Clinical Data Update. New CDASH1.1 available for download!

In the sprit of realizing the vision of a set of end-to-end harmonized standards for the collection and submission of data from clinical studies, this standard describes the basic recommended (minimal) data collection fields for 18 domains, including common header fields, and demographic, adverse events, and other safety domains that are common to all therapeutic […]

FDA Audits of Electronic Records is Delayed for Clinical Trials – ???

An FDA plan to audit the growing use of electronic records by the pharmaceutical industry has been delayed by at least several months due to bureaucratic snags, although an agency official says the widely anticipated effort is still expected to get under way soon. At issue is industry compliance with a regulation known as 21 […]

6 Screens from ClinPlus DM

When your using a clinical data management system, screen design and flexibility are very important. Below are 6 screens from the ClinPlus DM system, a SAS-based solution that has been used since 1996 by over 60 biopharmaceutical organizations worldwide.  1. Data Entry ScreensData entry screens are designed in our screen design module and can include […]

Exporting SAS data files across environments in clinical trials

One of our biopharm clients that uses our clinical data management software, recently tried to share SAS data files with the biostats department…a pretty common requirement these days. When the biostatistician tried opening the file, they received the following error: Error when trying to read the file: ERROR: Invalid or missing READ password on member […]

Clinical Data Management Models in CDISC

Clinical Data Interchange Standards Consortium (CDISC) The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit group that defines clinical data standards for the pharmaceutical industry. CDISC has developed numerous data models that you should familiarize yourself with. Four of these models are of particular importance:  Study Data Tabulation Model (SDTM). The SDTM defines the […]