New York Agreement with Sponsor for Research on New Product or Process
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How to fill out Agreement With Sponsor For Research On New Product Or Process?
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FAQ
Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).
At that point, FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug's proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug's identity, strength, quality, and purity.
A Sponsored Research Agreement (SRA) is a contract between Yale and a sponsor for the purposes of funding and conducting research at Yale. A SRA may be supported by a for-profit (e.g., private industry) or non-profit (e.g., state or federal government, foundations, etc.) sponsors.
Which of the following is a criterion for determining if a study of an approved drug is exempt from the require of an IND? The study is not intended to be reported to FDA to support a new indication or support a labeling change.
In broad strokes, sponsor oversight includes verification of the delegated clinical research responsibilities to assure data integrity and patient safety. Certain technologies and processes are helpful for efficient sponsor oversight in clinical trials.
Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols
Under which circumstance does the FDA allow verbal consent prior to participation in a research study? The study is minimal risk.
All research requires a sponsor. The sponsor is the individual, company, institution or organisation that takes on legal responsibility for the initiation, management and/or financing of the research.
Which of the following reports must be filed using an Form FDA 1572? In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: Conduct or supervise the investigation personally.
Oversight by the sponsor can be demonstrated by review and approval of documentation (e.g. Monitoring Visit Reports (MVRs), Data Management Plans, Statistical Analysis Plans, review of deviation logs, audit trails etc.).
