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Clinical Data Management
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231	PDF Document Add to Reading List Source URL: ctc.usyd.edu.au Language: English - Date: 2013-05-19 19:56:29 Password Pharmaceutical industry Science Case report form Clinical trial CTC Research Clinical research Clinical Data Management
232	Future direction: CDISC - an integrated part of eCTD May 2015 aCROnordic - CDISC Legacy Data Conversion Services Add to Reading List Source URL: acronordic.azurewebsites.net Language: English - Date: 2015-05-03 09:12:37 Medical informatics Clinical Data Management Food and Drug Administration Standards organizations Clinical Data Interchange Standards Consortium Prescription Drug User Fee Act Electronic Common Technical Document Clinical trial Research Clinical research Health
233	ICH eCTD Specification Change Control V1.8 ICH eCTD Specification Change Control V1.8 ICH eCTD Specification Change Control V1.8 ICH eCTD Specification Change Control V1.8 ICH eCTD Specification Change Control V1.8 ICH e Add to Reading List Source URL: estri.org Language: English - Date: 2012-06-05 01:13:00 Drug safety Standards Medical informatics Electronic Common Technical Document Medicine Technology International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Change control Specification Clinical research Research Clinical Data Management
234	DANA-FARBER / HARVARD CANCER CENTER STANDARD OPERATING PROCEDURES FOR HUMAN SUBJECT RESEARCH TITLE: Source Documentation Requirements SOP #: DOC-101 (formerly PM-417) Page: 1 of 7 Add to Reading List Source URL: www.dfhcc.harvard.edu Language: English - Date: 2014-09-18 14:55:03 Science Pharmaceutical industry Medicine Pharmacology Information science Case report form Institutional review board Dana–Farber Cancer Institute Documentation Clinical research Research Clinical Data Management
235	Requirements on Submissions (number and format) for New Applications within MRP, DCP and National Procedures Doc. Ref.: CMDhRev.16 AprilNew submissions should generally be submitted in eCTD format (highl Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-04-29 10:02:08 Clinical Data Management Clinical research Electronic Common Technical Document
236	Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures Doc. Ref.: CMDhRev.14 AprilSubmissions should generally be submitted in eCTD format (highly Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-04-29 10:02:09 Electronic signage Clinical Data Management Clinical research Electronic Common Technical Document
237	Journal of Orthopaedic Surgery and Research BioMed Central Open Access Add to Reading List Source URL: www.josr-online.com Language: English Statistics Implants Orthopedic surgery Prosthetics Clinical Data Management Quality of life SF-36 WOMAC Cohort study Medicine Health Psychometrics
238	DANA-FARBER / HARVARD CANCER CENTER STANDARD OPERATING PROCEDURES FOR HUMAN SUBJECT RESEARCH TITLE Case Report Form (CRF) Design for PI-Initiated Protocols SOP #: DATA-101 (formerly QA-715) Page: 1 of 6 Add to Reading List Source URL: www.dfhcc.harvard.edu Language: English - Date: 2014-02-20 14:53:05 Medicine Pharmaceutical industry Clinical Data Management Design of experiments Pharmacology Case report form Dana–Farber Cancer Institute Investigational Device Exemption Clinical trial Clinical research Research Science
239	eAF-Release-Notes-MAAH_1 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2015-05-07 06:59:19 Electronic Common Technical Document HTML element Portable Document Format DETAIL Computing Clinical Data Management Clinical research
240	EX_Fly-Prod_EURS_2014.indd Add to Reading List Source URL: www.extedo.com Language: English - Date: 2014-09-02 09:07:25 Pharmaceutical sciences Knowledge Clinical Data Management Validity Quality Electronic Common Technical Document Submission management Validation Pharmacovigilance Clinical research Pharmaceutical industry Research

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