Please Note: The definitions provided in this section are directed towards potential research participants, and most of the descriptions are not intended to be comprehensive and complete. For individuals interested in more complete descriptions and definitions, please see Good Clinical Practice
Adverse Event(AE): Any health-related problem experienced by a research participant during the course of the research study. The AE does not have to be (and usually is not) related to the investigational medicine.
Blinding: This is the concealment of medication/treatment identity with the objective of avoiding unintentional bias by either the research subject and/or staff in treatment outcomes. Single blind means that the research subject is unaware of treatment identity, but the research staff knows the treatment. Double blind means that neither the research subject or the research staff know the treatment identity.
Clinical Research Coordinator (CRC): At SEC Clinical Research, these are mostly highly experienced RN BSNs responsible for much of the hands-on research tasks performed at each research visit. They will typically interview the research subjects, administer questionnaires and some of the testing not done by research assistants or investigators.
Investigational Medicine or Treatment: This designates the medication being evaluated by the clinical research study. The medication is not FDA-approved for the indication being evaluated in the clinical research study. Another term commonly used for this is Investigational Product.
Investigational Review Board(IRB): A committee that reviews clinical research protocols, including the Informed Consent Form and all materials used directly for recruitment into a clinical research protocol. IRB approval must be obtained before any clinical research study can be initiated.
Placebo: A medication or treatment that does not contain any known active medication or therapy.
Protocol: The document provided by the Sponsor that details the objectives of the research study, and details in an almost cookbook fashion the specific methods and procedures to be used during the research visits. For all clinical research protocols in the US, the FDA reviews and approves the protocol. The FDA approval only applies to the protocol design, and does not mean that the FDA has approved the investigational medicine or treatment being tested by the protocol.
Principal Investigator (PI): The individual with primary responsibility for insuring research subject safety and well-being, and insuring the protocol is conducted properly. Proper conduct includes multiple aspects of the study, including but not limited to addressing questions from research staff, helping determine eligibility or ineligibility, evaluating adverse events, overseeing proper storage of the investigational medicine, among other responsibilities.The Principal Investigator is always a physician (MD or DO).
Sub-Investigator: A medical professional working with the Principal Investigator, assisting in conduct of the study.
Sponsor: The company or agency that funds and monitors the clinical research study. At SEC Clinical Research, the Sponsor is usually a pharmaceutical company that intends to use the clinical research results to support a licensing application to the FDA.