About Clinical Trials

• Understanding Clinical Trials
• Glossary of Clinical Trials Terms
• Questions about Clinical Trials
• Protocol - A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.
• Protocol Amendments - A written description of a change(s) to or formal clarification of a protocol. These should be version controlled with dates and stored with the protocol.
• Serious Adverse Event (SAE) - Any untoward medical occurrence that:
  Results in death,
  Is life-threatening,
  Requires inpatient hospitalization or prolongation of existing hospitalization,
  Results in persistent or significant disability/incapacity, or
  Is a congenital anomaly/birth defect.
• NINDS Glossary
• Biomedical Informatics Research : how to develop biomedical informatics for supporting clinical research
• A Biomarker is a substance used as an indicator of a biologic state. It is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.