Introduction

In April of 2012 the National Clinical Trials Network (NCTN) built their first trials into Medidata Rave.  Currently there are approximately 150 trials in Rave.  Within that implementation a number of areas were standardized including core configuration, business rules, and integration with selected other systems and use of common data elements.  Reusable Case Report Forms (CRFs) with edit checks and custom functions using local standards were developed by each NCTN Group. 

The CRF harmonization activity was a conceptual effort focused on the entire NCI research community and the standards identified were by design not intended for a particular CDMS system.  The emphasis was on the creating a set of content to be housed in a repository for general and public use.

The NCTN agrees in principle that harmonization of the human readable content (PVMs) and coded values (PVs) in Common Data Elements (CDEs) is important to improve efficiency and effectiveness of clinical trial data management, streamline the Rave study build process and ensure that data can be shared across the NCTN and with the National Cancer Institute (NCI).  The NCTN encountered a number of limitations with the use of NCTN standards during the Rave implementation.

The Network Rave Data Standards (NRDS) Committee is being established to facilitate the implementation of selected CDEs specifically in Rave.  The target audience will be the members of the National Clinical Trials Network (NCTN) and Experimental Therapy Clinical Trials Network (ETCTN).  The work will be led by the NCI and NCTN.

NRDS Bulletins

• February 2016 NRDS Bulletin

• August 2015 NRDS Bulletin

• July 2015 NRDS Bulletin

Working Group Members