Module 2 Summaries
The files in this module should be provided as PDF text with the exception of a few embedded images, when needed. The name of the folder for module 2 should be m2. The folders in module 2 should be named as follows.
eCTD Module 1
Module 1
Administrative Information and Prescribing Information
The name of the folder for module 1 should be m1.
This module contains administrative information that is unique for each region. Regional guidance will provide the specific instructions on how to provide the administrative forms and detailed prescribing information.
Country (national or EU / USA / Japan)
- Application number centralised application Number or MRP procedure number
- Calibri;”>Agency-name picklist value in the most recent EU m1 eCTD specification
- Submission type picklist value in the most recent EU m1 eCTD specification
- Procedure type picklist value in the most recent EU m1 eCTD specification
- Invented-name trade name
- INN The International non-Proprietary name for the drug substance
- Sequence The sequence number here must match the sequence number in the folder structure
- Related-sequence
- Submission-description This element is used to describe this particular eCTD sequence
Country In the centralised procedure, there should only be one envelope with the entry ‘emea’. For MRP/DCP, each country in the procedure needs to have a separate envelope entry. Common must not be used as a country identifier in the envelope.
Application number The application number should be the centralised procedure/application number (EMEA/H/C/…), MRP/DCP procedure number (e.g. SE/H/1234…) or other national application or licence number as required by NCAs. Multiple entries are possible. The full application number including the regulatory activity identifier should be used if known.
Applicant Entries for ‘applicant’ should be consistent for all eCTDs from any single applicant (legal entity), as they define where eCTDs are stored in internal systems. Consistency of spelling is also relevant over time to allocate the eCTD correctly.
Agency-name Self explanatory, from picklist in the most recent EU m1 eCTD specification. Assure that Country and Agency name will be consistent.
ATC If unknown at the time of submission, the entry can say ‘to be confirmed’.
Submission type From picklist, see m1 specification for further details.
Procedure type From picklist, see m1 specification for further details.
Invented-name The trade name/invented name for the medicinal product covered by the application. If the eCTD covers multiple strengths or dosage forms, this entry does not need to describe the complete name, a simple entry, for example, ‘Wonderdrug’ will suffice.
INN The International non-Proprietary name for the drug substance.
Sequence The sequence number here must match the sequence number in the folder structure.
Related-sequence For a description and example of how to use the ‘related sequence’ entry
Searchtechnology xPlore
Additional to my study papers a little summary of the next generation full text engine xPlore.
XPlore was released October 2010 for Documentum 6.5 SP2 / 6.5 SP3 / 6.6 and worked in the Dual Mode with the FAST engine. Since Documentum 6.7 and CenterStage 1.1 only xPlore search is available.
FAST vs. xPlore Interface
- Result by xPlore engine. This shot was taken from CenterStage version 1.2
- Search Result with FAST engine. This screenshot was taken from the TaskSpace 6.6 envirnment.
Benefit
- The main benefit is the complete new indexing services based on Lucene of the Apache Software Foundation. Lucene works on the Documentum xDB (XML Database) und using the XQuery Language.
- xPlore provides native support for ACLs. Unauthorized documents are not collected. FAST engine collects all result document and the ContentServer filter the results.
Exam question
Search features: Search ranking compared.
| Webtop | Taskspace | CenterStage |
| procentual | no ranking | up to three bullets |
addition links
Jeetu is Chief Marketing Officer and Chief Strategy Officer for the EMC Information Intelligence Group.
http://blog.pateljeetu.com/2012/02/15/searching-for-a-better-answer-xplore-your-way-through-the-enterprise/
EMC xPlore Questions & Answers (as of summer 2010)
Blog links
Jeroen’s Crazy Content
http://emccrazycontent.com/
Jeroen VanRotterdam, Chief Architect
EMC Information Intelligence Group
Inside Documentum
https://robineast.wordpress.com/
This blog is dedicated to the more technical and esoteric aspects of developing and running Documentum systems.
Ajith Prabhakar’s Weblog
http://ajithp.com/
A beginner’s guide to Documentum