Checklist: Module 2 to Module 3-5 Source Consistency Reconciliation

This is a ready-to-use checklist for the single most common eCTD deficiency pattern: a Module 2 summary that states a number, conclusion, or specification inconsistent with the Module 3, 4, or 5 source it is supposed to summarize. Run this as a deliberate QC step before publishing, not as an afterthought after the sequence is built. Replace every <<FILL: ...>> placeholder. This content is educational reference, not legal or regulatory advice.

Field	Entry
Application / sequence	`<<FILL>>`
Reviewer	`<<FILL>>`
Date	`<<FILL>>`

Section A, Quality Overall Summary (2.3) vs Module 3

#	Item	P/F/NA	Evidence
A1	Every specification limit stated in 2.3 matches the corresponding limit in 3.2.S.4 / 3.2.P.5 exactly	`<<FILL>>`	`<<FILL>>`
A2	The manufacturing process description in 2.3 matches the process described in 3.2.P.3, including any recent change	`<<FILL>>`
A3	Stability conclusions and proposed shelf life in 2.3 match the data and conclusions in 3.2.P.8 / 3.2.S.7	`<<FILL>>`
A4	Impurity limits and identification thresholds in 2.3 match 3.2.S.3.2 / 3.2.P.5.5	`<<FILL>>`

Section B, Nonclinical Overview/Summary (2.4, 2.6) vs Module 4

#	Item	P/F/NA	Evidence
B1	Study NOAELs, exposure margins, and key findings cited in 2.4/2.6 match the actual study reports in Module 4	`<<FILL>>`	`<<FILL>>`
B2	Every pivotal nonclinical study referenced in the overview exists as a report in Module 4 (no citation to an unfiled study)	`<<FILL>>`

Section C, Clinical Overview/Summary (2.5, 2.7) vs Module 5

#	Item	P/F/NA	Evidence
C1	Primary and key secondary endpoint results stated in 2.5/2.7 match the results in the corresponding CSR (Module 5) exactly	`<<FILL>>`	`<<FILL>>`
C2	Safety conclusions (serious adverse event counts, discontinuation rates) in 2.5/2.7 match the CSR safety tables	`<<FILL>>`
C3	Every clinical study referenced in the overview and summary is listed and filed in Module 5, with no omitted study	`<<FILL>>`
C4	Where analysis datasets (ADaM) are filed, the reported result in 2.7 and the CSR can be re-derived from the dataset	`<<FILL>>`

Section D, Completeness

#	Item	P/F/NA	Evidence
D1	No study or analysis known to exist was omitted from the submission, favorable or unfavorable	`<<FILL>>`	`<<FILL>>`
D2	Every source document used to write Module 2 was the current, approved version, not a superseded draft	`<<FILL>>`

Acceptance criteria

Every item is Pass or a documented, justified N/A before the sequence proceeds to validation.
Any Fail is resolved by correcting the summary or the source, whichever is wrong, and re-checking the pair, not by editing the summary alone without confirming why it diverged.
Completeness items (Section D) carry an explicit statement, not silence, that nothing was omitted.

Signoff

Role	Name	Signature	Date
Reviewer	`<<FILL>>`
Quality assurance	`<<FILL>>`

References

ICH M4 (R4), Organisation of the Common Technical Document, and sub-guidelines M4Q, M4S, M4E. FDA data integrity guidance, Data Integrity and Compliance With Drug CGMP, Questions and Answers (2018), for the completeness expectation.

Confirm the current version of each reference before issue.

Filled specimen

A partial completed checklist catching a real mismatch. Illustrative only.

#	Item	P/F/NA	Evidence
A1	Specification limit in 2.3 matches 3.2.P.5	Fail	2.3 states impurity limit “not more than 0.5%”; 3.2.P.5.1 was updated to “not more than 0.3%” in this sequence and 2.3 was not
C1	Primary endpoint result in 2.5/2.7 matches the CSR	Pass	Cross-checked against CSR Table 14.2.1, values match exactly
D1	No study or analysis omitted	Pass	Confirmed against the master study list; all completed studies for this indication are filed

Finding A1 is exactly the pattern this checklist exists to catch: a specification tightened in Module 3 as part of this sequence, with the QOS narrative in Module 2 not updated to match. Resolution here is to update 2.3 to state 0.3%, re-run this checklist against the corrected version, and confirm the content plan’s lifecycle map (see the eCTD content plan template) reflects both leaves as part of the same coordinated change.

Common inspection findings this checklist prevents

Module 2 states a number, limit, or conclusion inconsistent with the Module 3, 4, or 5 source, the single most common reviewer deficiency in eCTD submissions.
A study or analysis is referenced in the overview but does not exist as a filed report.
A reported result cannot be re-derived from the submitted analysis dataset.
A summary was finalized against a draft or superseded source and never reconciled after a late change.

How to adapt this checklist

Set your application and sequence in the header.
Add product-specific reconciliation points (for example a biologic’s comparability conclusions in 2.3 against 3.2.S.7 comparability data).
Run this checklist as a deliberate step before publishing begins, and again after any late change to source documents, not only once at the end.
Confirm every regulation in the references against the current published version before issue.

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