Box 5.1Terms Commonly Used in This Chapter

510(k) Notification: A marketing submission to FDA providing evidence that a medical device is “substantially equivalent” to a currently marketed device. A 510(k) clearance, not an approval, is granted for marketing these devices. Medical devices requiring a 510(k) clearance rather than a Premarket Approval (PMA) are typically lower-risk medical devices and devices that are substantially equivalent to devices that have been on the market since 1976 (pre-amendment devices). These devices also do not require an investigational device exemption for conducting clinical studies.

Audit: A systematic and independent examination of study-related activities and documents to determine whether those activities were conducted and the data recorded, analyzed, and accurately reported according to the protocol sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.

Biologic License Application (BLA): An FDA submission for marketing approval of specified biotechnology products such as products manufactured by recombinant DNA technology and monoclonal antibody products. A BLA is submitted to FDA's Center for Biologics Evaluation and Research (CBER).

Common Rule: The colloquial name for 45 CFR 46, Subpart A, the Federal Policy for the Protection of Human Subjects. This regulation consolidates requirements for IRB review and informed consent to participate in human subject research. It applies to any DHHS-funded research conducted on human subjects as well as that funded by 15 other agencies. FDA has promulgated its own regulations (21 CFR Parts 50 and 56) for FDA-regulated research, which closely mirror the Common Rule. Both sets of regulations apply when research is FDA-regulated and federally funded (wholly or partially).

Continuing Review of Research: The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.

Data and Safety Monitoring Board/Data Monitoring Committee (DSMB/DMC): An independent data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical study, the safety data, and the critical efficacy endpoints, and to advise the sponsor whether to continue, modify, or stop a study. The terms Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee, and Independent Data Monitoring Committee are synonymous.


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.

Federalwide Assurances (FWA): Under federal regulations, an approved Assurance of Compliance must be in place for any institution that is engaged in federally funded human subject research. This written Assurance of Compliance documents the research institution's understanding of and commitment to comply with federal standards for the protection of the rights and welfare of the subjects enrolled in that research. For research funded by DHHS, these standards are found in 45 CFR Part 46. Assurances are awarded and monitored by the DHHS Office for Human Research Protections (OHRP). In December 2000, OHRP issued a plan to require each institution engaged in research activities, either on its own or as a subcontractor, to hold its own FWA. A single FWA would cover all research conducted at that institution. The FWA would be renewed every three years, and compliance would be monitored by OHRP. A revised version of the FWA was issued in March 2002.

Form FDA 483: Written documents describing objectionable practices observed during an FDA inspection of a sponsor, IRB, or research site.

Good Clinical Practice (GCP): A standard established by the International Conference on Harmonisation (ICH) for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical studies that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of study subjects are protected. (E6 is the relevant guideline.)

Investigational New Drug Application (IND): Refers to the regulations in 21 CFR 312. An IND that is in effect means that the IRB and FDA have reviewed the sponsor's clinical study application, all the requirements under 21 CFR 312 are met, and an investigational drug or biologic can be distributed to investigators.

Monitor or Monitoring: The act of overseeing the progress of a clinical study and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and applicable regulatory requirement(s).

New Drug Application (NDA): An FDA submission for marketing approval of new drugs. An NDA is submitted to FDA's Center for Drug Evaluation and Research (CDER).

Premarket Approval (PMA): An FDA submission for marketing approval of new medical devices that impart significant risk. A PMA is submitted to FDA's Center for Devices and Radiological Health.

Product License Application (PLA): An FDA submission for marketing approval of all other CBER-regulated products except those that require a BLA. This includes but is not limited to blood products, vaccines, and allergenic extracts.

Standard Operating Procedure (SOP): A document that specifies all the operational steps, acceptance criteria, personnel responsibilities, and materials required to accomplish a task.

NOTE:Most definitions are adapted from the International Conference on Harmonisation; Good Clinical Practice: Consolidated Guideline (E6) Glossary (ICH, 1996).

From: 5, Improving Protection Through Oversight and Data and Safety Monitoring

Cover of Responsible Research
Responsible Research: A Systems Approach to Protecting Research Participants.
Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Participants; Federman DD, Hanna KE, Rodriguez LL, editors.
Washington (DC): National Academies Press (US); 2002.
Copyright © 2003, National Academy of Sciences.

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