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Get OFFICE OF CLINICAL TRIALS Research Study Application Form
Ce of Clinical Trials, Room D336 Executive Offices, TCC, Westchester Medical Center along with 1 copy of each of the following: Complete NYMC Application, including the protocol, investigational brochure, consent & HIPAA forms Completed and signed FDA form 1572 (drug studies) or Investigator s Agreement (device studies) Budget (if the study is to be conducted at Westchester Medical Center, including clinics, or requires WMC ancillary services) Clinical Trial Agreemen.
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D336 FAQ
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The essential documents for clinical trials are the following: Investigator's Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form. Clinical Study Reports. Case Report Form (CRF)
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Completion and submittal of a Personal History Statement (PHS) is the first step of the Background Investigation. The PHS requires compilation of extensive biographical information, fingerprinting, and an interview with a background investigator.
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Use the optional PHS Assignment Request Form to list expertise needed to review your application, exclude reviewers, and request an institute assignment.
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Informed Consent Form is a mandatory document to enroll in a clinical research study. This document provides detailed information to the participant about the study, including its purpose, procedures, potential risks and benefits, confidentiality, and the participant's rights.
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Is proprietary/privileged information included in the application? This field is required. Patentable ideas; trade secrets; or privileged, confidential commercial, or financial information should be included in applications only when such information is necessary to convey an understanding of the proposed project.
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Key to determining if research involves human beings as subjects are these definitions: What is a “living individual?” The specimen/data/information must be collected from live subjects. Cadavers, autopsy specimens, or specimens/information from subjects now deceased in not human subjects.
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"PHS" means the Public Health Service, an operating division of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated.
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How to Join a Clinical Trial Look for options. Review eligibility criteria. Contact the study organizers. Review the study description. Learn about informed consent.
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