Glossary

Making up data or results and recording or reporting them.  Fabrication is a form of research misconduct.

Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.  Falsification is a form of research misconduct.

abbreviation for US Food and Drug Administration.

or cleared refers to FDA having issued premarketing approval (PMA) or cleared the device for marketing via a Premarket Notification 510(k).

if the research involves an FDA-regulated test article and the activity involves human participants.

an institution's commitment to DHHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance.

a developing human organism from the time of implantation until delivery; generally, refers to later phases of development.

financial information maintained to support accurate billing of clinical services associated with a research study.

an agency, organization, company, or person that pays for the trial.

compensation of any type (e.g. cash, cash equivalents, office or medical supplies, educational stipends, gift certificates, travel cost in excess of normal reimbursement costs, or anything else of value) to an individual made in exchange for referral or recruitment of a participant to a research study. This does not include compensation for services rendered which include screening and referral activity unrelated to whether the participant ultimately enrolls in or completes the research study.

noncompliance that is supported by a preponderance of evidence. A finding of noncompliance may exist because there is clear evidence, an admission supported by evidence, or an investigation into an allegation has determined the allegation to be supported by a preponderance of evidence.

applicable to interventional study, indicates the participant has completed the intervention being tested as planned and is continuing with non-interventional procedures or other study interaction(s).

Complete - is a water in oil emulsion containing dried Mycobacterium butyricum which is used to enhance antigenicity and a greater immune response. (may be abbreviated as either: CFA or FCA)