CTO workshop preparation

I thought it would be useful to outline the items we are considering  
as part of DSE, namely...

1) Electronic Clinical Data Capture, addressing elaborate and  
adaptive study designs
2) Biomarker and genetic testing and diagnostics
3) Enhanced Organization of data to support deeper mining and re-use  
of data, i.e, mechanisms of action, toxicity analyses

In addition, looking at what is on the CTO wiki, I felt it might be  
useful to provide an outline for the essential components of a  
clinical trial.. please adjust as you see fit...

Clinical Trial Components

Study Goals
NCE Therapeutic Value
Clinical Stage
Safety
POC/Efficacy
Study Design
Arms
Dosing
Size
Group Pre-selection
Treatment Termination plan
Adaptive Model (if used)
Recruitment Plan
Study Recruitment
Clinical Centers
Subject classification and segmentation
Criteria
Release Forms
Study Execution
Visits
Drug and Vehicle treatment
Observations / Tests
                                                      i.     Vital Signs

                                                       ii.     Assays

                                                         iii.      
Biomarker sampling

Treatment Termination
Follow up visits
Database Locking
SOP
Compliance
QA
Admin decision
Analysis
Statistical analyses
Expert inspection
Interpretation
Decision Point
Report generation
Submission
Plan
Document compilation
Inspection
Reviews
Decision Point
Final review
Final Decision Point
Submission

See you soon!

Eric