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Clinical Research Ethics and Roles and Responsibilities of Research Personnel
Topics include:
Tuskegee Study; Belmont Report; Helsinki Declaration
IRBs / Ethical boards / DSMBs
Vulnerable populations (i.e. children, mentally challenged)
Informed consent
Subject recruitment & retention
Examiner training & calibration
Assuring integrity of data
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Final Pr. ID: 0004
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Core Clinical Research and Statistical Concepts
Specific topics include:
Defining the research question
Causation vs. association
Sources of error in clinical research
Multiple outcomes: primary and secondary outcome measures
Basics and benefits of clinical trials/intervention studies
Study Populations
Randomization
Masking / Blinding - whom and why
Intention To Treat (ITT) & per-protocol statistical analyses
Use of biomarkers and surrogate measures
Superiority, equivalence & non-inferiority Introduction to multivariable statistical modeling
Linear regression
Regression of dichotomies and counts
Survival regression
Management of simple confounding and effect modification via regression models
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Final Pr. ID: 0002
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Definitions & Types of Clinical Research, Funding Opportunities, and Publication of Research
Topics include:
Cross-sectional, retrospective, prospective Studies
Observational studies: case control, cohort Studies
Interventional studies: clinical trials
Study protocol - purpose & contents
Data coordinating centers
Code of Federal Regulations (CFR)
Good Clinical Practice (GCP) Regulations / Guidelines
Complying with GCP and other FDA requirements
Certification of Research Personnel
Publication of Results
Writing and submitting abstracts & manuscripts Authorship
NIH/NIDCR Research Support
Grants/ Contracts/ Co-operative agreements
NIH alphabet soup - RFAs, U01s, PA, PARs, PAS etc.
Peer review, funding decisions, NIH oversight
Opportunities for further
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Final Pr. ID: 0001
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FDA Regulations Relevant to Oral Health Research and Conducting studies for industry
Topics include:
Definitions: Drugs / Devices / Combination Products / Cosmetics
Prescription drugs
Non-prescription (OTC) drugs
Enforcement Activities
Getting started with industry: Establishing the relationship
Maintaining confidentiality
Protecting intellectual property
Negotiating contracts
Meeting agreed upon target dates
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Final Pr. ID: 0005
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Prominent Design and Statistical Issues in Clinical Research
Specific Topics include:
Data analysis
Hypothesis testing
Statistical significance: P-value + 95% CI
Statistical power
Overview of statistical tests for 2-group comparisons
Misuses of the p-value Prominent Design Issues in Clinical Research
Dealing with the complexity of oral health data
Missing data, Correlated or clustered data (sites vs. subjects)
Models for correlated or clustered data
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Final Pr. ID: 0003
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