Difference between revisions of "RPS Glossary"

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(New page: Main Page | Regulated Clinical Research Information Management | Regulated Product Submissions | RPS Glossary == Glossary of Abbreviations and Terms == ''This article is under ...)
 
 
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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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''This article is under construction''
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Please see the [[RPS Glossary/doc|RPS Glossary Documentation]] page for instructions for creating and editing entries.
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== Glossary of Abbreviations and Terms ==
 
== Glossary of Abbreviations and Terms ==
''This article is under construction''
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*[[Abbreviated New Drug Application]] ([[ANDA]])
*Abbreviated New Drug Application (ANDA)
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*[[Annotated ECG]] ([[aECG]])
*Annotated ECG (aECG)
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*[[Application (RPS)|Application]]
*Application
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*[[Application Number]]
*Application Number  
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*[[Approval (RPS)|Approval]]
*Board of Health (BoH)
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*[[Approval Unit (RPS)|Approval Unit]]
*Chemistry, Manufacturing and Controls (CMC)
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*[[Board of Health]] ([[BoH]])
*Center for Devices and Radiological Health (CDRH) (FDA)
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*[[RPS Hyperlinking|Broken Links]] ([[RPS Hyperlinking]])
*Center for Food Safety and Applied Nutrition (CFSAN) (FDA)
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*[[Chemistry, Manufacturing and Controls]] ([[CMC]])
*Context of Use
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*[[Center for Devices and Radiological Health]] ([[CDRH]]) (FDA)
*Drug Master File (DMF)
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*[[Center for Food Safety and Applied Nutrition]] ([[CFSAN]]) (FDA)
*Electrocardiogram (ECG)
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*[[Contact Type (RPS)|Contact Type]]
*European Union (EU)
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*[[Context of Use (RPS)|Context of Use]]
*external electronic source / non-retrievable
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*[[Correspondence (RPS)|Correspondence]]
*Food and Drug Administration (FDA) (US)
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*[[Document (RPS)|Document]]
*Holder of Reference Master File
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*[[Document Reference (RPS)|Document Reference]]
*Investigational New Drug (IND)
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*[[Document Relationship (RPS)|Document Relationship]]
*Investigator Brochure (IB)
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*[[Dossier]] - Generalized synonym for RPS [[Application (RPS)|Application]] concept
*Keyword
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*[[Drug Master File]] ([[DMF]])
*Master Access File
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*[[Electrocardiogram]] ([[ECG]])
*Master File Holder
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*[[European Union]] ([[EU]])
*Member State
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*[[External Electronic Source (RPS)|External Electronic Source]] / non-retrievable
*New Drug Application (NDA)
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*[[File (RPS)|File]]
*Periodic Safety Update Report (PSUR)
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*[[Food and Drug Administration]] ([[FDA]]) (US)
*Phase I Meeting
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*[[Holder of Reference Master File]]
*Phase II Meeting
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*[[RPS Hyperlinking|Hyperlinking]]
*Post-market
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*[[International Conference on Harmonisation]] ([[ICH]])
*Pre-submission
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*[[Investigational New Drug]] ([[IND]])
*[[Regulated Product Submission]] (RPS)
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*[[Investigator Brochure]] ([[IB]])
*Right of Reference Request
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*[[Keyword (RPS)|Keyword]]
*Submission
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*[[Master Access File]]
*Submission Unit
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*[[Master File Holder]]
*Supplemental New Drug Application (sNDA)
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*[[Member State]]
*Table of Contents (TOC)
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*[[Message (RPS)|Message]]
*Threaded Discussion
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*[[New Drug Application]] ([[NDA]])
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*[[Package (RPS)|Package]] - Generalized synonym for RPS [[Submission Unit (RPS)|Submission Unit]] concept
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*[[Periodic Safety Update Report]] ([[PSUR]])
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*[[Phase I Meeting]]
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*[[Phase II Meeting]]
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*[[Post-market]]
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*[[Pre-submission]]
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*[[Product (RPS)|Product]]
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*[[Regulated Industry]]
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*[[Regulated Product (RPS)|Regulated Product]]
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*[[Regulated Product Submissions]] (RPS)
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*[[Regulatory Activity]] -- Generalized synonym for RPS [[Submission (RPS)|Submission]]
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*[[Regulatory Authority (RPS)|Regulatory Authority]]
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*[[Reviewable Unit (RPS)|Reviewable Unit]]
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*[[Right of Reference Request]]
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*[[Sponsor (RPS)|Sponsor]]
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*[[Submission (RPS)|Submission]]
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*[[Submission Unit (RPS)|Submission Unit]]
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*[[Submission Unit Type (RPS)|Submission Unit Type]]
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*[[Supplemental New Drug Application]] ([[sNDA]])
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*[[Table of Contents]] ([[TOC]])
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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

This article is under construction

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

Glossary of Abbreviations and Terms