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eCTD content plan

Shape your submissions

by standardizing documents and data

For many years, Qdossier developed and improved its home grown eCTD content plan. The eCTD content plan provides a comprehensive planning and overview of the eCTD submission outline and drives standardization of documents and data across products and registrations.  In addition, support of other dossier formats (such as PIP, non-eCTD electronic submissions and ASEAN-CTD to prepare submissions) is included. 

eCTD content plan benefits

Auto-generated document titles and file names

Auto-generation of document titles and file names for consistency within and across dossiers, transparent eCTD lifecycles, and optimal reuse of documents.

Life cycle management of submission documents

Highlight documents to be replaced, deleted or added as new. Select from different options for granularity (fine or coarse document granularity) and indicate differences in the naming.

Optional and mandatory metadata

Use of optional and mandatory naming attributes for automatic inclusion in syntax for titles and output file names to drive standardization and technical compliance.

Prefilled document headers, footers and properties

Document header information and prefilled document naming properties with naming suggestions to ensure consistent use of metadata and allow for optimal reuse of contents.

Highlight the reuse of contents

Highlight whether multiple occurrences of single documents are present across modules, sequences and products. 

Support for regions and different dossier formats

M1 Regional Information for CA, CH, EU and US (Others in development)

ICH M2-M5

ASEAN Parts 2, 3 and 4 

Study Tagging Files, CRFs and Datasets

The combined power of eCTD document templates and content plan

The granularity and naming of the submission document templates and submission content plan are compliant and follow the same principles. Together they form a powerful and practical tool set. Both, the Qdossier submission document templates and submission content plan can also be used (and aquired) separately.

The submission content plan enables authors to apply the best document granularity and to harmonize authoring-, naming-, cross-referencing- and archiving practices. In addition, it provides a common understanding across all contributors involved in the preparation and retrieval of regulatory documents and management of a regulatory dossier. 

The content plan guides the publishers regarding the use of eCTD attributes. For instance, applicable to the sequence, individual modules and individual documents. Moreover, it guides the publishers on the lifecycle operation values and the need for creating hyperlinks between documents. In more exceptional cases, it also shows how to manage multiple occurrences of the same document at various locations in a dossier.

Implicitly, the content plan serves as a Quality Control tool before dispatch. For example, it is used for checking the actual naming of documents in the eDMS and eCTD, the completeness of the submission in the electronic submission management tool and the proper lifecycle within submissions. The systematic approach and harmonized definition of document names and the submission outline, results in optimal reusability of documentation across products, countries, submission types and formats. As a result, it ensures reliable hits when querying data-, document- and/or dossier repositories.

Qdossier offers fine tuning and customization of the content plan. For example, by including company specific documents, metadata and terminologies. In addition, we can provide regular version updates, training and training materials.

More information

Maikel Bouman

Maikel Bouman
+31 416 707 998
contact

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