Textbook of clinical trials
Ethical Issues
Investigational Review Board (IRB)
HIPAA deidentification and reidentification of patients and patient privacy
Regulatory Issues and Pathways in Clinical Trials
The 1572 form and investigator responsibilities
Investigational new drug (IND) application
Investigational new drug or device exemption
Designing Clinical Trials
Randomized controlled trials versus observational studies
Pharmacokinetic (PK) and pharmcodynamic (PD) assessment
Advancing from phase 2 to a phase 3 trial
Parallel versus dose escalation studies
Inclusion and exclusion criteria
Secondary endpoints and exploratory endpoints
Sample size and power calculations
Abbreviations used in clinical trials
Operationalizing Clinical Trials
Nurse coordinator clinical research associate role
Recruitment of study participants
Clinical event committee or event adjudication committee (CEC)
Adverse events, serious adverse events and serious unexpected events
Data safety monitoring board (DSMB)
Storage and handling of the investigational product
Data management and designing an electronic data capture form
Study completion and close out
Statistical Analysis of Clinical Trials
Intent to treat versus modified intent to treat versus as treated
Student's t tests and analysis of variance (ANOVA)
Chi square analysis and Fisher's exact test
Subgroup and interaction analyses
Quality-adjusted life year analyses
Study Tools
Bleeding: ACUITY HORIZONS bleeding criteria ● Bleeding Academic Research Consortium ● CURE bleeding criteria ● GRACE bleeding criteria ● GUSTO bleeding criteria ● PLATO bleeding criteria ● STEEPLE bleeding criteria ● TIMI bleeding criteria
Calculators: GFR calculation ● Wells score calculation ● Caprini score calculation ● CHA2DS2-VASc score calculation ● DAPT score calculation ● TIMI risk score calculation
Differential Diagnosis: D/D of Anemia ● D/D of CK elevation ● D/D of Chest Pain
Other: Abbreviations ● Hy's law
Risk Score: GRACE risk score ● TIMI risk score
Course Slides
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