Difference between revisions of "Draft4RCT"

From NCBO Wiki
Jump to navigation Jump to search
m
m
 
(One intermediate revision by the same user not shown)
Line 15: Line 15:
 
**Sponsors
 
**Sponsors
 
*Populations
 
*Populations
<font style="color:blue">**Screened population
+
**<font style="color:blue">Screened population
 
**Recruited population
 
**Recruited population
 
**Eligible population
 
**Eligible population
Line 25: Line 25:
 
*Variables
 
*Variables
 
**Independent variable
 
**Independent variable
<font style="color:blue">***Intervention
+
***<font style="color:blue">Intervention
 
****Procedure
 
****Procedure
 
****Device implantation
 
****Device implantation
Line 36: Line 36:
 
**Dependent variable (responding variable)
 
**Dependent variable (responding variable)
 
***Outcome
 
***Outcome
<font style="color:blue">****Primary outcome
+
****<font style="color:blue">Primary outcome
 
****Secondary outcome
 
****Secondary outcome
 
****Adverse event/Side effect
 
****Adverse event/Side effect
Line 42: Line 42:
 
*Digital and paper artifacts
 
*Digital and paper artifacts
 
*Protocol
 
*Protocol
<font style="color:blue">***Intended protocol
+
**<font style="color:blue">Intended protocol
***Executed protocol</font>
+
**Executed protocol</font>
 
*Protocol application
 
*Protocol application
 
**Assessments
 
**Assessments
Line 68: Line 68:
 
**Ratio
 
**Ratio
 
*Participant characteristic (phenotype)
 
*Participant characteristic (phenotype)
<font style="color:blue">**Baseline characteristic</font>
+
**<font style="color:blue">Baseline characteristic</font>

Latest revision as of 11:27, 26 April 2007

High-Level Concepts

  • Events
  • Periods
    • Study phases
    • Protocol phases
  • Sequence of events
  • Study designs
  • Research types
    • Randomized Clinical Trial
  • Methods
  • Stakeholders
    • Participants
    • Investigators
    • Monitors
    • Sponsors
  • Populations
    • Screened population
    • Recruited population
    • Eligible population
    • Enrolled population
    • Randomized population
    • Analysed population
    • Crossover population
    • Subgroup population
  • Variables
    • Independent variable
      • Intervention
        • Procedure
        • Device implantation
        • Drug treatment
        • Placebo treatment
        • Sham procedure
        • Usual care
        • Counseling
      • Cointervention
    • Dependent variable (responding variable)
      • Outcome
        • Primary outcome
        • Secondary outcome
        • Adverse event/Side effect
        • Ancillary outcome
  • Digital and paper artifacts
  • Protocol
    • Intended protocol
    • Executed protocol
  • Protocol application
    • Assessments
      • Experimental assays
      • Observations
        • Physical exam
      • Interview
      • Self-assessments
    • Data analysis
      • Data partitioning
      • Data transformation
      • Data pooling
      • Data summarization
      • Reliability
      • Correlation
    • Specimen processing
      • Procurement
      • Specimen partitioning/purification
      • Specimen storage
  • Measurement scale
    • Nominal
    • Ordinal
    • Interval
    • Ratio
  • Participant characteristic (phenotype)
    • Baseline characteristic