All requests for modification must be received by the IRB in sufficient time to allow approval. Major modifications: design or goal change or anything that increases risk more than slightly needs full board approval. Examples: recruitment materials, changes that reduce risk, changes in administrative nature such as address or phone number. Minor modifications: changes that reduce risk or increase it only slightly. Minor changes in research typically qualify for review by expedited process.
Examples: recruitment materials, changes that reduce risk, changes in administrative nature such as address or phone number Addition of investigators or devices within protocols approved for such additions are minor modifications.
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. Update to General Investigational Plan - A description of the general investigational plan for the coming year to replace that submitted 1 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.
An IND application may be withdrawn by the applicant if development of the investigational product has been abandoned for any reason. If an IND is terminated, the sponsor must end all clinical investigations under the IND and recall or otherwise provide for the disposition of all unused supplies of the drug.
Termination is typically based on safety issues or deficiencies in the IND or in the conduct of the investigation. Immediate termination of an IND may occur if at any time FDA concludes that continuation of the investigation presents an immediate and substantial danger to the health of individuals. Please visit the FDA web site for more information. IND Maintenance. Drugs IND Maintenance. Safety Reporting 21 CFR Such reports should be submitted without delay, as soon as the information is available but no later than 15 calendar days after the sponsor receives the information Safety Report submission format Narrative or Form FDA A Mandatory MedWatch Form FDA A — For clinical trial safety reports, for use by IND reporters, manufacturers, distributors, importers, user facilities personnel Do not use: Form FDA Voluntary MedWatch , which is used by healthcare professionals, consumers, and patients.
Annual Reports 21 CFR 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, gender, 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.
Changes to existing protocol s should be identified as "Protocol Amendment: Change in Protocol" A sponsor of an IND application is expected to submit a protocol amendment in cases when there are changes in the existing protocol that significantly affect safety of subjects, scope of the investigation, or scientific quality of the study. Such amendment should contain a brief description of the change and reference date and number to the submission that contained the original protocol.
For example, changes requiring an amendment to an IND application may include:. Any increase in drug dosage or duration of exposure of individual subjects to the drug beyond that described in the current protocol, or any significant increase in the number of subjects under study. Any significant change in the design of a protocol such as the addition or elimination of a control group.
Addition of a new test or procedure intended to improve monitoring for, or reduce the risk of, a side effect or adverse event; or elimination of a test intended to monitor safety.
For example, changes requiring an amendment to an IND application may include: Any increase in drug dosage or duration of exposure of individual subjects to the drug beyond that described in the current protocol, or any significant increase in the number of subjects under study.
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