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IRB Review Types Emory University Atlanta GA

WebEmory currently has six different boards which meet to review biomedical studies and a board specifically for socio-behavioral research, as well as a board which reviews non …

Actived: 2 days ago

URL: https://irb.emory.edu/guidance/getting-started/irb-review.html

Home Emory University Atlanta GA

WebThe mission of the Emory Human Research Protection Program is: to safeguard and promote the dignity and well-being of participants in research conducted at or by Emory …

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Does My Project Need IRB Review

WebThe Common Rule defines a human subject as a living individual about whom an investigator conducting research obtains (1)information or biospecimens through …

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Looking for a Study

WebIf you are looking for a study in which to participate, Emory Healthcare has a database of open trials: Also, you can go to the government's clinical trials website to search for trials …

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Clinical Study Initiation and Tools Emory University

WebThese tools were created in cooperation with the Clinical Trials Audit and Compliance Office (CTAC) and the Emory Office of Compliance for use by Investigators and their study …

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MEDICAL RESEARCH: A CONSUMER’S GUIDE FOR …

WebPhase II is the stage where scientists start to measure whether the product works in humans. The drug is tested on about 100 to 500 participants. Because this phase of …

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Courses Emory University Atlanta GA

WebCourses. Training is crucial to the ethical and compliant conduct of human research. The IRB has certain basic requirements, below. We also ensure that Emory-required clinical …

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SaaS eIRB (New eIRB) Emory University Atlanta GA

WebThe new eIRB has links in each migrated study to view the study in our old (RX) eIRB. You will only be able to use the link if you have an account in our old RX system, and if you …

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Consent Toolkit Emory University Atlanta GA

WebConsent Toolkit. Consent Toolkit. Below are the templates for biomedical, sociobehavioral, verbal and assent forms, and "modular language" to plug in if applicable …

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Policies and Procedures

WebEmory University IRB P&Ps Revised May 24 2021 Table of Contents Page 5 of 413. 42 CRITERIA FOR EMORY IRB APPROVAL OF RESEARCH. 158 43. INFORMED …

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Study Submission Guidance Emory University Atlanta GA

WebInvestigator Justification for IND Exemption (ver 6-28-23) Investigator Checklist for the Use of Schedule I Controlled Substances : Please submit a filled form to Margaret Huber at …

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Training Emory University Atlanta GA

WebInvestigators on FDA-regulated clinical trials will also need to complete additional training in clinical research conduct, per Emory policy. Investigators and staff on NIH-funded study …

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Frequently Asked Questions Emory University Atlanta GA

WebA more detailed look at what may constitute unanticipated problems or noncompliance can be found in the NC/UP Guidance (PDF). You may also use our Reportable Events …

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Waiver of Assent Emory University Atlanta GA

WebPer Emory policy, if the child is younger than 6 years old, assent is not required. If the child is 6 to 10 years old — must obtain subject's verbal assent, unless a waiver is deemed …

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Withdrawal or Termination of Study Participation: How to …

WebBest practice is to ALWAYS obtain a written request to revoke. Note: Any means of documentation will suffice. DOCUMENTING WITHDRAWAL. A member of the study …

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List of 18 Identifiers

WebV8.25.2022 . List of 18 Identifiers . The Emory IRB uses the list of identifiers enumerated in the Privacy Rule to determine if identifiers linked to data can be used

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HIPAA Applicability and Waiver Worksheet

WebBrief Introduction to HIPAA. Emory’s Hybrid Covered Entity. HIPAA Applicability for CHOA/Grady/VA. HIPAA Applicability Worksheet. Choosing an Informed Consent …

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Emory HIPAA Policy Frequently Asked Questions

WebVersion 09/12/2022 Emory HIPAA Policy Frequently Asked Questions • When would HIPAA apply to research records for studies conducted by Emory University? o For studies …

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and Affordable Care Act (“ACA”)

WebDirector of Compliance-Section 1557 and Section 504. Nondiscrimination in Health Care Services and Activities Emory Healthcare Compliance Office 101 W. Ponce de Leon …

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