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Research 101, 102, and 103

BASIC RESEARCH TRAINING

These courses were designed for new investigators, research staff and coordinators, and anyone who wants to learn more about research study conduct (Research 101) or research study management (Research 102 and 103).


Research 101

Research History and Background, Evolution of Regulations and Guidance

Janie Gardner, MS, CCRP, CIM

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Phases of Clinical Research and Study Types

Janie Gardner, MS, CCRP, CIM

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Good Clinical Practice, ICH Guidelines, Compliance, FDA Regulations

Derita Bran, MSN, RN, CCRC

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Standard Operating Procedures

Marie Jackson, PhD, MBA

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Role and Responsibilities of the IRB, Sponsor, CRO, Principal Investigators, and Key Study Personnel

Derita Bran, MSN, RN, CCRC

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Informed Consent / Assent and Documentation of the Informed Consent Process

Margaret Lynn, LMSW, RDN, CCRP, CIP

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Research 102

Effective Communication, Leadership and Professionalism

Sally Badoud, MS

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Subject Recruitment

Margaret Knack, RN, MS, CCRP

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FDA Audits and Common Findings

Jennifer Burgess, MSÌý

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Creating Site Worksheets/Visit Checklists

Derita Bran, MSN, RN, CCRC

Carol Hendrix, MSN, RN, CCRC

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Confidentiality/Privacy/HIPAA

Kim Prachniak, MS, CIPÌý

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Advanced Consent Issues

Margaret Lynn, LMSW, RDN, CCRP, CIPÌý

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Research 103

How to Develop Power Point Presentations and Other Effective Communication ToolsÌý

Sally Badoud, MSÌý

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Research Contracts and AgreementsÌý

Sarah J. White, MA, EdM Ìý

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Using the Research Enterprise Data Warehouse database (EDW) and TriNetX for Subject Recruitment and Using REDCap for Data CaptureÌý

Parya Zareie, MS Ìý
Lokesh Chinthala, MS Ìý

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Download Part 2 Powerpoint

Protocol and Study Measures Training – The Importance of Accuracy and ConsistencyÌý

Misty Thompson, PhD, CCRP Ìý

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Scientific Integrity and Preventing Research MisconductÌý

Mark A. Miller, PhDÌý

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