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Resources for Clinical UNMC Guides

The Clinical Research Center (CRC)is an outpatient clinical research facility that supports a broad range of clinical trials. The CRC contains exam rooms, procedure rooms, a dental/ENT room, a treadmill room, a phlebotomy room, a coordinator/investigator … See more

Actived: 4 days ago

URL: https://guides.unmc.edu/books/research-handbook/page/resources-for-clinical-research

3.4 Use of Protected H UNMC Guides

WEB3.0 Definitions. 3.1. Protected Health Information (PHI) is individually identifiable health information, whether oral or recorded in any medium, that: 3.1.1. Is created or received …

Category:  Health Go Health

Human Subjects Protect UNMC Guides

WEBSchedule training through the Clinical Research Manager at 402-552-6601 or the Senior Clinical Trials Analyst at 402-552-7817. One Chart Electronic Health Record training is …

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Managing Clinical Trials UNMC Guides

WEBBuilding a study. Only those designated as Clinical Research Specialists can build and activate studies. Research coordinators must submit a completed Clinical Trial Master …

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Environmental Health a UNMC Guides

WEBRadiation Safety also manages the personnel radiation monitoring program (e.g., radiation badging, bioassays). Prior to working with radioactive material, please contact EHS at …

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Research Space and Sup UNMC Guides

WEBPhone: 402-559-7685. A separate Clinical Research Unit is available at the Omaha VA Hospital and Medical Center. This facility is available to Omaha VA investigators or …

Category:  Medical Go Health

3.12 Ethical Access UNMC Guides

WEB3.0 Ethical Access for Recruitment of Subjects. For the purposes of this policy, the recruitment of subjects requires two distinct activities, each of which must respect the …

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5.2 Waiver or Alterati UNMC Guides

WEB6.1. The IRB may allow a waiver or alteration of informed consent in FDA regulated research provided the requirements of 45 CFR 46.116 (f) at met; specifically. …

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UNeHealth UNMC Guides

WEBUNeHealth serves to facilitate the growth and development of industry-funded clinical research, and acts as the contracting arm for industry-funded clinical research on behalf …

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Funding UNMC Guides

WEBThe “Innovation Micro-Grant Program” is designed to further develop an early stage technology if the “proof of concept” work proves promising. Additional information can be …

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1.20 Community Involvement in Outreach Activities and …

WEBThe purpose of this policy is to describe the Organization’s outreach activities to enhance the public’s understanding of research, obtain feedback about any community concerns, …

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1.8 Investigational Ac UNMC Guides

WEB3.2.7. Investigational Device: An investigational device means a device, including a transitional device, which is the object of a clinical investigation. As further defined, a …

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3.3 Privacy Interests UNMC Guides

WEB3.3. Protected Health Information (PHI) is defined as individually identifiable health information, whether oral or recorded in any medium, that: (1) is created or received by …

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5.2 Waiver or Alteration of Informed Consent and HIPAA …

WEB3.0 Criteria for Waiver or Alteration of Consent under HHS regulations and HIPAA regulations. 3.1. The IRB may allow a waiver or alteration of informed consent and …

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4.6 IRB Review of Research Involving Subjects with Impaired …

WEB2.0 Policy. It is the policy of the Organization that research involving subjects who have impaired decision-making capacity must include appropriate additional protections in …

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8.1 Review of Adverse UNMC Guides

WEB3.1. Adverse Event (AE) is defined as any untoward or unfavorable occurrence in a human subject temporally associated with the subject’s participation in the research (whether or …

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3.3 Privacy Interests and Confidentiality of Research Data

WEBThe purpose of this policy is to describe the Organization’s requirements for 1) protection of privacy interests of research subjects, and 2) maintenance of confidentiality of data.

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8.1 Review of Adverse Events and Adverse Device Effects

WEB6.3.1. Re-consent must be obtained from currently enrolled subjects, and, if so, how soon such re-consent must occur. 6.3.2. Currently enrolled subjects may continue on study.

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3.11 Collecting Data from Pregnant Partners of Research …

WEB5.1. Informed consent must be obtained and documented from the pregnant partner in accordance with HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).

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