IND Annual Reports

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Overview

IND Sponsor-Investigators are expected to submit brief annual reports of the progress of the investigations conducted under their IND application within 60 days of the anniversary date that the application went into effect.

Annual Report Requirements

The following information should be included in the annual report:

  • Individual Study Information: A brief summary of the status of each study in progress and each study completed during the previous year. The summary is expected to include the following information for each study:
    • The title of the study (with any appropriate study identifiers such as protocol number), its purpose, a brief statement identifying the patient population, and a statement as to whether the study is completed.
    • The total number of subjects initially planned for inclusion in the study; the number entered into the study to date, tabulated by age group, sex, and race; the number of participants who completed the study; and the number who dropped out of the study for any reason.
    • A brief description of any available study results. Publications related to the trial can be submitted/referenced.
  • Summary Information: Information obtained during the previous year's clinical and nonclinical investigations conducted under the IND application, including:
    • A narrative or tabular summary showing the most frequent and most serious adverse experiences by body system.
    • A summary of all IND safety reports submitted during the past year.
    • A list of subjects who died during participation in the investigation, with the cause of death for each subject. (Note, no personal identifiable information (PII) should be included.)
    • A list of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug related. (Note, no personal identifiable information (PII) should be included.)
    • A brief description of what, if anything, was obtained that is pertinent to an understanding of the drug's actions, including, for example, information about dose response, bioavailability, or relevant information from controlled trials.
    • A list of the preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major preclinical findings.
    • A summary of any significant manufacturing or microbiological changes made during the past year.
  • Update to General Investigational Plan: A description of the general investigational plan for the coming year to replace that submitted one year earlier.
  • Update to the Investigator's Brochure: If the Investigator's Brochure has been revised, a description of the revision and a copy of the new brochure.
  • Significant Protocol Updates: A description of any significant Phase 1 protocol modifications made during the previous year and not previously reported to the IND in a protocol amendment.
  • Update on Foreign Marketing Developments: A brief summary of significant foreign marketing developments with the drug during the past year, such as approval of marketing in any country or withdrawal or suspension from marketing in any country.
  • Log of Outstanding Business: If desired by the sponsor, a log of any outstanding business with FDA with respect to the IND application for which the sponsor requests or expects a reply, comment, or meeting.

Submitting IND Annual Reports to the FDA

It is recommended that Sponsor-Investigators of IND applications submit Protocol and Information Amendments through the method used for submitting the initial IND. This will typically be electronically through the CDER NextGen Porta external site (opens in a new window) l or the FDA Electronic Submissions Gateway (ESG) external site (opens in a new window) , or as a hard-copy submission directly to the FDA.

FDA Guidance and UCSF Templates

FDA Guidance

UCSF Templates

Annual Report