Glossary
Request for Amendment. CTEP distributes these for active studies using CTEP-supplied agents. If a rapid turn-around is requested, it is called an RRA (Request for Rapid Amendment).
Process by which patients are placed into one of multiple treatment arms by an automated system
The decision by a group, institution, or the NCI to re-start patient entry onto a study that was previously temporarily closed (See below for definition of temporarily closed)
Response Evaluation Criteria in Solid Tumors. A set of published rules that define when cancer patients respond, stabilize, and progress during treatments.
An institution or group that assumes a broad range of responsibilities and functions for the support of clinical trials conducted under its name. It supports the investigator in developing, organizing, implementing, and analyzing clinical trials. It assumes responsibility for the quality of the research, both in concept and execution, and has an important role in assuring patient safety.
Administrative changes to a protocol that do not affect patient care or patient treatment, or a scientific change that does not substantively increase the patient’s risk/benefit ratio. Examples: Change of study coordinator, addition or deletion of a participating institution, or correction of an error. The revision date appears in the upper right hand corner of revised protocol pages.
Request for Applications. NCI sends out a request for studies dealing with their priority research areas. NCI sets aside money funding for these projects, should high quality applications get approved.