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