Regulatory Documentation in Clinical Trials
A clinical trial is only as good as the records kept by investigators and their research teams. Research sponsors tend to be very specific in outlining their expectations for records…
Tags: Clinical Trials
Public Comment Sought on Proposed Changes to Research Regulations
The U.S. Department of Health and Human Subjects (HHS) recently issued a press release outlining proposed changes to the “Common Rule”, which has gone essentially unrevised since its adoption in…
Best Practices for Clinical Trials Procedure Matrix
The Clinical Trials module (CT) provides two options for setting up a detailed clinical trial plan, which in InfoEd’s terminology is called the Procedure Matrix. Clients not using the Financials…