Describes a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel design involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group who receive drug B.
A natural or adoptive parent whose parental rights over the child have not been terminated by the Courts
The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].
See "Consent Document(s)"
The agreement of parents to the participation of their child in research.
See "Clinical Trial"
A placebo is an inactive pill, liquid, powder, or other intervention that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.
A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices (For more information, visit the FDA's Pre-Market Approval page).
Refers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before human trials.
For purposes of OHRP policy, the period of time from implantation until delivery.
Refers to trials that find improved ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle interventions.
Primary data collection involves direct contact with, or observation of, one or more people for the purpose of collecting data from or about them.
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 person who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study).
An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution. The definition of "minimal risk" for research involving prisoners differs somewhat from that given for non-institutionalized adults.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public.
The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic.
Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.
Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
Information about the past, present, or future physical or mental health of an individual that identifies or could be used to identify the individual and is created or received by a Covered Entity. (45 CFR 160.301, 164.501; information about the provision of health care and payment for health care is included; some educational and employment records are excluded.)
Individually identifiable health information that is covered under HIPAA consisting of the following:
A document that describes the objective(s), design, methodology, statistical consideration, and organization of a trial.
A written description of a change(s) to or formal clarification of a protocol.
Internal document created as part of the ongoing quality control process summarizing compliance with the protocol and listing protocol deviations and/or violations.
Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution's commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include:
The Protocol Review and Monitoring Committee (PRMC) was formed in 1993 to comply with National Cancer Institute guidelines in establishing a scientific review and monitoring system of cancer studies - it is a mechanism for quality assurance. The PRMC membership includes faculty, statisticians, pharmacy, imaging, patient advocate, research nurse and other ad hoc reviewers from various disciplines within the Health Sciences. The PRMC reviews cancer-related protocols for scientific merit and progress, including participant accrual. It also prioritizes cancer protocols that may compete for the same patient population. Its function is complementary to that of the Institutional Review Board, which focuses on the protection of human subjects in research. If a study is designed to involve cancer patients, it must receive PRMC approval before it can be IRB approved. If a study includes cancer patients by default (as part of a broader patient population) and not by study design, it doesn't need PRMC review.
