Good Clinical Data Management Practice

Results: 43



#Item
31Research / Center for Biologics Evaluation and Research / New Drug Application / Investigational New Drug / Clinical trial / Center for Drug Evaluation and Research / ClinicalTrials.gov / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

[removed]Federal Register / Vol. 68, No[removed]Monday, August 25, [removed]Notices Washigton, DC 20447, Attn: ACF Reports Clearance Officer. E-mail

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Source URL: www.fda.gov

Language: English - Date: 2003-08-25 06:14:09
32Clinical research / Drug discovery / Pharmacy / Clinical Data Management / Common Technical Document / Clinical pharmacology / Safety pharmacology / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Nonclinical studies / Pharmacology / Pharmaceutical sciences / Research

GUIDELINE FOR GOOD CLINICAL PRACTICE

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:07:25
33Clinical research / Center for Food Safety and Applied Nutrition / Center for Biologics Evaluation and Research / Center for Devices and Radiological Health / FDA Warning Letter / Center for Drug Evaluation and Research / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

FDA Enforcement Statistics Summary

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Source URL: www.fda.gov

Language: English
34Clinical research / Center for Food Safety and Applied Nutrition / Center for Biologics Evaluation and Research / Center for Devices and Radiological Health / FDA Warning Letter / Center for Drug Evaluation and Research / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

FDA Enforcement Statistics Summary Fiscal Year 2010

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Source URL: www.fda.gov

Language: English
35Clinical research / Center for Biologics Evaluation and Research / Office of Regulatory Affairs / Center for Drug Evaluation and Research / Abbreviated New Drug Application / Center for Veterinary Medicine / Structured Product Labeling / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

Microsoft Word - 11121dft[removed]doc

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Source URL: www.fda.gov

Language: English
36Food and Drug Administration / Pharmacology / Clinical Data Management / Common Technical Document / Center for Biologics Evaluation and Research / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Center for Drug Evaluation and Research / Good Laboratory Practice / Biologic / Clinical research / Research / Medicine

Guidance for Industry M4: The CTD - Safety Questions and Answers

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Source URL: www.fda.gov

Language: English
37Pharmaceutical sciences / Structured Product Labeling / Title 21 CFR Part 11 / Title 21 of the Code of Federal Regulations / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / National Drug Code / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

From: Randy Levin, M.D. Associate Director for Medical Informatics Center for Drug Evaluation and Research FDA

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Source URL: www.fda.gov

Language: English
38Science / Electronic Common Technical Document / Common Technical Document / Pharmaceuticals policy / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Clinical trial / HTML element / Documentation / Clinical research / Research / Clinical Data Management

GUIDELINE FOR GOOD CLINICAL PRACTICE

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:07:22
39Pharmaceutical sciences / MedWatch / Medical device / Adverse event / Center for Devices and Radiological Health / Unique Device Identification / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

Medical Device Reporting for User Facilities DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration

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Source URL: www.fda.gov

Language: English
40Pharmaceutics / Pharmaceutical sciences / Clinical Data Management / pharmacology / Good Clinical Practice / Clinical trial / Regulatory requirement / Case report form / Data monitoring committees / Clinical research / Pharmaceutical industry / Research

Joint Research Compliance Office This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled.

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Source URL: workspace.imperial.ac.uk

Language: English - Date: 2012-12-17 09:13:53
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