A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally accepta [..]

A trial results database provides the results of completed studies, and should be accompanied by methodological details to place the results in context. The results may or may not have been peer revie [..]

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponso [..]

A direct benefit to a person’s health signifies not only treatment to cure the patient but also treatment that may alleviate his/her suffering thus improving his/her quality of life.

All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, an [..]

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and [..]

Which refers to the magnitude of a bad outcome.

The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disea [..]

In the context of research, an incapable adult is an adult who cannot consent to research alone.