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IND / IMPD Submission Readiness Checklist

Esta lista de verificación está en inglés.

Confirms that the quality, nonclinical, and clinical content required for an Investigational New Drug application or Investigational Medicinal Product Dossier is complete before submission. Use as a pre-submission gating review.

21 CFR 312ICH M4 (CTD)EU Clinical Trials Regulation 536/2014ICH Q1/Q7

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Administrative and Regulatory

  • Are the required application forms and cover letter complete (e.g., FDA Form 1571 for IND)? *
  • Is the submission compiled in the required format (eCTD / CTD)? *
  • Are the sponsor, investigator, and monitoring commitments documented? *
  • Record the target submission date.

Quality / CMC (Module 3)

  • Is drug substance information (manufacture, characterization, control, stability) provided? *
  • Is drug product composition, manufacture, and control described? *
  • Are specifications and analytical methods provided with validation/verification status? *
  • Is stability data sufficient to support the proposed clinical use period? *
  • Is GMP manufacture of the investigational product confirmed? *

Nonclinical (Module 4)

  • Are pharmacology and pharmacokinetics data provided to support the proposed dosing? *
  • Are toxicology studies conducted under GLP and adequate to support the clinical duration? *
  • Is a safety pharmacology assessment included? *
  • Does the integrated summary support a safe starting dose? *

Clinical Protocol and IB (Module 5)

  • Is the clinical protocol complete with objectives, design, and safety monitoring? *
  • Is the Investigator's Brochure current and consistent with the submission? *
  • Are dose rationale and stopping/safety criteria justified? *
  • Are informed consent and subject protection provisions in place? *

Cross-Functional Review and Sign-off

  • Is the dossier reviewed for consistency across quality, nonclinical, and clinical sections? *
  • Are all cross-references and lifecycle/version controls verified? *
  • Is regulatory, quality, and clinical sign-off obtained before submission? *
  • Final authorization to submit. *

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