eCTD & Publishing

CTD/eCTD structure, lifecycle, validation, and electronic submission operations

19 terms

The XML structure of an eCTD submission that provides metadata, hierarchy, and lifecycle instructions for submitted documents (leaves).

PDF Bookmarks

Structured navigation elements within PDFs that help reviewers quickly locate sections; often expected for large dossiers and reports.

Checksum

A file integrity value used to verify that a file was not altered during transfer, helping confirm submission integrity.

Cover Letter

A submission letter that introduces the purpose of an application/sequence and highlights key items (e.g., submission type, content, cross-references, contacts).

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eCTD & Publishing

CTD/eCTD structure, lifecycle, validation, and electronic submission operations

19 terms

eCTD Backbone

The XML structure of an eCTD submission that provides metadata, hierarchy, and lifecycle instructions for submitted documents (leaves).

PDF Bookmarks

Structured navigation elements within PDFs that help reviewers quickly locate sections; often expected for large dossiers and reports.

Checksum

A file integrity value used to verify that a file was not altered during transfer, helping confirm submission integrity.

Cover Letter

A submission letter that introduces the purpose of an application/sequence and highlights key items (e.g., submission type, content, cross-references, contacts).

Common Technical Document(CTD)

A harmonised dossier format for marketing applications. Modules 2–5 are harmonised; Module 1 is region-specific administrative/prescribing content.

Electronic Common Technical Document(eCTD)

The electronic format of CTD used for regulatory submissions, managed via sequences and lifecycle operations under regional technical specifications.

eCTD 4.0

A newer eCTD specification that modernizes lifecycle management and data exchange capabilities (adoption varies by region and authority timelines).

eCTD Granularity

How content is split into documents/leaves in an eCTD to support lifecycle operations and reviewer navigation.

eCTD Lifecycle

Rules and operations (new/replace/append/delete) that govern how documents evolve across eCTD sequences so reviewers can identify the current version and history.

eCTD Sequence

A numbered eCTD submission unit (initial, amendment, response, supplement) that contains lifecycle-managed documents for an application.

eCTD Validation

Technical checks to confirm an eCTD meets regional specs (structure, metadata, links, file formats) prior to acceptance/review.

Hyperlinking (Submissions)

Creating links within and between documents (e.g., from summaries to reports) to improve reviewer navigation, while ensuring links remain valid across lifecycle operations.

Leaf (eCTD)

A single document node in the eCTD backbone, with associated metadata (title, ID, operation, checksum) that points to a file such as a PDF.

Non-eCTD electronic Submissions(NeeS)

A legacy electronic submission format used in some regions prior to full eCTD adoption, with structured folder conventions but limited lifecycle capabilities.

PDF/A

A PDF standard intended for long-term archiving; regulators often require or recommend PDF/A for certain submission documents to ensure readability over time.

Regional Module 1

The region-specific CTD/eCTD module containing administrative and prescribing information; differs across regions and authorities.

Study Tagging File(STF)

An eCTD file used to tag and classify studies/outputs, helping reviewers navigate and understand relationships between study reports and datasets.

Electronic Submission Gateway(ESG)

An electronic portal used to transmit regulatory submissions and related communications to an authority (e.g., FDA) in secure, standardized formats.

Validation Report (eCTD)

A report produced by eCTD validation tools summarizing errors and warnings against regional technical criteria, used to resolve issues before submission.