Single-blind research design – A study in which one party, either the researcher or the participant, does not know what medications or interventions the participant is taking; Also called a single mask study. (3) Is an employee responsible for receiving medical complaints or adverse event reports? or (i) is primarily engaged in conducting medical diagnostic tests on patients, For complete legal definitions and more information on the meaning of the applicable clinical trial, see Developing Responsible Party Definitions and Applicable Clinical Trial (PDF). This glossary will help you understand commonly used words and phrases on ClinicalTrials.gov. Many of these words are also used by clinical researchers and others in the same or similar way. However, the following definitions are only intended to explain the content of ClinicalTrials.gov. (1) If you are a facility for device users, you will be deemed to have “become aware” when medical personnel as defined in this section who are employed by your facility or otherwise officially associated with your facility receive information about a reportable event. National Library of Medicine – The largest biomedical library in the world, the National Library of Medicine (NLM) maintains and provides an extensive print collection and produces electronic information resources on a variety of topics that are searched billions of times each year by millions of people around the world. It also supports and conducts research, development and training in biomedical informatics and health information technology. In addition, the library coordinates a 6,000-member national network of medical libraries that promotes and makes available health information in communities across the United States. (a) definitions. For the purposes of this section, the following definitions apply: The voluntary submission of information for a clinical trial under 42 CFR 11.60 may trigger the requirement to submit information for other clinical trials (i.e., “triggered” studies) if certain conditions of the regulations are met.
The trigger requirements of 42 CFR 11.60(a)(2)(ii) or 11.60(b)(2)(ii) apply if the voluntarily submitted study (either a voluntary submission of a “non-ACT” clinical trial or a voluntary submission of a “pre-FDAAA applicable clinical trial (ACT)”) reviews the use of a drug, biologic, or device for which the manufacturer (who is also the responsible party to the study) on or after September 27. Pre-market application or notification submitted to the FDA. 2007, for approval, approval or authorization of use studied in the clinical trial. Initiated studies that require clinical trial information are pre-FDAAA ACTs (i.e., ACTs that began on or before September 27, 2007 and have a primary completion date prior to September 26, 2007). December 2007), which (1) address the same use of the drug, biologic, or device product in the FDA application or pre-market notification, and (2) must be submitted to the FDA in a pre-market application or notification for approval, approval, or market authorization of the drug, of the biological or device product studied in the clinical trial. A study that does not meet the definition of an ACT under 42 CFR 11.10(a) (for example, a Phase 1 clinical trial of a drug or biologic, a small product feasibility study, or an observational study) would not be considered a initiated study under 42 CFR 11.60. Institutional Review Panel – For the purposes of Code of Federal Regulations, Title 21 Part 56, means any body, committee or other group officially designated by an institution to review, authorize and periodically review biomedical research involving humans. The main purpose of such an examination is to ensure the protection of the rights and well-being of human subjects. Privacy is an important part of clinical research and ensures that personal data is only seen by those authorized to have access to it. It also means that the personal identity and all medical information of clinical trial participants is known only to the patient and researchers. The results of a study are usually presented only in terms of trends or overall results and are not mentioned to specific participants.
Many radiation-emitting equipment is subject to Section 510(k) of the FD&C Act and some are subject to Section 515 of the FD&C Act. If the product is a medical device intended to assist patients in treating or diagnosing a disease or condition that does not affect or manifest more than 8,000 people in the United States per year, it may meet the requirements of a compassionate device under Section 520(m) of the FD&C Act. FDA regulations in 21 CFR Part 892 describe the legal status (i.e., “classification”) of specific radiological devices, including diagnostic and therapeutic equipment. For example, magnetic resonance diagnostic devices and medical load particle radiation therapy systems are designated as Class II devices (as defined in 21 CFR 860.3(c)(2)) in 21 CFR 892.1000 and 21 CFR 892.5050, respectively, and are subject to Section 510(k) of the FD&C Act. In addition, a single X-ray device classified as a Class III “high-risk” device or classified by the FDA as not substantially equivalent (NSE) to an existing Class I, II, or III device must generally be approved by the FDA under Section 515 of the FD&C Act before being marketed. The final rule clarifies that the use of a drug, biologic, or expanded access (EA) is not considered an “applicable clinical trial” (ACT) as defined in 42 CFR 11.10 (81 FR 65009-10).