Slide Decks

Below are a collection of slide decks that provide further insight into standards, DLPs, and other aspects of Kestrel’s work. Following that are some useful web links.

DLPs the Concept (Size 675k)

This slide deck provides a high level view of the approach that DLPs take to standardization. It lays out the common current practices, and shows how, by approaching the process a bit differently, DLPs can help organizations achieve far greater results from their standards initiatives.

DLPs the Structure (Size 486k)

Addressing each component in turn, this presentation shows how the different parts of the DLP fit together, and the content that each component contains. It runs the gamut from protocol wording to database structure to analysis plan, etc.

Gotcha! GCP Audits and Preventing the Pain (Size 775k)

Presented at the 2007 Clinical Research Education Conference hosted by Northwestern University. Approached from the investigative's site point of view, this presentation covers some of the most common regulatory inspection findings, provides insights into why they are issues, and suggests ways to avod the problems.

The Landscape of Standards (Size 681k)

Originally presented at the 2008 DIA Clinical Data Management Meeting. There are many standards and standards organizations that either impact clinical trials today or are likely to in the near future. Using the CDISC organization as a focal point, this presentation describes 15 standards organizations and over 2 dozen standards ech in relation to the others as they affect clinical research.

Demystifying 21CRF11 NCCR (Size 99k)

Originally presented at the 2005 Northwestern Clinical Research Education Conference, this presentation reviews the basic concepts contained in the regulation and outlines what impact it may have on academic clinical research centers.

Operationalizing the Study (Size 303k)

Geared toward the independent or academic clinical researcher, this slide deck raises awareness of the importance the data collection, handling and analysis aspects of a protocol. It also provides tips on how to approach the process.