Difference between revisions of "RPS Glossary"

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[[Category:RCRIM]]
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[[Category:RPS]]
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[[Main Page]] | [[Regulated Clinical Research Information Management]] | [[Regulated Product Submissions]] | RPS Glossary
 
[[Main Page]] | [[Regulated Clinical Research Information Management]] | [[Regulated Product Submissions]] | RPS Glossary
  
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*[[Approval Unit (RPS)|Approval Unit]]
 
*[[Approval Unit (RPS)|Approval Unit]]
 
*[[Board of Health]] ([[BoH]])
 
*[[Board of Health]] ([[BoH]])
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*[[RPS Hyperlinking|Broken Links]] ([[RPS Hyperlinking]])
 
*[[Chemistry, Manufacturing and Controls]] ([[CMC]])
 
*[[Chemistry, Manufacturing and Controls]] ([[CMC]])
 
*[[Center for Devices and Radiological Health]] ([[CDRH]]) (FDA)
 
*[[Center for Devices and Radiological Health]] ([[CDRH]]) (FDA)
 
*[[Center for Food Safety and Applied Nutrition]] ([[CFSAN]]) (FDA)
 
*[[Center for Food Safety and Applied Nutrition]] ([[CFSAN]]) (FDA)
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*[[Contact Type (RPS)|Contact Type]]
 
*[[Context of Use (RPS)|Context of Use]]
 
*[[Context of Use (RPS)|Context of Use]]
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*[[Correspondence (RPS)|Correspondence]]
 
*[[Document (RPS)|Document]]
 
*[[Document (RPS)|Document]]
 
*[[Document Reference (RPS)|Document Reference]]
 
*[[Document Reference (RPS)|Document Reference]]
 
*[[Document Relationship (RPS)|Document Relationship]]
 
*[[Document Relationship (RPS)|Document Relationship]]
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*[[Dossier]] - Generalized synonym for RPS [[Application (RPS)|Application]] concept
 
*[[Drug Master File]] ([[DMF]])
 
*[[Drug Master File]] ([[DMF]])
 
*[[Electrocardiogram]] ([[ECG]])
 
*[[Electrocardiogram]] ([[ECG]])
 
*[[European Union]] ([[EU]])
 
*[[European Union]] ([[EU]])
 
*[[External Electronic Source (RPS)|External Electronic Source]] / non-retrievable
 
*[[External Electronic Source (RPS)|External Electronic Source]] / non-retrievable
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*[[File (RPS)|File]]
 
*[[Food and Drug Administration]] ([[FDA]]) (US)
 
*[[Food and Drug Administration]] ([[FDA]]) (US)
 
*[[Holder of Reference Master File]]
 
*[[Holder of Reference Master File]]
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*[[RPS Hyperlinking|Hyperlinking]]
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*[[International Conference on Harmonisation]] ([[ICH]])
 
*[[Investigational New Drug]] ([[IND]])
 
*[[Investigational New Drug]] ([[IND]])
 
*[[Investigator Brochure]] ([[IB]])
 
*[[Investigator Brochure]] ([[IB]])
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*[[Master File Holder]]
 
*[[Master File Holder]]
 
*[[Member State]]
 
*[[Member State]]
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*[[Message (RPS)|Message]]
 
*[[New Drug Application]] ([[NDA]])
 
*[[New Drug Application]] ([[NDA]])
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*[[Package (RPS)|Package]] - Generalized synonym for RPS [[Submission Unit (RPS)|Submission Unit]] concept
 
*[[Periodic Safety Update Report]] ([[PSUR]])
 
*[[Periodic Safety Update Report]] ([[PSUR]])
 
*[[Phase I Meeting]]
 
*[[Phase I Meeting]]
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*[[Post-market]]
 
*[[Post-market]]
 
*[[Pre-submission]]
 
*[[Pre-submission]]
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*[[Product (RPS)|Product]]
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*[[Regulated Industry]]
 
*[[Regulated Product (RPS)|Regulated Product]]
 
*[[Regulated Product (RPS)|Regulated Product]]
*[[Regulated Product Submission]] (RPS)
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*[[Regulated Product Submissions]] (RPS)
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*[[Regulatory Activity]] -- Generalized synonym for RPS [[Submission (RPS)|Submission]]
 
*[[Regulatory Authority (RPS)|Regulatory Authority]]
 
*[[Regulatory Authority (RPS)|Regulatory Authority]]
 
*[[Reviewable Unit (RPS)|Reviewable Unit]]
 
*[[Reviewable Unit (RPS)|Reviewable Unit]]
 
*[[Right of Reference Request]]
 
*[[Right of Reference Request]]
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*[[Sponsor (RPS)|Sponsor]]
 
*[[Submission (RPS)|Submission]]
 
*[[Submission (RPS)|Submission]]
 
*[[Submission Unit (RPS)|Submission Unit]]
 
*[[Submission Unit (RPS)|Submission Unit]]
*[[Sponsor (RPS)|Sponsor]]
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*[[Submission Unit Type (RPS)|Submission Unit Type]]
 
*[[Supplemental New Drug Application]] ([[sNDA]])
 
*[[Supplemental New Drug Application]] ([[sNDA]])
 
*[[Table of Contents]] ([[TOC]])
 
*[[Table of Contents]] ([[TOC]])
*[[Threaded Discussion (RPS)|Threaded Discussion]]
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*[[RPS Threaded Discussions|Threaded Discussions]]

Latest revision as of 14:51, 25 August 2010


Main Page | Regulated Clinical Research Information Management | Regulated Product Submissions | RPS Glossary

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Please see the RPS Glossary Documentation page for instructions for creating and editing entries.

Glossary of Abbreviations and Terms