Research A to Z

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PAN (Project Award Notice)

A Project Award Notice (PAN) is prepared and distributed by ORSP via eResearch to the Principal Investigator and all signers off on a PAF serves to establish the project/grant number (PGN) for the project.

Parallel Track IND

The FDA's Parallel Track policy permits wider access to new drugs for life-threatening diseases under a separate treatment protocol (Parallel Track IND) that "parallels" the controlled Phase II and III clinical trials performed to establish the safety and effectiveness of investigational new drugs. For example, under this prospective mechanism, persons with AIDS and HIV-related diseases who are not able to take standard therapy or for whom standard therapy is no longer effective, and who are not able to participate in ongoing controlled clinical trials, can have access to promising investigational new drugs. Applications to permit expanded availability of an investigational new drug under the Parallel Track mechanism must be submitted (typically by the manufacturer of the drug) to the FDA as an amendment to the existing IND.

Participation

When participation is anonymous, it is impossible to know whether or not an individual participated in a study. When participation is confidential, the study participation of a specific individual is recorded, but cannot be known by anyone except the researcher and authorized research staff that has legitimate access to participation records.

Pass Thru Procedures

These charges are billable to the sponsor. When a procedure marked Pass Thru occurs on a subject visit, the charge appears as its own invoiceable item in the Financials Console. When added to an invoice, each Pass Thru procedure is listed as its own line item. Pass Thru charges are not included in the total calculated cost for billable milestones.

PC (Professional Component)

Money to Physician for services provided (CPT)

Phase 0 Trial

Phase 0 is a designation for exploratory, first-in-human trials conducted in accordance with the FDA’s Guidance on Exploratory IND Studies. Phase 0 trials are also known as human micro-dosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single sub-therapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs). A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data.

Phase I Trial

Phase I trials are the first stage of testing in human subjects. Normally, a small group of 20-100 healthy volunteers will be recruited. This phase is designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in a clinical trial clinic, where the subject can be observed by full-time staff. These clinical trial clinics are often run by contract research organizations who conduct these studies on behalf of pharmaceutical companies or other research investigators. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials also normally include dose-ranging, also called dose escalation studies, so that the best and safest dose can be found and to discover the point at which a compound is too poisonous to administer. The tested range of doses will usually be a fraction of the dose that caused harm in animal testing. Phase I trials most often include healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have terminal cancer or HIV and lack other treatment options. Volunteers are paid a fee for their time spent in the volunteer center. Pay depends on length of participation. There are different kinds of Phase I trial: Single Ascending Dose; Multiple Ascending Dose; and Food effect.

Phase II Trial

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (100-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects. Phase II studies are sometimes divided into Phase IIA and Phase IIB.

Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).
Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

Some trials combine Phase I and Phase II, and test both efficacy and toxicity.

Phase III Trial

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 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.

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)

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).

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.