A customizable software system used by biotechnology and pharmaceutical industries, specifically in clinical research institutions, to electronically manage large amounts of data involved with the operation of a clinical trial. The system maintains and manages all planning, preparation, performance, and reporting completed during clinical trials. It also maintains up-to-date participant contact information, tracking deadlines and milestones.
A plan that documents the processes for handling the flow of data from collection through analysis. Software and hardware systems along with quality control and validation of these systems, as relevant are described
A product's ability to produce beneficial effects on the duration or course of a disease. Efficacy is measured by evaluating the clinical and statistical results of clinical tests.
Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.
A medical professional, usually a physician, but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his or her site.
A designation of the FDA to indicate a therapy developed to treat a rare disease (one which afflicts a U.S. population of less than 200,000 people). Because there are few financial incentives for drug companies to develop therapies for diseases that afflict so few people, the U.S. government offers additional incentives to drug companies (i.e. tax advantages and extended marketing exclusivity) that develop these drugs.
The person who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study).
The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
Individual, company, institution or organization taking responsibility for initiation, management and financing of a clinical trial.