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The essential documents for clinical trials are the following: Investigators Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form. Clinical Study Reports. Case Report Form (CRF)
Purpose of Source Documents: The purpose of source documents is to document the existence of the research subject and substantiate the integrity of the research data collected. Source documents should include original documents related to the research, to medical treatment and to the history of the subject.
Other ways to find a clinical trial Talk to your health care provider about studies that may be right for you. Join a national registry of research volunteers, such as ResearchMatch . Join the NIH All of Us Research Program , which is enrolling a large group of people that reflects the diversity of the United States.
The four main phases of clinical trials, which will be explained further below, are: Phase 1 - Assessing initial safety and dosage Phase 2 - Evaluating effectiveness and side effects Phase 3 - Confirming efficacy compared to standard treatments Phase 4 - Ongoing study of long-term effects after approval Understanding
Form FDA 1572 (Statement of Investigator) The Form FDA 1572, otherwise known as the Statement of Investigator, is one of the most important documents in a clinical trial because it shows the sponsor that the PI (principal investigator) will comply with all FDA regulations.

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Clinical Study: Documentation plays a vital role in clinical study or scientific research. It validates how authentic the research data was collected and verify the result of data. Clinical practice documentation is essential for communication among healthcare providers.
Fees of Clinical Trial Approval in India The basic fee is 3,00,000 Rupees for Phase I (human) clinical trials. 2,00,000 Rupees for Phase II (exploratory) clinical trials. 2,00,000 Rupees for Phase III (confirmatory) clinical trials.

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