Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?
Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.
Therapeutic Success or Failure: A Journey, Not Just a Destination
Measuring clinically relevant response requires routine and regular collection of outcomes data.
Interpretation of Regulatory Requirements by Technology Providers: The Case for Electronic Source Data
The authors contrast two views on the regulations concerning electronic source data.