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Electronic common technical document
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121	APPENDIX A: eCTD Q&A or Change Request This form should be used to request a change to the ICH eCTD Specification. The change can be to fix a perceived “bug”, meet a new requirement or to enhance existing functiona Add to Reading List Source URL: estri.ich.org Language: English - Date: 2015-02-12 20:10:15 Research Electronic Common Technical Document Technology Evaluation Specification Requirement Clinical research Clinical Data Management Medical informatics
122	Next Generation of Regulatory Information Management New! Add to Reading List Source URL: www.eracon.org Language: English - Date: 2015-04-23 05:33:12 Clinical Data Management Medical informatics Electronic Common Technical Document Submission management Regulatory affairs Food and Drug Administration EMC Corporation Research Medicine Clinical research
123	INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE M2 Glossary of Terms and Abbreviations 2 June 2014 Add to Reading List Source URL: estri.org Language: English - Date: 2014-06-13 11:33:23 Pharmaceutical industry Medicine Medical informatics Clinical Data Management Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document IFPMA MedDRA Clinical research Research Health
124	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.ich.org Language: English - Date: 2015-02-12 20:10:35 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
125	The eCTD Backbone Files Specification for Study Tagging Files Add to Reading List Source URL: estri.ich.org Language: English - Date: 2012-06-04 19:13:02 Clinical Data Management Medical informatics Electronic Common Technical Document Markup languages Technical communication Document Type Definition HTML element XML Attribute Computing Clinical research Research
126	EWG M2 Recommendation to the ICH Steering Committee Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF/A 2 June 2014 _______________________________________________ Add to Reading List Source URL: estri.ich.org Language: English - Date: 2014-06-13 05:26:26 Computer graphics Reference Adobe Systems Computer file formats Clinical research Electronic Common Technical Document Portable Document Format PDF/A Open standard ISO standards Computing Graphics file formats
127	APPENDIX A: eCTD Q&A or Change Request This form should be used to request a change to the ICH eCTD Specification. The change can be to fix a perceived “bug”, meet a new requirement or to enhance existing functiona Add to Reading List Source URL: estri.org Language: English - Date: 2012-06-05 01:13:00 Research Electronic Common Technical Document Technology Evaluation Specification Requirement Clinical research Clinical Data Management Medical informatics
128	Recommendation Notebook Version 3.0 ICH M2 Electronic Standards for the Transfer of Regulatory Information Add to Reading List Source URL: estri.org Language: English - Date: 2012-06-05 01:13:02 Environmental Working Group Food and Drug Administration International standard Electronic Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical research Research Pharmaceutical sciences
129	Microsoft Word - File Security - MD5 v1_0-hwm.doc Add to Reading List Source URL: estri.org Language: English - Date: 2012-06-05 01:13:02 Checksum Electronic Common Technical Document MD5 Cryptographic hash function Cksum Sum Simple file verification Computing Software Unix
130	The eCTD Backbone Files Specification for Study Tagging Files Add to Reading List Source URL: estri.org Language: English - Date: 2012-06-05 01:13:02 Clinical Data Management Medical informatics Electronic Common Technical Document Markup languages Technical communication Document Type Definition HTML element XML Attribute Computing Clinical research Research

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