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NIH Clinical Trials Requirements, FORMS, and the Common Rule: What You Need to Know November 27, 2017November 27, 2017 Jeannie Barony Director, Human Research Protection Office CHANGES TO THE COMMON

How to fill out nih clinical trials requirements

How to fill out nih clinical trials requirements

1. Determine if your study meets the definition of a clinical trial by referring to the NIH definition.
2. Register your study on ClinicalTrials.gov and obtain a unique ClinicalTrials.gov identifier.
3. Submit any required documents, such as Investigational New Drug applications, to the appropriate regulatory agencies.
4. Follow all NIH reporting requirements, including submitting annual progress reports and final results.
5. Ensure that your study complies with all applicable regulations and guidelines.

Who needs nih clinical trials requirements?

1. Researchers conducting clinical trials funded by the NIH
2. Institutions receiving NIH funding for clinical trials
3. Investigators seeking to publish the results of NIH-funded clinical trials

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What is nih clinical trials requirements?

NIH clinical trials requirements refer to the specific guidelines and regulations set by the National Institutes of Health for the conduct and reporting of clinical trials funded by the NIH.

Who is required to file nih clinical trials requirements?

Investigators and institutions conducting clinical trials that are funded by the NIH are required to comply with the NIH clinical trials requirements.

How to fill out nih clinical trials requirements?

NIH clinical trials requirements can be filled out using the NIH's online system known as the Clinical Trials Reporting Program (CTRP). Detailed instructions on how to fill out the requirements are provided on the NIH website.

What is the purpose of nih clinical trials requirements?

The purpose of the NIH clinical trials requirements is to ensure transparency, accountability, and integrity in the conduct and reporting of clinical trials funded by the NIH. It helps to protect the interests of research participants and the credibility of the research findings.

What information must be reported on nih clinical trials requirements?

The NIH clinical trials requirements mandate the reporting of detailed information about the design, conduct, and results of the clinical trials, including participant demographics, interventions used, outcomes measured, and adverse events reported.