A determination by the convened IRB to permanently halt some or all previously approved research activities including, but not limited to, enrollment of new subjects. NOTE: Terminations of IRB approval apply to a cessation of research projects or activities due to concerns about the safety, rights, or welfare of human research subjects or others. They do not include interruptions in human research resulting solely from the expiration of the IRB approval period.
Any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n).
Potential research participants who are also patients believe that a clinical trial proposed by their health care provider will provide a therapeutic benefit to them, even after being told that there is no assured benefit.
Specimen collection banks, whether they are described as "banks" or not, are many and varied. They cover the spectrum from individual clinicians' research specimen collections, (often gathered with no specific project in mind) to institutional "Tissue Banks" (such as cancer center shared resource banks) to multi-center, industry-sponsored drug trials which usually collect at least some blood or tissue for unspecified future research.
A detrimental effect produced by a drug or condition.
In word processing, track changes is an editing command that is commonly used when you create an original document and make changes and want to keep track of the changes that are made to that original document. It is also a useful tool for collaborating on a document, as it allows multiple users to make revisions without losing the context of the original document. Changes to text and formatting are noted in a number of different ways, depending on the word processing software you use. Tracking changes allows the IRB staff and board members to clearly see what changes, modifications, updates, and additions have been made to study documents.
Transitional device: a device subject to section 520(l) of the FD&C Act and which FDA previously regulated as a new drug or an antibiotic drug before May 28, 1976.
