Get the free FDAAA 801 and the Final Rule - ClinicalTrials.gov

Study #: 20170001Approval Date: 1/24/2017Expiration Date: 1/23/2020Patient WellBeing Research Project PARTICIPANT INFORMED CONSENT FORM Purpose: You are invited to participate in a research study.

How to fill out fdaaa 801 and form

How to fill out fdaaa 801 and form

1. To fill out FDA Form 801, follow these steps:
2. Start by entering the estimated completion date of the study in Section 1.
3. In Section 2, provide the title of the study, the name of the sponsor, and the unique protocol identification number.
4. Indicate the type of study in Section 3: Interventional, Observational, Expanded Access, or Other.
5. Section 4 requires information about the FDA-regulated product being studied, including the IND/IDE number and the primary mode of action.
6. In Section 5, list the location(s) where the study will be conducted.
7. Section 6 is for providing contact information of the study's responsible party.
8. Section 7 asks for details about the recruitment status, enrollment goal, and age range of participants.
9. Section 8 involves providing information about the study design and its primary purpose.
10. Complete Sections 9, 10, and 11 if applicable, depending on the nature of your study.
11. Finally, review the entire form for accuracy and completeness before submitting it to the FDA.

Who needs fdaaa 801 and form?

1. FDA Form 801 and the associated FDA Certificate of Compliance are required for all applicable clinical trials conducted under Investigational New Drug (IND) or Investigational Device Exemption (IDE) protocols.
2. This includes studies that are regulated by the Food and Drug Administration (FDA) and involve the testing of drugs, biologics, or medical devices on human subjects.
3. Sponsors and responsible parties conducting such trials are required to fill out FDA Form 801 and submit it to the FDA within 30 days of enrolling the first participant.

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What is fdaaa 801 and form?

fdaaa 801 is a requirement under the Food and Drug Administration Amendments Act (FDAAA) of 2007. Form FDA 801 is used to report certain clinical trial information to the FDA.

Who is required to file fdaaa 801 and form?

Sponsors or responsible parties of certain clinical trials are required to file fdaaa 801 and form.

How to fill out fdaaa 801 and form?

The form can be completed electronically through the FDA's website. It requires information such as trial registration information, study design, and primary outcome measures.

What is the purpose of fdaaa 801 and form?

The purpose of fdaaa 801 and form is to increase transparency of clinical trial information and results, helping to ensure the integrity of biomedical research.

What information must be reported on fdaaa 801 and form?

Information such as trial registration details, study protocol information, and primary outcome measures must be reported on fdaaa 801 and form.