Clinical leisure

6. A temporary locked state for data that allows the generation of queries but does not allow a change to data points.
7. A clinical trial that is conducted according to a single protocol but at more than one site and therefore is carried out by more than one investigator.
9. An investigational or marketed product (i.e., active control) or placebo used as a reference in a clinical trial.
12. The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments. Used to reduce bias.
13. The physical and mental integrity of the subjects participating in a clinical trial.

1. A procedure in which one or more parties to the trial is kept unaware of the treatment assignment(s).
2. A particular area (as of a record in a database) in which the same type of information is regularly recorded.
3. The act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
4. Inconsistency in two or more data points collected in a clinical trial that must be addressed prior to database lock.
5. medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products.
8. Overall outcome that the protocol is designed to evaluate. Common it is severe toxicity, disease progression, or death.
10. The affirmative decision of the institutional review board (IRB) that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
11. Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements.