A study designed to obtain additional safety and/or efficacy data. These studies may be clinical trials or non-interventional, and are often conducted as a post marketing (Phase 4) activity.
Participant in a study. See “Human Subject.”
Helps design and conduct investigation at a study site.
A primary or secondary outcome used to judge the effectiveness or safety of a treatment.
The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of subjects studied and observations made, as well as the magnitude of differences observed.
The currently accepted treatment or intervention considered to be effective in the treatment of a specific disease or condition.
Official, detailed, written instructions for the management of clinical trials. SOPs ensure that all the functions and activities of a clinical trial are carried out in a consistent and efficient manner.
Individual, company, institution or organization taking responsibility for initiation, management and financing of study.
Location where information is first recorded including original documents, data and records.
All information contained in original records and certified copies of results, observations or other facets required for the reconstruction and evaluation of the study that is contained in source documents.