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Title: VA HRRP Accreditation Subject: VA HRRP Accreditation Author: Rick Aleman Keywords: VA HRRP Accreditation Last modified by: vhabhsriverp Created Date
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Part 1: Brief Description of the IRB and Research at Lifespan. Part 2: IRB ... forms to research subjects and keep the originals in secured research files ...
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... of informed consent Waiver of documentation of informed consent Research involving vulnerable populations Waiver of HIPAA authorization ... HRPP 101 January ...
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Ethical & Regulatory Oversight of VA Human Subjects Research K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE HRPP 101
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Understand the variety of regulations and other requirements under which the HRPP operates ... The honorarium is under the $10,000 limit. ...
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Use of HRPP's by Users of Hydrological and Mesoscale Forecast Models ... Recommend that countries or weather institutions with high quality ground ...
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Assessing the Quality of VA Human Research Protection Programs Robert Brooks, MD PhD MBA Min-Fu Tsan, MD, PhD Office of Research Oversight * Quality Indicators for VA ...
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... ... P PP P ' ' a G ...
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NCQA Accreditation Update. VA Day. October 28, 2004. Karen Jeans, MSN, CCRA, CCRN. The Big Question ... What (if any) are the NCQA Elements that everyone is missing? ...
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Comments from the Perspective of a Human Research Protections Program that Maximizes Opportunities to be Flexible and Innovative Lois Brako Assistant Vice President ...
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... CFG55-57, 69,70 Reviews of SAE by R&D and IRB not documented 21CFR56.101(a), ... Thus, NCQA accreditation is based on what the facilities have accomplished.
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Carole A. Klove, RN JD. Deloitte & Touche LLP (213) 553-1410. cklove@deloitte.com. 2 ... A Closer Look at Some Key Differences in the Standards. Implications ...
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Discuss how to process the MOU and amend your facility's ... Annette Anderson Hector Ramirez. VA Central IRB Administrator VA Central IRB Coordinator ...
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Comply with all IRB conditions for approval, institutional policy, federal/state ... of regulatory requirements for review and approval of research. Special ...
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Human Research Protection Program 101 March 19-20 Cincinnati, OH Structure of Oversight of Human Subjects Research Objectives Describe the oversight structure of ...
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Institutional Review Board (IRB): The Role and Responsibilities of Information Security Officers (ISOs) Presented by: Randy Ledsome, Acting Director, Field Security ...
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... for feeding and weeding' 5. Landscape ... Feeding & Weeding. On-the-Job training late start, ... Feeding & Weeding. OJT: Adult learning principles. tailored to ...
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Human Research Protection Program & IRB Responsibilities Marisue Cody, PhD Director Center on Advice & Compliance Help
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Determination Letters/Board Modifications 24 hrs 2 business days. PI Addresses Board Mods ... sample informed consent document and to provide details of the ...
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Numerical weather prediction forecasts of precipitation can be used to improve ... United Kingdom, France, Germany, Belgium, Netherlands. UK Met Office ...
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... SKILLED HUMAN CAPITAL FOR HIGH PERFORMANCE AND ENHANCED SERVICE DELIVERY ... system of hardware, software, and databases designed to provide information used ...
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The IRB Chair has a direct or indirect role in each of the ... and experience as an IRB Chair ... evaluate VA appointment for IRB Chairs with a VA IRB? ...
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Questions: AAHRPP Evaluation Instrument for Use with Final Revised Accreditation Standards Presented by: C. Karen Jeans, MSN, CCRN, CIP COACH Program Analyst, PRIDE
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Investigational Pharmacy Issues Debbie Mundie, RPH Aka: The Drug Nazi She should be in Law Enforcement She s nice, but PICKY McGuire VAMC
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Title VHA Research Compliance Reporting Requirements Subject VHA Research Compliance Reporting Requirements Author: Department of Veterans Affairs
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Enhancing the quality of human research protection in VA-funded ... VA Central IRB is final arbiter. Local VA facilities decide whether or not to participate ...
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Purpose and objectives of the strategic framework. HR Planning in the ... Customise strategic interventions. Identification & analysis of skills & competencies ...
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... it uses an external IRB (e.g., affiliate's, another VA's or the VA Central IRB) ... applicable, revise MOU with affiliate] 12. VA Central IRB. Application ...
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... San Diego ... University of California, San Diego. University Center 201. 9500 ... University of California, San Diego. La Jolla Village Professional ...
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Whether institutional or independent, a central IRB serves as a ... Vice President, Chesapeake Research Review, Inc. Felix Khin-Maung-Gyi, Pharm.D, M.B.A., CIP ...
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Do the benefits of the lease outweigh the risks and liability for VA? ... Safety of lessee's staff, environment, VA personnel, patients, or visitors ...
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Property Management Overview ...
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... organization founded in 2001 under the auspices of PRIM&R, the Association of American Medical Colleges (AAMC), FASEB, and several other national ...
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... On-Site Reviews. Types of Reviews. For-Cause. Routine. Reviews Focus on Regulatory Compliance. Identify deficiencies. 13. For-Cause On-Site ... Routine On-Site Reviews ...
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ORD Human Research Protection. K. Lynn Cates, MD. Assistant Chief Research ... How ORD is going to help you optimize human research protection at your facility ...
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IRB = Institutional Review Board (generic) ... 2 Level of Review/Type of Application * Level of review and type of application are determined by level of risk. ...
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... research protection in ORD multi-site studies by ensuring ... PI enlists sites ... not providing all materials required for IRB review in a timely fashion ...
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Facility develops action plan. Continuous follow-up until ... Handbook 1200.5, Requirements for the Protection of Human Subjects in Research (July 15, 2003) ...
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UC is responsible for managing the Laboratory, Berkeley Lab employees are ... Guidance & assistance based on DOE compliance rules ...
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410-884-2900 www.chesapeakeirb.com. The Third Annual ... Additional Protections for Children. Subpart D Children as Subjects in Research ... psyche state ...
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How ORD is going to help you optimize human research protection ... PRIM&R, AAMC, Kaiser-Permanente. NCQA Accreditation. Fall 2003 Annual Reports Version 1.1 ...
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... may independently pursue approval from sites that did not opt in after ... not providing all materials required for IRB review in a timely fashion ...
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David A. Weber, Ph.D., FACNP. Chief Officer. Friday, November 12, 2004. FACILITIES AND PERSONNEL ... Oversee compliance with protections established by Common ...
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IRB Approval. The IRB must determine that all of the approval criteria are satisfied in accordance with the Common Rule and FDA regulations: Risks are minimized
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Complete the CITI education course requirement, online. IRB application. Protocol ... CITI not completed. No signature-all personnel listed must sign ...
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PRIM&R and AAMC partner with five other Founding Members. Founding and Incorporated April 2001 ... Association of American Medical Colleges. Association of ...
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in VA-funded multi-site studies by ensuring. Appropriate ethical ... Local VA facilities opt in. 12. VA Central ... of trends in adverse events ...
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Paula Squire Waterman. Office of Research Oversight. ORO. Human. Subject. Protection. Research ... Paula.waterman@va.gov. I will e-mail you a copy of the questionnaire ...
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Office of Research Oversight. The Revised ORO Research Safety ... The responsibilities of ORO are outlined in VA Directive 1058. Office of Research Oversight ...
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Waist Circumference (Gut) Hip Circumference (Butt) Body Mass Index (BMI) Type: Waist Hip Ratio. METABOLIC PREDICTIONS. OF WEIGHT GAIN. Low metabolic rate ...
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When do I need an IND ? FDA Guidance for Industry Investigation New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without ...
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Oversight has focused on procedural compliance as surrogate measures for quality: ... Tuskegee Syphilis Study (1932-1972) Belmont Report (1979) ...
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1999 Kiser testimony to Congress ... What does AAHRPP accredit? Organization. Research Review Unit. Investigator. Human. Research ...
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Compliance with this standard provides public assurances that the rights, safety ... Version Control: only one version is active' at a point in time ...
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The vice-Chairperson must also be approved and officially appointed, in writing, ... The vice-Chairperson may be reappointed without any lapse in time and must ...
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Pt name missing (top of page) Date missing (top of page) Pt initials missing (bottom of page) ... Name of person explaining study missing (last page) Signature ...
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