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Library Entry
seeking proposal for onsite IRB member training, due 1/31/2015 for April/May 2015 training

A regional volunteer IRB is seeking onsite/inperson training for 12 member IRB similar to the PRIM& R IRB 250 program, 2-3 hour program + webinar. funding for training is being provided through a local grant /agency #Universities #HealthCare #Research #Consulting #Physicians ...

IRB250_Modules[1].pdf




Library Entry
Clinical Research

All documents prtaining to Clinical trials #Articles #Research #Physicians #HealthCare

International_Clinical_Trials_ASENT regulatory affairs.pdf


Blog Entry
Policy Management: The Five Steps to Success

Let’s face it: policy management is like eating yourvegetables. It’s necessary and we know we have todeal with it every day to stay healthy. But in reality, quality policy creation, dissemination, and continuous management are crucial toany organization. Every internal document has the same...

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Library Entry
MLN article #SE0822

Attached are both the original SE0822 and the revised SE0822 MLN Matters articles. The article was revised on 1/7/09. #RegulationsandLaws #HealthCare #Government #government #LawFirms #research #Consulting #Research

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Library Entry
Quality Improvement or Human Subjects Research? A Glimpse at the Gray Areas

Topics: I. Why Should I Care About The Gray Areas?II. The Johns Hopkins vs. OHRP SagaIII. Key QuestionIV. Regulation of ResearchA. Office for Human Research Protections (OHRP)B. ResearchC. Human SubjectD. “Research” Within HIPAAE. The Common Rule: 45 C.F.R. Part 46F. IRB Oversight FunctionsV. ...

Quality_Improvement_Human_Subjects.pdf


Library Entry
Medical and Research Billing – The Fundamental

Agenda- Overview of Billing Requirements- Charge Description Master (CDM)- MS-DRG and Documentation- Physician at Teaching Hospitals (PATH)- The Rules- Surgical Presence- Provider vs. Non-Provider Based Clinics- Challenges in Outpatient Billing- Infusion Therapy- Observation Services- Clinical...

Medical_and_Reserach_Billing.pdf


Library Entry
Legal Issues in Clinical Research: What You Need to Know

Agenda: Sources of RegulationFocus on Reimbursement of Clinical Trial CostsUpdate on Medicare CoverageEmerging Issues in Medicaid CoverageOther Legal Issues and Practical Approaches #Research #research

Legal_Considerations_Clinical_Research.pdf