The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory...
14 KB (1,344 words) - 20:42, 29 May 2025
CTDs are destined for replacement by their electronic counterparts, the eCTDs. The Common Technical Document is divided into five modules: Administrative...
5 KB (412 words) - 20:25, 29 May 2025
exporting country; it is often mentioned in conjunction with the electronic Common Technical Document (eCTD). A CPP is issued for a single product, because manufacturing...
8 KB (946 words) - 20:19, 29 May 2025
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. "ICH M2 EWG - Electronic Common Technical Document Specification"...
38 KB (4,115 words) - 04:37, 4 June 2025
for the Common Technical Document (CTD) format, and more recently,[when?] its electronic version – the electronic Common Technical Document (eCTD). The...
6 KB (871 words) - 17:55, 30 June 2024
management, document imaging, workflow systems and records management systems. While many electronic document management systems store documents in their...
28 KB (1,550 words) - 20:37, 29 May 2025
Clinical trial management system Clinical trial Electronic data capture Electronic Common Technical Document (eCTD) Drug development "Docterz-Technology made...
7 KB (979 words) - 16:58, 18 August 2022
1–95. Retrieved 2025-02-25. This document describes handling of Appendix 3 "ICH electronic common technical document (eCTD) v4.0 Implementation guide...
6 KB (564 words) - 14:35, 16 March 2025
through an electronic billing system. The printed transaction documents, once delivered to the post office, conform to the mail box rule. Common examples...
1 KB (144 words) - 16:08, 28 June 2025
valid document. These common criticisms were considered in the development of the new Italian electronic identity card, which is in the more common credit-card...
194 KB (23,071 words) - 06:28, 27 June 2025
trials publication Common Technical Document Consolidated Standards of Reporting Trials (CONSORT) Electronic Common Technical Document Preferred Reporting...
13 KB (1,428 words) - 23:24, 2 November 2024
Data Monitoring Committees Drug development Drug recall Electronic Common Technical Document Ethical problems using children in clinical trials EudraCT...
19 KB (1,864 words) - 14:14, 23 October 2024
implement electronic signatures. While an electronic signature can be as simple as a name entered in an electronic document, digital signatures are increasingly...
45 KB (4,355 words) - 08:11, 24 May 2025
Data definition specification (category Wikipedia articles that are too technical from December 2012)
the 1999 FDA electronic submission (eSub) guidance and electronic Common Technical Document (eCTD) documents specifying that a document describing the...
9 KB (1,112 words) - 16:48, 16 July 2023
Clinical Data Interchange Standards Consortium (category Standards for electronic health records)
Clinical trial Data model Data warehouse DICOM Electronic Common Technical Document (eCTD) Electronic data capture Health Informatics Service Architecture...
14 KB (1,626 words) - 03:41, 21 January 2025
an electronic form may be subject to production under common eDiscovery rules. This type of data has historically included email and office documents (spreadsheets...
29 KB (3,539 words) - 15:00, 29 January 2025
Submission management (section Common scenarios)
ICH has developed the electronic Common Technical Document (eCTD) to promote harmonization of regulatory submissions in electronic format across various...
10 KB (1,290 words) - 09:32, 1 July 2025
himself. PDF was one of a number of competing electronic document formats in that era such as DjVu, Envoy, Common Ground Digital Paper, Farallon Replica and...
35 KB (2,980 words) - 07:59, 30 October 2024
Interleaf (category Technical communication tools)
products for the technical publishing creation and distribution process. Founded in 1981, its initial product was the first commercial document processor that...
16 KB (1,829 words) - 20:09, 26 May 2025
select group of readers. Technical writers research and create information through a variety of delivery media (electronic, printed, audio-visual, and...
35 KB (4,271 words) - 07:14, 28 June 2025
Machine-readable passport (redirect from Machine Readable Travel Document)
the second row is: The ICAO document 9303 part 3 describes specifications common to all Machine Readable Travel Documents. The dimensions of the effective...
21 KB (2,084 words) - 00:57, 16 May 2025
their technical position (e.g., engineers). In either case, these individuals utilize appropriate skills to research, document, and present technical information...
20 KB (2,431 words) - 03:37, 2 June 2025
abstractions representing idealized electronic components and elements. A datasheet for an electronic component is a technical document that provides detailed information...
26 KB (2,806 words) - 10:40, 2 July 2025
associated with electronic publishing, there are many non-network electronic publications such as encyclopedias on CD and DVD, as well as technical and reference...
22 KB (2,564 words) - 16:54, 29 May 2025
A Common Source Database (CSDB) is to provide the user (mainly technical authors, illustrators, and publication managers) with automated processes to handle...
6 KB (782 words) - 20:24, 3 November 2024
committee conceptual document from 2007, MCM_0142 Nov 2007 Military Committee Transformation Concept for Future NATO Electronic Warfare,[citation needed]...
36 KB (3,701 words) - 00:31, 20 June 2025
initiative started to standardize the electronic exchange of product data for technical products, to enable the electronic trading of these products. Over time...
4 KB (551 words) - 09:32, 31 January 2025
for precise communication in the preparation of a functional document distinguishes technical drawing from the expressive drawing of the visual arts. Artistic...
25 KB (3,111 words) - 20:23, 23 June 2025
EDAPS (section INTERPOL electronic documents)
engraving and electronic personalization of ID-documents. November, 2010 - The EDAPS Consortium was selected as the manufacturer for electronic boimetric...
11 KB (1,001 words) - 19:18, 23 December 2024
A technical report (also scientific report) is a document that describes the process, progress, or results of technical or scientific research or the...
8 KB (945 words) - 22:14, 2 June 2025