Compiling an IND Annual Report

Information needed to meet the requirements of compiling an IND Annual Report to be submitted to the FDA Annual Reports 312.33
A sponsor shall within 60 days of the anniversary date that the IND went into effect (i.e., the date the FDA permitted the study to begin) submit a brief report of the progress of the investigation.

Individual study information

• A brief summary of the status of the study during the previous year. It must include:
  • Study title, its purpose, statement identifying the patient population, whether the study is completed.
  • Total number of subjects planned for inclusion; number entered to date tabulated by age, gender, and race; number of subjects who completed the study; number of subjects who dropped out of the study for any reason.
  • A brief description of any available study results.

Summary information - IND Annual Report Checklist

• A narrative or tabular summary showing the most frequent and most serious adverse events by body system.
• A summary of all IND safety reports submitted during the past year.
• A list of all subjects who died during participation with the cause of death.
• A list of subjects who dropped out because of an adverse experience, whether or not thought to be drug related.
• A brief description of information that was learned regarding the drug s actions (e.g., dose response, bioavailability).
• (If applicable) A list of preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major findings.
• (If applicable) A summary of any significant manufacturing or microbiological changes made during the past year.

General investigational plan

A description of the general investigational plan for the coming year. It should include: rationale; indications; general approach in evaluating the drug; clinical trials to be conducted; estimated number of patients; and risks.

Investigator brochure

A statement that an investigator brochure is not required for an investigator sponsored IND.

Protocol modifications

A description of any significant protocol modifications made during the previous year and not previously reported to the IND in a protocol amendment.