Global Trial Set-up - Monitoring Selection & Qualification of Sites: Selection of Countries and Trial Sites for a Global Study - Feasibility, Evaluation, and Approval; Global Trial Set-up - Regulatory Issues of a Global Trial: Country-Specific Submissions and Approvals SCRA721
(Paula Fischthal, MA; Anatoly V. Gorkoun, MD, PhD)
|
|
|
"When a Cough is Just a Cough" - The Trouble with AEs; Adverse Event Reporting in Investigator Driven Studies SCRA722
(Herschel R. Lessin, MD; Marjorie McLimont, BSc, MSc)
|
|
|
EDICT - Eliminating Disparities in Clinical Trials Project - The History of Underprivileged Groups in Human Subjects Research in America; EDICT - How Policy Discussions Impact Regulations; EDICT - How Policy Discussions Impact Regulations SCRA723
(Daniel Bustillos, JD, PHD; Armin D. Weinberg, PhD; Larry E. Laufman, EdD)
|
|
|
Compliant Electronic Data for Clinical Research; Regulations/Determining If Your Study is Compliant SCRA724
(Patricia L. Rossman, BS, MT, SBB, CSQE; Stephen D. Litavecz, MBA, CCRP)
|
|
|
Minority Issues - Engaging African American Communities in Research and Interventions SCRA725
(Angela Ford, PhD, Sandra Crouse Quinn, PhD, Stephen B. Thomas, PhD, Yvonne Durham, John Potter)
|
|
|
Monitoring Investigator-Initiated Trials: The Role of the Institution; Monitoring Investigator-Initiated Trials: The Role of the IRB; Monitoring Investigator-Initiated Trials: The Role of the Project Manager in Government Network Sponsored Trials SCRA726
(Daniel E. Redline, BA, COA, CCRC, CCRP; Anthony Perez, JD; Nariman Nasser, BS, CCRP)
|
|
|
Compliance Issues and Regulatory Pursuit; Informed Consent in Device Trials SCRA727
(Sonali P. Gunawardhana, JD, LLM, MPH; Connie B. Cross, BS, CCRP)
|
|
|
Responsible Communication for Clinical Research Professionals; Developing an Internal Quality Improvement Program at the Site Level (a.k.a. Quality Assurance - A Necessary Evil or a Quality Experience?) SCRA728
(Cathy Anderson, BPharm, RPh; Pamela J. DeWeese, BA, MAT, CCRP)
|
|
|
Global Trial Set-up - Monitoring Logistics: Strategies for an International Multicenter Study Including Visit Planning, Expectations, Training and Tools for the Initiation Visit; Capacity Building: Preparing International Researchers to Develop and Conduct Future Studies SCRA729
(Marina Kiseleva, MD; Kevin Wilson, MS, BS, MCP)
|
|
|
Strategies for Success: The Restructuring and Development of a Cancer Clinical Research Unit SCRA730
(Rachel M. Syme, PhD)
|
|
|
Informed Consent - Strategies for Handling Difficult Issues in Pediatric Trials; Strategies for Handling Difficult Issues in Pediatric Trials SCRA731
(Brian Berendts, BSN, RN, CCRC; Kathleen Harden, BSN, RN, AE-C, CCRC)
|
|
|
Developing Clinical Research Budgets; Tools and Resources for Charging Clinical Trials Tests and Procedures; Clinical Trial Budgeting SCRA732
(Lisa A. Benson, BS, CCRP; Martha F. Nelson, MS, MPA, BSN, RN; Andrew T. Snyder, MBA, FACMPE, PMP)
|
|
|
One Way to Implement Community Consultation When Using Emergency Exception to Informed Consent; What They Don?t Understand: Research, Recruitment, and Consent of the Unidentified Decisionally Impaired Participant SCRA733
(Paula Knudson; Margaret Almeida, MBA, BSN, BS, RN, BC)
|
|
|
Device Monitoring; Medical Device Monitoring: The Statistician?s Perspective SCRA734
(Kathi Goodwin Durdon, BA, MA, CCRP; Christopher Lyle, MS, BA)
|
|
|
Device Reimbursement; Lessons Learned from FDA Audits SCRA735
(Mary T. Walchak, MS, MBA; Roseanne Schott, MBA, BSN, RN, CCRP)
|
|
|
Where the FDA Regulations End and ICH GCP Begins - The Differences and Similarities Between the Two; Post Approval Monitoring: A Comprehensive Human Subject Protection Program SCRA736
(Paul R. Below, MA, CCRA; Marti Benedict, BSN, RN)
|
|
|
The Utilization of Monitoring Benchmarks for Site Performance Evaluation in Project Phidisa SCRA737
(Laura A. McNay, BS, MS, Shelly Simpson, MS, Judy Zuckerman, BSN, CCRC, RN, Anita Lessing, Mpharm, Lotty Ledwaba, MD)
|
|
|
Lynch Syndrome (Hereditary Nonpolyposis Colorectal Cancer Syndrome) - Sequence Mutation versus Hypermethylation; Oncotype DX Assay: Its Role in Breast Cancer Management SCRA738
(Patricia J. Gambol, MSN, APNG, RN; Gary Palmer, MD, MBA, MPH)
|
|
|
Unique Issues in Pediatric Trials: Informed Consent, Child Advocacy, and Risk Determination SCRA739
(Donna Sylvester, BSN, MHA; Tonia Morrison, BA, CCRC)
|
|
|
Budgets and Contracts; Research Financial Compliance: Where to Begin SCRA740
(Patricia D. Kirkpatrick, MSN, CCRP, CCRA, RN; Judi Kulko, MSN, RN)
|
|
|
