RECORDREFERENCE OUTLINE

IND Application Assembly Record

Assembly record for an investigational new drug application, checking the nonclinical package against the exposure the protocol actually proposes across route, duration, population and margin; deriving the starting dose from a stated point of departure and safety factor; and tracking the review period so dosing does not begin on the assumption that silence is approval. Maps to 21 CFR Part 312.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

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REGULATIONS MAPPED
21 CFR Part 312
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

An IND is the package that persuades a reviewer that participants in the proposed trial are not exposed to unreasonable risk. The review period is short and is not extended because a submission arrived incomplete — it simply runs while the questions accumulate. The characteristic gap is a nonclinical package that supports a neighbouring exposure rather than the one the protocol actually proposes.

What's Inside

✓Application type and scope, establishing what is being sought and which content requirements follow from it
✓Nonclinical package checked dimension by dimension against the proposed exposure: route, duration, population and margin
✓Chemistry, manufacturing and controls content sufficient for the phase and the quantity of material involved
✓Starting dose justification, traced from a stated point of departure through the safety factor applied
✓Dose escalation plan with stopping rules, so escalation is bounded before the first cohort is dosed
✓Clinical protocol, investigator brochure and investigator commitments, cross-checked against each other before submission
✓Review period tracking and the maintenance obligations that begin the moment the application becomes active

How to Use It

1Check the nonclinical package against route, duration, population and exposure margin separately, because a package can pass three and fail one
2Derive the starting dose from a stated point of departure and safety factor; a dose asserted from precedent is not a derivation
3Cross-check the protocol against the investigator brochure before submission, since a reviewer will read the two together
4Do not dose before the review period has elapsed — silence during the period is not the same as its expiry
5Revise the investigator brochure as safety data accumulate, or every later expectedness assessment is made against stale text
6Stand up the maintenance obligations at submission rather than at the first report, because that clock starts immediately
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Application Type and Scope
2Nonclinical Package Against the Proposed Exposure
3Chemistry, Manufacturing and Controls
4Starting Dose Justification
5Clinical Package and Commitments
6Review Period and Maintenance
REGULATORY CONTEXT

21 CFR Part 312 governs investigational new drug applications — content and format, the review period that must elapse before dosing, safety reporting during the trial, and the annual report. It does not decide whether your nonclinical package supports the exposure you propose, what safety factor is appropriate, or when escalation should stop; those determinations belong to the sponsor and are what the reviewer examines. The dimension-by-dimension assembly check is SPEQ synthesis.

MAPPED STANDARDS
21 CFR Part 312
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