The process of applying statistical techniques to describe, summarize, and compare data to extract useful information and facilitate conclusions.
A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial.
The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.
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.
The section of a protocol that describes the steps to identify physical, social, or psychological occurrences that may result from participation in the research study and explains in detail how such occurrences will be handled and reported. A DSMP describes the timing, tools and/or method(s) for monitoring and evaluation, procedures for treatment or resolution (including circumstances which would result in halting or terminating research), procedures for and timing of reports to oversight bodies, and description of oversight bodies involved with the study (e.g. FDA, IRB, or Data and Safety Monitoring Board). A study does not need to have a Data and Safety Monitoring Board to have a DSMP.
A Data Use Agreement (DUA) is a contractual document used for the transfer of data that has been developed , where the data is nonpublic or is otherwise subject to some restrictions on its use. Often this data is a necessary component of a research project and it may or may not be human subject data from a clinical trial, or limited data set information as defined in HIPAA. Universities will want to ensure that DUA terms protect confidentiality when necessary, but permit appropriate publication and sharing of research results in accordance with institution policies, applicable laws and regulations, and federal requirements. DUAs are similar to confidentiality agreements.
Health information from which a covered entity has removed all 18 HIPAA identifiers as long as the covered entity has no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual to whom the information applies.
Giving subjects previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information).
A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It has been revised several times, most recently in October, 2000. Link: Declaration of Helsinki
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is
An investigational medical device that does not present significant risk to the patient.
An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject.
Trials that are conducted to find better diagnostic tests/procedures for identifying a particular disease or condition. Diagnostic trials enroll people who have signs or symptoms of a disease or condition being studied.
A product meant for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet. A "dietary ingredient" may be one, or any combination, of the following substances:
NOTE: A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with Dietary Supplement Health and Education Act it is not a drug solely because the label or the labeling contains such a statement.
The release, transfer, provision of access to, or divulging in any other manner of information outside the Covered Entity holding the information.
Any article (other than food)
