FDA Initiatives and Investigations SCRA701
(Joseph P. Salewski)
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Ethics in Clinical Research SCRA702
(Faith Fitzgerald, MD, MACP)
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Therapeutic Misconceptions ? The Protocol or the Patient: Dilemmas for the Clinical Researcher SCRA703
(Charles Lidz, PhD)
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How Study Site SOPs Ensure Productive Monitoring Visits; How Sponsor Monitoring SOPs Can Ensure GCP Compliance SCRA704
(Gayla B. Herschler, MSN, CCRP, RNC; Elizabeth O. Mitchell, MS)
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Demystifying the IRB; Transitioning from Paper to Electronic IRB Reviews SCRA705
(Suzanne Pursley-Crotteau, PhD, RN; Cheryl Byers, MHA, CIP)
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Impact of a Clinical Research Monitoring Program in an Academic Medical Center; Management of a Multi-Specialty Site ? Some Answers and Many Questions!; Recruiting & Pre Screening SCRA706
(Amy Doville, MBA, CCRP; Patricia D. Kirkpatrick, MSN, CCRP, CCRA, RN; Lisa T. Michelsen, BS, CCRP)
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The Clinical Site?s Perspective; New Strategies for Academic Research Success; Community-Based Recruitment and Research in Rural Neighborhoods SCRA707
(Cheryl Davies, RN; Joanne Goldberg, MSc, BSc, CCRP, pht; Shannon Golden, MA)
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Program Management for the New Millenium; Understanding Knowledge Transfer SCRA708
(Martha F. Nelson, MS, MPA, BSN, RN; Susan I. Devine, CCRP)
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Elements of Informed Consent and the Consent Process; Multimedia Online Informed Consent: Implementation Pathways and Lessons Learned; Informed Consent and Translational Clinical Trials SCRA709
(Jessy K. Thomas, MS, CCRP; Susan Brink, Dr.PH; Jonathan Kimmelman, PhD)
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Statistics - Understanding Protocols and Statistical References SCRA710
(Lynn A. Babin, MSN, BSN, AAS, CCRP, RN)
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Just When You Think You Have Seen It All?..; Monitoring Panel Discussion SCRA711
(Helen R. Darwin, BSc Psych, CCRP; Joseph Salewski, Gayla B. Herschler, MSN, CCRP, RNC, Elizabeth O. Mitchell, MS, Helen R. Darwin, BSc Psych, CCRP)
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Device Basics: An Overview; A Clinician?s Role in Designing and Developing Medical Devices SCRA712
(Eddy Lyons, BSE, CCRP; Robert Corona, DO, CPE, FCAP, FASCP)
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How Much Is Too Much?; Research Nurse Training - Does A Structured Orientation Program Enhance the Confidence Level of a New Clinical Research Nurse?; Site Management Panel SCRA713
(Teresa G. Zais, BS, CCRP; Deborah P. Francis, BSN, CCRP, RN)
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Establishing a Prospective Fiscal Approval Process for Clinical Trials at an Academic Research Facility; NIH Research Grants and the Peer Review Process SCRA714
(René Jooste, M Pharm, CCRP; Ramesh K. Nayak, PhD)
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Unraveling the Complexity of Clinical Research; Phase I Clinical Trials in Healthy Adults SCRA715
(Sandra S. Sinclair, ADN, BS/BA,CCRP, RN; Cynthia S. Way, CIP, CCRP)
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Consent: More Than Just Words; Informed Consent: Comparison of Requirements by U.S. Laws and International Guidelines; Enrollment/Informed Consent Panel SCRA716
(Valerie D. Hatton, BSN, CCRP, RN; Cheryl M. Chanaud, PhD, CCRP, CCRA;
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Research Feasibility: Do You Have an Adequate Patient Population?; Problem Solving - EDC at the Investigative Site; Data Safety Monitoring Boards SCRA717
(Ricky O?Banon, BBA, CCRP, CCRA; Debra Gabrielson, BSN, RN; Rebecca W. Budreau, PharmD, CCRA, RAC)
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Making Life Easier for Monitors: How Data Management Can Help; Monitoring at the Study Site: Case SCRA718
(Karen K. Dhami, BA, MHSc, CCRP; Carolyn E. Rugloski, BA, MS, CCRP)
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Medical Device Development and the CRC - A Sponsor's View; Postmarket Surveillance for Medical Devices: What's It All About' SCRA719
(Carla A. Terrill, ADN, RN; Jason G. Jones, BS, MS, CCRP)
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IND/IDE Overview; Application of Quality System Principles for GCP Compliance SCRA720
(Harvey Arbit, PharmD, MBA, RAC; Lorrie Divers)
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