Dictionary of Evidence-based Medicine.pdf
Dictionary of Evidence-based Medicine.pdf
Dictionary of Evidence-based Medicine.pdf
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I<br />
ICD (see International Classification <strong>of</strong> Diseases)<br />
ICD-9-CM<br />
ICD-9-CM is a classification <strong>of</strong> medical procedures <strong>based</strong> on the ninth<br />
revision <strong>of</strong> the International Classification <strong>of</strong> Diseases published by the World<br />
Health Organization. The hierarchical classification uses up to four digits<br />
to classify a particular procedure. For example, all operations on the cardiovascular<br />
system are coded with a first digit 3. Operations on the valves<br />
and septa <strong>of</strong> the heart are given a code <strong>of</strong> 35. Closed heart valvotomy,<br />
which is in the next hierarchical level, is given the code 35.0 and closed<br />
heart valvotomy involving the mitral valve 35.02 (ICD-9-CM. International<br />
classification <strong>of</strong> diseases (9th revision) (1994) Clinical modification. 4th<br />
edition. US Dept <strong>of</strong> Health and Human Services, Washington DC).<br />
ICH<br />
The International Conferences on Harmonization (ICH) are a series <strong>of</strong><br />
conferences organized by the drug regulatory agencies <strong>of</strong> the USA, the<br />
European Community and Japan to develop consensus positions about<br />
various technical requirements for registration <strong>of</strong> pharmaceuticals for<br />
human use. Examples <strong>of</strong> issues considered include genotoxicity tests for<br />
pharmaceuticals, structure and content <strong>of</strong> clinical study reports and carcinogenicity<br />
studies <strong>of</strong> pharmaceuticals. Expert working parties are set up<br />
to draft guidelines (grey report, stage 2 <strong>of</strong> the ICH process) which are<br />
issued to various interested parties, notably the pharmaceutical industry,<br />
for comment. The comments are considered and ICH harmonized tripartite<br />
guidelines agreed on at steering committee meetings held in one <strong>of</strong> the<br />
three regions. Those guidelines (yellow reports, stage 4 <strong>of</strong> the ICH process)<br />
are issued with the recommendation that they be adopted by the three<br />
regulatory parties. Further information may be obtained from the secretariat:<br />
IFPMA, 30 Rue de St Jean, PO Box 9, 1211 Geneva 18, Switzerland.<br />
Fax +41-223458275.