Good Clinical Data Management Practice

Results: 43



#Item
11Clinical 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
12Clinical Data Management / Health / Cancer organizations / Pharmaceutical industry / Clinical trial / Case report form / Good Clinical Practice / Audit / Eastern Cooperative Oncology Group / Medicine / Research / Clinical research

2012 CTMB Audit Guidelines

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Source URL: ctep.cancer.gov

Language: English - Date: 2014-04-03 21:03:34
13Pharmaceutical industry / Pharmacology / Food and Drug Administration / Clinical trial / Clinical investigator / Regulatory requirement / Good Clinical Practice / Center for Drug Evaluation and Research / Good Clinical Data Management Practice / Clinical research / Research / Pharmaceutical sciences

Oversight of Clinical Investigations:  A Risk­Based Approach to Monitoring  (Draft Guidance) U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluatio

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Source URL: www.fda.gov.

Language: English
14Food and drink / Center for Devices and Radiological Health / Center for Food Safety and Applied Nutrition / Center for Drug Evaluation and Research / Title 21 of the Code of Federal Regulations / Center for Biologics Evaluation and Research / Center for Veterinary Medicine / Federal Food /  Drug /  and Cosmetic Act / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

SMG[removed]FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY ISSUANCE OF REPORTS OF MINOR VIOLATIONS Effective Date: June 4, 2010

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Source URL: www.fda.gov

Language: English
15Pharmaceutical sciences / Pharmaceutics / Medical statistics / Evaluation methods / Pharmacology / Clinical trial / Good Clinical Practice / Clinical data management / Doctor of Pharmacy / Clinical research / Pharmaceutical industry / Research

SF STATE Extended Learning[removed]PROFESSIONAL DEVELOPMENT PROGRAM

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Source URL: www.cel.sfsu.edu

Language: English - Date: 2013-07-24 17:38:00
16Pharmaceutical industry / Medicine / Nursing research / Clinical trial / National Institute of Allergy and Infectious Diseases / Case report form / National Institutes of Health / Good Clinical Practice / Research / Clinical Data Management / Clinical research

Policy: Requirements for Data Management and Statistics for DAIDS Funded and/or Sponsored Clinical Trials

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Source URL: www.niaid.nih.gov

Language: English - Date: 2012-11-13 15:43:24
17Health / Nursing research / Pharmaceutical industry / Clinical Data Management / National Institutes of Health / National Institute of Allergy and Infectious Diseases / Clinical trial / Good Clinical Practice / Clinical Data Interchange Standards Consortium / Research / Clinical research / Medicine

Expanded distribution of clinical research endpoint data

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Source URL: www.niaid.nih.gov

Language: English - Date: 2013-04-26 13:28:48
18Medicine / Pharmaceutical industry / Nursing research / National Institute of Allergy and Infectious Diseases / National Institutes of Health / Clinical trial / Good Clinical Practice / Case report form / Food and Drug Administration / Research / Clinical research / Clinical Data Management

NIAID Clinical Research Standards FINAL VERSION 3.0 August 6, 2013 NIAID CLINICAL RESEARCH STANDARDS The NIAID Clinical Research Standards provide a framework to promote scientifically

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Source URL: www.niaid.nih.gov

Language: English - Date: 2013-09-09 10:53:15
19Pharmaceutical sciences / Science / Clinical Data Management / Clinical trial / Pharmacology / Case report form / Deutscher Wetterdienst / Pharmacist / Good Clinical Practice / Pharmaceutical industry / Clinical research / Research

Appendix 2: Manual of Operations (MOP) Sample Table of Contents

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Source URL: www.niaid.nih.gov

Language: English - Date: 2013-05-28 14:29:56
20Clinical research / Clinical pharmacology / Pharmacology / Therapeutics / United States Public Health Service / Center for Food Safety and Applied Nutrition / Center for Drug Evaluation and Research / Good Clinical Data Management Practice / Food and Drug Administration / Health / Pharmaceutical sciences

SMG[removed]FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY CERTIFICATION OF TRUE COPIES AND USE OF DEPARTMENT SEAL Effective Date: [removed]

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Source URL: www.fda.gov

Language: English
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