Get the free 21 CFR 312 Subpart D - CFR - Code of Federal Regulations Title 21 - visn2 va

Form Approved: OMB No. 09100014 Expiration Date: August 31, 2011, See OMB Statement on Reverse. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION STATEMENT OF INVESTIGATOR (TITLE

How to fill out 21 cfr 312 subpart

How to fill out 21 CFR 312 subpart:

1. Familiarize yourself with the regulations: Start by thoroughly reading and understanding the requirements outlined in 21 CFR 312 subpart. This subpart provides guidance on the investigational new drug (IND) application process and the responsibilities of sponsors, investigators, and institutional review boards (IRBs).
2. Determine your role: Identify your role within the IND application process. Depending on whether you are a sponsor, investigator, or IRB member, your specific responsibilities may vary. Understanding your role will help you fulfill the necessary requirements outlined in the subpart.
3. Gather relevant information: Collect all the necessary information required for the IND application. This includes detailed information about the study drug, study protocol, manufacturing information, preclinical and clinical data, and safety information. Ensure all data is accurate, complete, and adequately supporting the proposed clinical investigation.
4. Prepare and submit the IND application: Follow the proper format and guidelines specified in the subpart to prepare your IND application. Include all required documentation and forms, such as Form FDA 1571 and 1572. Submit the application to the appropriate FDA division, along with the required fees.
5. Respond to FDA inquiries: Stay proactive in responding to any requests or inquiries from the FDA regarding your IND application. Promptly address any concerns or questions raised by the agency and provide additional information or clarification as needed.
6. Conduct the clinical investigation: Once your IND is approved, proceed with conducting the clinical investigation in accordance with the regulations outlined in the subpart. Adhere to good clinical practice (GCP) guidelines and ensure the safety and welfare of study participants while collecting accurate and reliable data.

Who needs 21 CFR 312 subpart:

1. Sponsors: Pharmaceutical companies or individuals intending to conduct clinical investigations of new drugs or experimental treatments in the United States must comply with the regulations outlined in 21 CFR 312 subpart. Sponsors are responsible for submitting the IND application, coordinating the clinical study, and ensuring compliance with all applicable regulations.
2. Investigators: Physicians or other qualified individuals involved in the conduct of the clinical investigation must also be familiar with 21 CFR 312 subpart. Investigators are responsible for administering the study drug, monitoring participants, collecting data, and reporting any adverse events to the sponsor and the FDA.
3. Institutional Review Boards (IRBs): IRB members who review and approve clinical research protocols must have a thorough understanding of the regulations in 21 CFR 312 subpart. IRBs play a crucial role in safeguarding the rights and welfare of study participants by ensuring the proposed study meets ethical standards and that the risks are minimized.

In summary, individuals involved in the planning, conduct, and oversight of clinical investigations in the United States need to be knowledgeable about 21 CFR 312 subpart. Following the step-by-step process and fulfilling the requirements outlined in this subpart is crucial for successfully filling out an IND application and meeting regulatory obligations.

For pdfFiller’s FAQs

What is 21 cfr 312 subpart?

21 CFR 312 subpart refers to the regulations that govern investigational new drug applications (INDs) for human drugs.

Who is required to file 21 cfr 312 subpart?

Sponsors or sponsors-investigators are required to file 21 CFR 312 subpart when submitting an IND application to the FDA.

How to fill out 21 cfr 312 subpart?

To fill out 21 CFR 312 subpart, sponsors must provide the necessary information about the drug, the proposed study, and any relevant data on safety and efficacy.

What is the purpose of 21 cfr 312 subpart?

The purpose of 21 CFR 312 subpart is to ensure that the FDA receives and reviews necessary information about new drugs before they are tested in humans.

What information must be reported on 21 cfr 312 subpart?

Information that must be reported on 21 CFR 312 subpart includes the drug's chemical composition, proposed use, manufacturing process, preclinical data, and proposed study protocols.

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