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Good Clinical Data Management Practice
Results: 43

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1	Data Integrity and Compliance With CGMP Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacology Pharmaceutical sciences Economy Pharmaceuticals policy Clinical data management Code of Federal Regulations Food and Drug Administration Title 21 CFR Part 11 Good manufacturing practice Validation Title 21 of the Code of Federal Regulations
2	p-medicine – Grant Agreement noD2.1 – State of the art review of the p-medicine environment Deliverable No. 2.1 State of the art review of the p-medicine environment Add to Reading List Source URL: p-medicine.eu Language: English - Date: 2013-02-13 06:22:25 Medical research Clinical research Clinical data management Clinical trial management system Clinical trial Clinical data management system Health informatics Clinical Academic clinical trial Electronic data capture Trial master file Good clinical practice
3	GOOD PRACTICE PRINCIPLES FOR SHARING INDIVIDUAL PARTICIPANT DATA FROM PUBLICLY FUNDED CLINICAL TRIALS Add to Reading List Source URL: www.methodologyhubs.mrc.ac.uk Language: English - Date: 2015-07-13 17:43:51 Clinical research Pharmaceutical industry Clinical pharmacology Epidemiology Medical statistics Clinical trial Lesley Stewart Data management plan Data sharing Case report form Individual participant data YODA Project
4	In the Patient’s Interest: Improving Access to Clinical Trial Data August 2014 Prepared by: Brenda J. Huneycutt, PhD, JD, MPH; Add to Reading List Source URL: avalere-health-production.s3.amazonaws.com Language: English - Date: 2014-09-02 10:04:47 Medicine Pharmaceutical industry Design of experiments Epidemiology Medical statistics Clinical trial Randomized controlled trial Good Clinical Practice Clinical data management Clinical research Research Health
5	PRESS RELEASE Lisbon, Portugal, November 2014 The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal, EU on November 8 – 13, 2014. The m Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-12-02 06:07:25 Pharmaceuticals policy Pharmaceutical sciences Health Clinical Data Management Pharmacology International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document Common Technical Document Good Clinical Practice Clinical research Research Pharmaceutical industry
6	Microsoft Word - ctc-effective-design-for-crfs-jun09.doc Add to Reading List Source URL: www.ctc.usyd.edu.au Language: English - Date: 2013-07-25 01:36:54 Pharmaceutical industry Pharmaceutics Evaluation methods Case report form Clinical trial Clinical data acquisition Good Clinical Practice Protocol Medical research Research Clinical Data Management Clinical research
7	Re-inventing clinical trials through TransCelerate Add to Reading List Source URL: www.nature.com Language: English - Date: 2014-10-31 02:12:56 Science Statistics Clinical Data Management Epidemiology Clinical trial Clinical Data Interchange Standards Consortium Good Clinical Practice Clinical site Clinical research coordinator Clinical research Research Pharmaceutical industry
8	Basic Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Clinical research Office of Regulatory Affairs Center for Food Safety and Applied Nutrition Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Biologic ORA Good Clinical Data Management Practice Food and Drug Administration Medicine Health
9	Staff Manual Guide[removed] Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Office of Regulatory Affairs Center for Veterinary Medicine Biologic Regulatory affairs Good Clinical Data Management Practice Food and Drug Administration Medicine Clinical research
10	Medical Device Reporting for User Facilities DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical 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