Table 1: Biostatistical methodologies and their key functions.
Model for Planning |
|
PRM (Protocol Representation Model) |
The PRM captures information as data instead of text in a protocol and helps create case report forms (CRFs) and study outlines |
ODM (Operational Data Model) |
The ODM standard plays a key role in clinical research informatics, including areas such as data exchange, archival, U.S. Food and Drug Administration (FDA) submission, and inter-operability with healthcare data. |
Data Collection |
|
CDASH (Clinical Data Acquisition Standards Harmonization) |
CDASH organizes clinical data into interventions, events, findings, and special purposes. |
Data Tabulation |
|
SDTM (The Study Data Tabulation Model) |
SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis, and reporting. |
Data Analysis |
|
ADaM (Analysis Data Model) |
ADaM datasets provide significant information about individual studies and the derivation decisions made in each study. |
Data Validation |
|
SAS (Statistical Analysis Software) |
SAS is a command-driven software for data manipulation, statistical description and inference, and data presentation. |
ARDM |
ARDM facilitates the tracking, searching, and retrieving of outputs as it enables query-based searches. |
Submission for approval |