CDISC Blog  filter by date: February 2010

Landen Bain - Healthcare Link Updates

Landen went to Phoenix AZ for the first IHE face-to-face meeting of 2010.  The four day meeting was particularly productive. CDISC participates in the Quality, Research, and Public Health (QRPH, rhymes with Smurf) domain. The integration profiles under development that directly influence CDISC’s Healthcare link initiative are Retrieve Protocol for Execution (RPE) and Redaction Services. QRPH schedules its face-to-face meetings with two other IHE domains (there are 14 in all): Information Technology Infrastructure (ITI) and Patient Care Coordination  (PCC)...

Clear Messages from FDA CDER and CBER

by Dr. Rebecca Kush

There are some very clear messages coming from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).  As of a meeting with CDER and CBER Representatives and the CDISC Executive Committee on 1 February ....

Reasons to Celebrate - The Protocol Representation Model

Diane Wold of GSK gives her personal insights into the Protocol Representation Model

Those of us who started working toward a structured protocol representation in 2003 were motivated by the feeling that there had to be a better way to communicate information about a study than a text document.  The protocol is at the heart of clinical research, so it's just not effective or efficient for all the parties involved to extract data from text ...

Protocol Representation Model V1.0 - Now Released!

The CDISC Protocol Representation Model (PRM) Version 1.0 is released and available at http://www.cdisc.org/protocol.

The Model contains study protocol concepts such as Trial Design, Eligibility Criteria, and addresses the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries.  Additional protocol domain areas, activities, definitions ...