Textbook of clinical trials: Difference between revisions
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==Study Tools== | ==Study Tools== | ||
[[Abbreviations]] | [[Glomerular filtration rate|GFR calculation]] | [[TIMI Risk Score|TIMI risk score]] | [[The GRACE risk score|GRACE risk score]] | [[TIMI bleeding criteria]] | [[GUSTO bleeding criteria]] | [[CURE bleeding criteria]] | [[ACUITY HORIZONS bleeding criteria]] | [[STEEPLE bleeding criteria]] | [[PLATO bleeding criteria]] | [[GRACE bleeding criteria]] | [[Hy's law]]| [[Creatine kinase|D/D of CK elevation]] | [[Anemia|D/D of Anemia]] | | [[Abbreviations]] | [[Glomerular filtration rate|GFR calculation]] | [[TIMI Risk Score|TIMI risk score]] | [[The GRACE risk score|GRACE risk score]] | [[TIMI bleeding criteria]] | [[GUSTO bleeding criteria]] | [[CURE bleeding criteria]] | [[ACUITY HORIZONS bleeding criteria]] | [[STEEPLE bleeding criteria]] | [[PLATO bleeding criteria]] | [[GRACE bleeding criteria]] | [[Hy's law]] | [[Creatine kinase|D/D of CK elevation]] | [[Anemia|D/D of Anemia]] | | ||
Revision as of 03:56, 28 October 2019
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
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
Abbreviations | GFR calculation | TIMI risk score | GRACE risk score | TIMI bleeding criteria | GUSTO bleeding criteria | CURE bleeding criteria | ACUITY HORIZONS bleeding criteria | STEEPLE bleeding criteria | PLATO bleeding criteria | GRACE bleeding criteria | Hy's law | D/D of CK elevation | D/D of Anemia |