Tuesday, July 21, 2009

SDTM, ADaM Domain Datasets Generation

With the latest release of the updated CDISC SDTM and ADaM standards, most of the members of the Pharma industry are all in common talking the same issues. How and when does the creation of SDTM files occur during the clinical trial process? What files should be used to create analysis files? How do I keep track of all of the data transformations? The possible services listed below will offer some solution and considerations on how to implement CDISC standards within a pharmaceutical organization with respect to domain datasets generation which are submitted to FDA. A discussion of the types of software solutions that can be used to perform the transformation of data into the SDTM is worth gaining an insight

For most submission, both the CRF data and the analysis datasets are submitted to the FDA as part of a new drug application. Now that the CDISC standards have been developed and endorsed by the FDA, many companies are reengineering their internal processes to adopt them. As complex as the development of the standards was, the implementation will prove to be equally as complex. This paper will discuss some of the issues to consider when implementing both the SDTM and ADaM standards. Suggestions presented here should be considered as such since each organization must develop an implementation roadmap that best fits their environment.

Possible SDTM, ADaM Domain Datasets Generation Services
  • Complete CDISC SDTM and Lab Terminology implementation
  • In-built functions for combining data
  • Domain and variable properties editing
  • Mappings on test clinical data testing
  • Transformation code generation
  • Execution of transformation code on clinical data
  • Creating SQL statements to ensure creation an SDTM database
  • Populating SDTM database with created SDTM records in a organized way


Tuesday, May 12, 2009

CDISC Mapping Specification Domain

At MaxisIT the first step in the CDISC mapping specification document service employs the comparison of the study metadata on par with the SDTM domain metadata.

In complex studies where the CDM metadata was most suitable to the maximum extent possible with SDTM metadata, it is recommended to make use of automated mapping as a first step. Then If CDISC standard data sets and variable names were properly arranged in the CDM data sets, it is more suggested to use a data step or SQL select to verify for direct matches and document then so that the validity of the mappings can be mapped.

This procedure only serves as a first step of SDTM metadata mapping, but it can purposefully eliminate hours of manual mapping. If the CDM metadata is not mapping with the SDTM metadata or if SDTM specifications were improperly used, then auto mapping is suggested to be avoided as the best choice

The successive step at MaxisIT in this service area employs manual mapping of the study data sets to the actual domain data sets and then there by mapping each single variable to the appropriate domain. Varying on how the CDM data is structured, you may have a facility to map each CDM file to every suitable single domain, and ensure a split its variables among multiple domains, or a combination of variables from multiple CDM files into a single existing domain. There are many types of variable mapping possible.

Several basic types of mapping at MaxisIT are listed below:

Direct mapping


Monday, May 11, 2009

CDISC Services

MaxisIT has a very deep understanding of CDISC standards and services and believes these help in achieving the miracles in driving the clinical research process. Hence we provide a number of services on the lines of CDISC.

MaxisIT CDISC Services:

CDISC mapping specification document
SDTM, ADaM domain datasets generation
Applications development using CDISC standards
Legacy study conversion
ISS/ISE studies standardization
Comprehensive validation of SDTM & ADaM datasets
Define XML document
eCTD development & validation
CDISC training