Can a document index replace the matrix?

No. An index locates files; the matrix connects scientific claims, supporting evidence and remaining uncertainty.

Does IND delivery automatically authorize recruitment?

No. Evaluate IND effectiveness, FDA communications, IRB conditions and site-specific start requirements separately.

Preparing an initial IND: a clinical-start evidence matrix

Published: 27 October 2026
Updated: 27 October 2026
Sources checked: 27 October 2026

An initial IND needs a coherent explanation of why the proposed human investigation is supported. Sponsors can use an evidence matrix to connect product quality, nonclinical findings and the clinical protocol before publishing the submission package.

Start with the investigation

21 CFR 312.23 provides the framework for IND contents. Fix the product, indication, population, dose and route first. Locate the rationale supporting the proposed exposure and identify unresolved scientific uncertainty rather than treating document volume as evidence of readiness.

Build an evidence matrix

Create a table linking each protocol claim to a CMC, pharmacology or toxicology report. Include the document version, data owner, reviewer and open question. Challenge the comparability of material used in supporting studies and material intended for clinical use.

Run a cross-document review

Review the package across disciplines. Inconsistent dose units or product codes can escape separate document reviews. Distinguish the presence of a report from the consistency of its conclusions with the protocol; assign disagreements for resolution before final approval.

Reconcile the clinical dose rationale against toxicology exposure.
Match CMC lot information to the protocol product.
Assign missing reports an owner and decision impact.

Record the start decision

Track IND effectiveness separately from technical delivery. The FDA receipt record, any clinical hold and applicable IRB conditions belong in the start assessment. Preserve the impact of remaining questions and the evidence used by the sponsor when authorizing subsequent activities.

Frequently asked questions

Can a document index replace the matrix?: No. An index locates files; the matrix connects scientific claims, supporting evidence and remaining uncertainty.
Does IND delivery automatically authorize recruitment?: No. Evaluate IND effectiveness, FDA communications, IRB conditions and site-specific start requirements separately.