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Phase IV Trial

Phase IV trial is also known as Post-marketing surveillance Trial. Phase IV trials involve the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term AE over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

Phase V Trial

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.

PHI

Protected Health Information (including demographic information) about a patient that (i) is created or received by a health care provider or health plan; (ii) relates to the past, present, or future physical or mental health of the patient; and (iii) identifies the patient or with respect to which there is a reasonable basis to believe it could be used to identify the patient

 

PHS

 Public Health Service

Placebo

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.

Placebo Effect

A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.

Placebo-Controlled Study

  • 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.

Planned Emergency Research

Research involving human subjects who are in need of emergency medical intervention (e.g., comparison of methods for providing cardiopulmonary resuscitation), but who cannot give informed consent because of their life-threatening medical conditions and who do not have an available legally authorized representative to provide consent.

Possibly related adverse event

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

Pre-Review

The process performed by a IRBMED Regulatory Team to determine that a submission for IRB review is complete, including the required materials, and that institutional requirements, such as completion of human subjects protection education and conflict of interest disclosure, have been met.

Previously Unreported Adverse Event

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.

Primary Completion Date

The date that the final subject is anticipated to be examined or receive an intervention at U-M for the purposes of final collection of data for the primary outcome.

Primary Management Group

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

Prime Sponsor

The original source of project funds named in the agreement, if not the Direct Sponsor. Some projects have Prime Sponsors

Principal Investigator (PI)

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

Principal Sponsor

The sponsor that enrollment should be attributed to for reporting purposes

Prisoner

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.

Privacy

Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. The state of being free from the observation, intrusion, or attention of others.

Privacy Board

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)

Private information

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. See the UMHS HIPAA Web site for further information. (hyperlink)

PRMC (Protocol review and monitoring committee) Approval

 When the Medical Director Documents Review Determination as Approved

Probably related adverse event

An adverse event that         

  • is lesser known or suspected effect of the drug, device, or procedure (listed in the protocol documents including IB, consent, publications, etc.)
  • follows a reasonable sequence of time from the drug’s administration, device implantation, activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure
  • ceases or diminishes with discontinuation of the drug, removal/discontinued activation of the device, or procedure

Proposal

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.

Prospective Studies

Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. These studies need not involve manipulation or intervention, but may be purely observational or involve only the collection of data.

Protected Health Information (PHI)

(Including demographic information) about a patient that (i) is created or received by a health care provider or health plan; (ii) relates to the past, present, or future physical or mental health of the patient; and (iii) identifies the patient or with respect to which there is a reasonable basis to believe it could be used to identify the patient

Protocol

The formal design or plan of an experiment or research activity; specifically, the plan submitted to a Scientific or Peer Review committee for review and to an agency for research support. The protocol usually also gives the background and rationale for the trial. The protocol includes a description of the research design, methodology to be employed, the eligibility requirements for prospective participants and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a project, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

Protocol Amendment

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.

Protocol Calendar

The details of the Protocol Calendar as defined in eCRFS/Calendars > Specifications: scheduled visits, procedures to be performed during each visit, and forms (eCRFs) used to record visit data.

Protocol Coordinator

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

Protocol Deviation

Accidental or unintentional changes to, or non-compliance with the research protocol that does not increase risk or decrease benefit or; does not have a significant effect on the subject's rights, safety or welfare; and/or on the integrity of the data. Deviations may result from the action of the subject, researcher, or research staff. Departure from the IRB approved research protocol without prior IRB approval for the variation.

Protocol Exception

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.

Protocol No.

This number should be updated with a study HUM# when assigned. Upon receiving the trial’s HUM number, DO NOT include the HUM prefix in this field. All leading zeros should be included. If not assigned during the feasibility process, enter it into the PC Console.

Protocol Staff

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

Protocol Target Accrual

Overall accrual goal for the protocol, including all affiliated institutions if a multisite trial.

Protocol Type

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

Protocol Violation

Accidental or unintentional changes to or non-compliance with the IRB approved protocol without prior sponsor and IRB approval. Violations generally increase risk or decrease benefit, affects the subject's rights, safety, or welfare, and/or the integrity of the data.

Protocol-related Costs

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.

QA/QI

Quality Assurance/Quality Improvement

Radioactive Drug

Any substance defined as a drug the Federal Food, Drug and Cosmetic Act that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. Included are any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug and "radioactive biological products," as defined in 21 CFR 600.3(ee). Drugs such as carbon-containing compounds or potassium-containing salts containing trace quantities of naturally occurring radionuclides are not considered radioactive drugs.

Radioactive Drug Research Committee (RDRC)

An institutional committee responsible for the use of radioactive drugs in human subjects for research purposes. Research involving human subjects that proposes to use radioactive drugs must meet various FDA requirements, including limitations on the pharmacological dose and the radiation dose. Furthermore, the exposure to radiation must be justified by the quality of the study and the importance of the information it seeks to obtain. The committee is also responsible for continuing review of the drug use to ensure that the research continues to comply with FDA requirements, including reporting obligations. The committee must include experts in nuclear medicine and the use of radioactive drugs, as well as other medical and scientific members [21 CFR 36.1].

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