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What belongs in the Module 5 clinical study listing?
The 5.2 listing identifies the clinical studies and directs reviewers to their reports. Reconcile study objectives, design, products, participants, duration, report location and status against the actual evidence package. Distinguish ongoing studies from final or interim reports; a catalog heading does not make every study type mandatory.
Before you begin
Clinical evidence organized for FDA submissions. The M4E marketing-application organization does not determine the studies needed for a particular IND, NDA, BLA or ANDA.
What you will prepare: A reconciled study listing, report-location map and explicit disposition for missing or unavailable material.
Sections covered in this guide (2)
Start from the program records, including inconvenient studies
Collect the clinical study register, submission plan, report tracker and records of studies available from partners or published sources. Establish the intended application, indication, submission purpose and data cutoff before excluding anything. A discontinued program, negative result or unfinished report is a disposition to explain, not an automatic reason to remove the study from the inventory.
Create an internal reconciliation record with the study identifier, primary objective, population, report status, responsible owner and proposed location. For an ongoing study distinguish the study's status from the maturity of the submitted report. “Ongoing; interim report through the stated cutoff” conveys something different from “complete.” If ownership or access is unknown, assign resolution rather than declaring the study absent.
Prepare a 5.2 row that helps a reviewer find the evidence
M4E Table 5.1 provides the starting fields: study type and identifier, report location, objectives, design and control, products/regimen/route, participant information, duration and study/report status. Use controlled report information to populate the table. Define the meaning of participant counts; randomized, treated and analyzed are not interchangeable.
As an editorial working method, build one traceable record per study and associate each applicable report version with it. Use the actual electronic destination when preparing the submission, rather than copying the paper-volume examples from the guidance. Follow the Module 5 organization or explain a different sequence. Reconcile the table against the report packages after publishing operations finish; a correct spreadsheet can still point to an obsolete file.
Choose the report family by the question the study answers
Use biopharmaceutics for availability or formulation comparison; human-biomaterial sections for relevant in-vitro or ex-vivo PK work; human PK or PD for the corresponding primary objective; and efficacy/safety sections for studies contributing that evidence. Population PK analyses have their own location. Marketing-experience reports and literature support different review tasks again.
M4E generally recommends a single report location with cross-references for other objectives. Apply its specific family instructions when a study spans categories. Do not duplicate a CSR under PK, PD and efficacy merely because all three outcomes appear. The shared FDA electronic catalog also differs from historical paper CTD headings; a number in an older content guideline is not permission to create an electronic node.
Resolve a mixed-objective study before closing the inventory
Fictional exercise: study CL-204 is a controlled efficacy trial with an embedded PK cohort. Its CSR appears in the efficacy family; the pharmacology summary points to the relevant results. A separately authored population PK analysis that pools CL-204 with other studies is a different report and can have its own 5.3.3.5 entry.
If the primary objective is unavailable, keep placement undetermined until the protocol and regulatory owner resolve it. If the pathway changes from a marketing application to an IND amendment, revisit the intended submission package; do not carry over the entire marketing dossier by default. Review success means every inventory item has a supported disposition and every submitted report can be found, not that every catalog heading contains a file.
Reconcile study identity, report status and submission disposition
Use three separate fields for study status, report status and submission disposition. Combining them into a single “complete” column conceals whether a completed study has an available final report.
| Working record | Example of the distinction | Evidence to inspect |
|---|---|---|
| Study identity | Sponsor and partner codes for the same study | Protocol identity and documented code mapping |
| Study status | Follow-up continues after enrollment ends | Actual conduct and cutoff records |
| Report status | An interim report exists; final CSR is pending | Controlled report version and data cutoff |
| Submission disposition | Included, cross-referenced, omitted with rationale or unresolved | Submission plan and responsible review |
| Reviewer destination | One primary report location with additional references | Actual assembled package |
Inventory exercise: a partner report has a different study code and appears to be an additional trial. Resolve the code relationship before counting studies or participants. If it is the same study, retain the alias so citations remain understandable; if it is different, establish its own evidence record. Similar titles are insufficient to decide.
Link each report to the synopsis inventory and its supporting-file manifest. Close a listing discrepancy only after checking the actual destination, not merely the intended filename.
Your preparation checklist
0/4 checkedUse this to track your review in this visit. Checks are not saved and do not establish regulatory compliance.
Frequently asked questions
Should an ongoing study be labeled complete when its interim report is final?
No. A final version of an interim report does not mean the study is complete. State the study’s actual status and the submitted report’s cutoff and maturity separately. This lets reviewers understand what evidence is available and what follow-up remains ongoing.
Should one CSR be copied into every relevant Module 5 family?
Generally use the appropriate primary report location and meaningful cross-references, applying the family-specific M4E instructions. A study can contribute to several scientific questions without requiring independently maintained CSR copies. Separate analysis reports can have their own justified locations and identities.
Are randomized, treated and analyzed participant counts interchangeable?
No. These counts describe different populations and can legitimately differ. Define the count used in the listing and reconcile it with the controlled report. An unexplained discrepancy requires review; making all numbers identical can conceal the actual study conduct.
Does the Module 5 hierarchy determine the studies required for an IND?
No. The CTD organization is not a universal development-program checklist. Determine the actual submission purpose, pathway and evidence needs separately. Use the hierarchy to make the selected evidence retrievable, with a supported disposition for omitted or unresolved material.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
Guidance
FDA M4E(R2): The CTD: Efficacy ↗July 2017, Revision 1, final. Module 5, printed pp.56–64. Organization guidance, not a list of studies required for every application. Reopened September 22, 2026.
Guidance
FDA E3 Questions and Answers (R1) ↗January 2013 final; Q1–Q3 on flexible structure, synopsis and appendices; Q6–Q8 on terminology. Reopened September 22, 2026.
Technical specification · placement only
FDA eCTD v4.0 comprehensive hierarchy ↗Version 2.2, February 2025. Section 5.2. A heading identifies placement, not mandatory applicability.