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Common Technical Document
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#	Item
471	Microsoft Word - E3 Q&As_R1_ Step4.docx Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-07-17 04:51:43 Scientific method Electronic Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical trial Adverse event Common Technical Document Institutional review board Electronic Entertainment Expo Communications protocol Clinical research Research Science
472	Notice- Electronic Templates for the Quality Information of Drug Submissions for Biological Products and Radiopharmaceuticals Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-12 14:26:55 Application software Clinical Data Management Pharmacology Health Canada Health Products and Food Branch Common Technical Document Biologic WordPerfect Template Software Computing Word processors
473	Microsoft PowerPoint - 250_SHAW.ppt [Compatibility Mode] Add to Reading List Source URL: www.fda.gov Language: English Health Clinical Data Management Clinical research Standards organizations Electronic Common Technical Document Clinical Data Interchange Standards Consortium Health Level 7 Structured Product Labeling Loadable kernel module Medical informatics Spaceflight Medicine
474	Microsoft Word - noc_pn_leviii_notice_form_ac_sa_niviii_avis-eng..doc Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2014-05-01 11:17:59 Clinical research Medical informatics Electronic Common Technical Document Pharmacology Drug Identification Number Common Technical Document Health Canada Clinical Data Management Medicine Research
475	GDUFA Information Technology Plan (Draft) FY[removed]FY 2017 Add to Reading List Source URL: www.fda.gov Language: English Research Medical informatics Clinical research Drug safety Clinical Data Management Electronic Common Technical Document Investigational New Drug New Drug Application Common Technical Document Medicine Health Food and Drug Administration
476	Microsoft Word - E3 Q&As Final Concept Paper 15 June 2011.docx Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:07:57 Medicine Medical informatics Electronic Common Technical Document Common Technical Document Pharmaceutical industry E3 Clinical Data Interchange Standards Consortium Clinical trial Electronic Entertainment Expo Clinical research Clinical Data Management Research
477	November[removed]ICH Procedures Version 1.1 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-03-13 04:57:18 Pharmaceutical sciences Pharmaceutics Clinical Data Management Pharmaceuticals policy Drug safety International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use MedDRA Standard operating procedure Electronic Common Technical Document Clinical research Research Pharmaceutical industry
478	2012 Data Standards Program Annual Assessment Add to Reading List Source URL: www.fda.gov Language: English Health Medicine Clinical Data Management Standards organizations Food and Drug Administration Clinical Data Interchange Standards Consortium Electronic Common Technical Document Health Level 7 SDTM Research Medical informatics Clinical research
479	Notice - Electronic Specifications for Clinical Trial Applications and Amendments Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:52:37 Computing Electronic Common Technical Document Food and Drug Administration Pharmaceutical industry Common Technical Document Clinical trial Computer file Portable Document Format Clinical research Research Clinical Data Management
480	Notice: Release of Health Canada’s Revisions to“1.6 Electronic Review Documents” in Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format. Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-12 14:25:53 Research Medical informatics Electronic documents Electronic Common Technical Document Digital media Common Technical Document Electronic submission Portable Document Format Submission management Clinical Data Management Clinical research Computing

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