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Coding Systems

Clinical Research Terminology (CRT) Codes v1.13 October 1, 2006
This Directory details over 200 investigative site research activities that do not have CPT codes. It is intended to become an industry-standard supplement to CPT codes for understanding and communicating investigative site research activities. Please send suggestions for additions, modifications, clarifications and deletions to the Editor. Future versions of the Directory will be posted on this web page. See article about CRT codes.

Protocol Deviation & Violation (PDV) Codes v1.2 December 11, 2005
The only clear consensus on the definitions of deviations and violations is that a deviation is a small violation and a violation is a big deviation. More precise definitions quickly degrade into guidelines with many gray areas. Protocol Deviation & Violation (PDV) codes solve this problem by just listing them out. Scenarios, where necessary, differentiate between the classifications. This Directory details about 120 circumstances that may constitute a protocol deviation or violation, or just require a progress note. If regulatory authorities, sponsors and IRBs create their own classifications, they can use PDV codes to communicate their special rules without confusion. Perhaps even more importantly, a proper coding system gives us the ability to identify trouble spots, measure trends, and manage down the number of deviations and violations. PDV codes also provide a foundation for training study personnel in GCP. Investigators and study coordinators can learn what NOT to do, and how to handle problems when they do arise. Please send suggestions for additions, modifications, clarifications and deletions to the Editor. Future versions of the Directory will be posted on this web page. See article about PDV codes.

Clinical Research Assessment (CRA) Codes v1.0 February 20, 2005
This Directory details 141 clinical research assessments that do not have CPT codes. It is intended to become an industry-standard supplement to CPT codes for understanding and communicating clinical research assessment activities. There are over 1,000 Quality-of-Life, Patient-Reported-Outcome, and other assessments that could be used in a clinical trial and that do not have CPT codes, so this coding system needs a lot of work. The most complete listing is at http://www.proqolid.org/. Most of these tests already have acronyms, so those are used instead of numerical codes. Please send suggestions for additions, modifications, clarifications and deletions to the Editor. Future versions of the Directory will be posted on this web page.

Clinical Research Service (CRS) Codes v1.0 February 20, 2005
This Directory details about 150 contract research organization (CRO) activities. It is intended to become an industry standard used in CRO RFPs and billing. Please send suggestions for additions, modifications, clarifications and deletions to the Editor. Future versions of the Directory will be posted on this web page.

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