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IMPACT Clinical Investigators Disclosure of Financial Interests and Arrangements for US FDA Please complete all the information below, including providing your signature where indicated. Once complete,

How to fill out guidance for clinical investigators

How to fill out guidance for clinical investigators

1. Step 1: Read the instructions provided by the regulatory authority on how to fill out the guidance for clinical investigators.
2. Step 2: Start by providing the necessary general information, such as the title of the study and the name of the clinical investigator.
3. Step 3: Clearly state the objective of the study and provide a brief background on the research topic.
4. Step 4: Describe the study design, including the population under study, the inclusion and exclusion criteria, and the treatment interventions.
5. Step 5: Explain the data collection methods, including the types of assessments and measurements that will be used.
6. Step 6: Provide information on the statistical analyses that will be performed on the collected data.
7. Step 7: Clearly outline the risks and benefits of participating in the study, as well as the measures that will be taken to ensure patient safety.
8. Step 8: Discuss the ethical considerations, such as obtaining informed consent and protecting the privacy and confidentiality of the participants.
9. Step 9: Include any additional information required by the regulatory authority, such as site-specific considerations or protocols.
10. Step 10: Review and double-check all the information provided before submitting the guidance for clinical investigators.

Who needs guidance for clinical investigators?

1. Any individual or organization involved in conducting clinical research trials may need guidance for clinical investigators. This includes principal investigators, co-investigators, study coordinators, research nurses, clinical research associates, and sponsors. Regulatory authorities and ethics committees also require this guidance to ensure that proper procedures are followed and patient safety is maintained during the research study.

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