDASH allows for a subset of these codelists to be used, and it is typical to only add the options for Male or Female.
The common variables: STUDYID, SITEID or SITENO, SUBJID, USUBJID, and INVID that are all SDTM variables with the exception of SITEID which can be used to collect a Site ID for a particular study, then mapped to SITEID for SDTM.
Common timing variables are VISIT, VISITNUM, VISDAT and VISTIM where VISDAT and VISTIM are mapped to the SDTM –DTM variable.
Note: Certain variables are populated using the Controlled Terminology approach. The COUNTRY codes are populated using ISO3166 standards codes from country code list. This is typically not collected but populated using controlled terminology.
Each variable is defined as:
- Highly Recommended: A data collection field that should be on the CRF (e.g., a regulatory requirement).
- Recommended/Conditional: A data collection field that should be collected on the CRF for specific cases or to address TA requirements (may be recorded elsewhere in the CRF or from other data collection sources).
- Optional: A data collection field that is available for use if needed
The CDASH and CDICS specifications are available on the CDICS website free of charge. There are several tool available to help you during the mapping process from CDASH to SDTM. For example, you could use Base SAS, SDTM-ETL or CDISC Express to easily map clinical data to SDTM.
In general you need to know CDISC standards and have a good knowledge of data collection, processing and analysis.
With the shift in focus of data entry, getting everyone comfortable with using a particular EDC system is a critical task for study sponsors looking to help improve the inefficiencies of the clinical trial data collection process. Certainly the tools are available that can be used to help clinical trial personnel adapt to new processes and enjoy better productivity.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.