Research A to Z

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug.                                  

Studies in this phase are by some companies categorized as "Phase IIIB studies." While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as the FDA. Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life.

This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities. They will review the submission, and, it is hoped, give the sponsor approval to market the drug. Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market.

Phase V is a growing term used in the literature of translational research to refer to comparative effectiveness research and community-based research; it is used to signify the integration of a new clinical treatment into widespread public health practice.

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

• A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
• A chemically inert substance given in the guise of medicine for its psychologically suggestive effect; used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than actual power of a drug.

An adverse event that         

• is a lesser known or possible effect of the drug, device, or procedure
• occurred within a sequence of time from the drug’s administration, device implantation and/or activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure
• could be explained by the characteristics of the population under study

A specific adverse event that has not yet been reported to the IRBMED. For example, the hospitalization of a subject due to infection after the second dose of a study medication would be a "previously unreported adverse event" even if there had been an earlier report submitted to IRBMED when that same subject had been previously hospitalized due to similar infection after the first dose. All previously unreported adverse events are reported to IRBMED using the AE submission in eResearch.

The Primary Management Group in OnCore is the CTSU that the trial is supported by. 

The scientist or scholar responsible for the conduct of research or other activity, described in a proposal for an award. The PI is responsible for all programmatic and administrative aspects of a project or program. The scientist or scholar with primary responsibility for the scientific, technical and administrative conduct of a funded research project. See also: Investigator and Lead Researcher

Federal Regulations define "prisoner" as "any individual involuntarily confined or detained in a penal institution”. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

The subsection or subcommittee of the IRBMED charged with handling HIPAA matters referred to the IRBMED and in accordance with the Standard Operating Procedures (SOPs)

 When the Medical Director Documents Review Determination as Approved

An application for funding that contains all information necessary to describe project plans, staff capabilities, and funds requested. Formal proposals are officially approved and submitted by an organization in the name of a principal investigator.

Individually identifiable health information is considered PHI protected under HIPAA when ALL of the following apply: 

• Obtained from a covered entity (healthcare provider, plan, or clearinghouse)
• Containing any direct or indirect identifiers from a defined “HIPAA identifiers”  list
• About health, healthcare, and/or payment for healthcare 

See Research A-Z webpages HIPAA and Protected Health Information (PHI).

A written description of any change(s) to or formal clarification of a protocol. Submit protocol amendments to the IRBMED using the Amendment submission in eResearch. Except to avoid the possibility of immediate harm to subjects, protocols should not be changed without prior IRB authorization. When changes for safety are made, an amendment should be submitted to the IRBMED within 7 days of the action.

Individual who manages the study protocol (i.e. consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)

Term used by FDA and some sponsors to refer to a departure from the protocol that receives approval from the IRB before implementation (a one-time exception as distinguished from an amendment to the protocol). Approval requests for a protocol exception should be submitted using the ORIO submission in eResearch. Investigator should specify the extent of the exception (e.g., one-time only for patient X and note if data will be included in the study analysis).  If the exception is to become a permanent change, an Amendment submission in eResearch needs to be submitted.

Study Team members who will be engaged in the conduct of the trial as Protocol Staff

There are three different options for entering the Protocol Type into OnCore. When determining the Protocol Type, select from the drop-down list using the following definitions: 1. Treatment: Clinical trials with therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions. 2. Diagnostic: Clinical trials directly testing the efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease. 3. Other

The Protocol Related tab identifies all the events that relate to the operation of the protocol as a whole (IRB fees, IRB Amendment fees, Advertising fees, and Quarterly Pharmacy fees). These are fees that you would incur even without a single subject accrued.