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P

P01: See Program Project Grant.

P30: See Cancer Center Support Grant.

PA: See Program Announcement.

PAR: See Program Announcement Reviewed in an Institute.

Parent Announcement: NIH-wide funding opportunity announcement enabling applicants to submit an electronic investigator-initiated grant application for a single grant mechanism, e.g., Research Project Grant (Parent R01).

Parent Committee: The review committee responsible for scientific peer review and final merit scoring of multicomponent (e.g., Centers, Cooperative Groups) applications. To make its assessment, the parent committee draws on written reports from work groups, the response of the applicant to the draft review report, and deliberations of panel members.

PAS: See Program Announcement with Set-Aside Funds.

Patient Oriented Research: Research into disease mechanisms, therapeutic interventions, clinical trials, or the development of new technologies. Also see clinical research.

Payline: A percentile-based and numerical funding cutoff point determined at the beginning of the fiscal year. Institutes determine paylines by balancing projected grant numbers, grant budgets, and monies in the budget.

Peer Review: The process by which applications for NIH support are evaluated by groups of scientists from the extramural research community. The objective of peer review is to evaluate and rate the scientific and technical merit of the proposed research or research training. [See also Dual Review Process.]

Peer Reviewer: Scientist who reviews grant applications or contract proposals for NIH. This includes the scientific review group chair, who leads the discussions.

Percentile Rank: In the context of scoring applications for funding, the relative position of each priority score among the scores assigned by a scientific review group at its last three meetings. The lower the numeric value of the percentile score the better. The range is from .5 to 99.5.

Person Months: Measurement of a person's effort in academic, summer, or calendar months a year. Used on NIH applications and other forms instead of percent effort.

Phase 0 Clinical Trial: A Phase 0 (zero) clinical trial is designed to study the pharmacodynamic and pharmacokinetic properties of a drug. In a Phase 0 trial, a limited number of doses, and much lower doses of the drug are administered, therefore there is less risk to the participant.

Phase I Clinical Trial: Phase I clinical trials are done to test a new biomedical or behavioral intervention in a small group of people (20 to 80) for the first time to determine the metabolism and pharmacologic actions of the drug in humans, safety, side effects associated with increasing doses, and if possible, early evidence of effectiveness. Phase I trials are closely monitored and may be conducted in patients or healthy volunteers.

Phase II Clinical Trial: Phase II clinical trials are done to study the biomedical or behavioral intervention in a large group of people (several hundred) to determine efficacy and to further evaluate safety. They include controlled clinical studies of effectiveness of a drug for a particular indication or indications in patients with the disease or condition under study and determination of common, short-term side effects and risks associated with the drug. Phase II studies are typically well controlled and closely monitored.

Phase III Clinical Trial: Phase III studies are expanded controlled and uncontrolled studies performed after preliminary evidence of drug effectiveness has been obtained. They are intended to gather additional information about effectiveness and safety needed to evaluate the overall benefit-risk relationship of the drug and to provide adequate basis for physician labeling. These studies usually include anywhere from several hundred to several thousand subjects.

Phase IV Clinical Trial: Phase IV studies are postmarketing studies (generally randomized and controlled) carried out after licensure of a drug. These studies are designed to monitor effectiveness of an approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

PHS: See Public Health Service.

PHS Policy on Humane Care and Use of Laboratory Animals: Compliance with PHS policy is a term and condition of all PHS awards involving live vertebrate animals.

Placebo-Controlled Study: A method of investigation of drugs in which an inactive substance (placebo) is given to one group of patients, while the drug being tested is given to another group.

PO: See Project Officer.

Pre-application: A statement in summary form of the intent of the applicant to request funds. It is used to determine the applicant's eligibility and how well the project can compete with other applications and eliminate proposals for which there is little or no chance for funding.

Principal Investigator: The one person designated by, and responsible to, the applicant/awardee institution for the scientific and administrative direction and proper conduct of all aspects of the project or activity supported by the grant. He or she is responsible for the scientific and technical direction and day-to-day management of the project or program, and is accountable to the grantee for the proper conduct of the project or activity.

Priority Score: A numeric rating that reflects the scientific and technical merit of proposed research relative to the “state of the science.” The score is a quantitative indicator that ranges from 100 to 500. Individual IRG members assign scores from 1.0 (highest merit) to 5.0 (lowest merit). Votes are cast in 0.1 increments. The priority scores are the average of member votes multiplied by 100.

Privacy Act: A law that protects against needless collection or release of personal data. Records maintained by NIH with respect to grant applications, grant awards, and the administration of grants are subject to the provisions of the Privacy Act.

Procurement: The acquisition of property or services for the direct benefit or use of the Government, generally via a contract.

Program Announcement (PA): An announcement by an NIH Institute or Center requesting applications in stated scientific areas. Generally, money is not set aside to pay for them. [See Program Announcement with Set-Aside Funds, below.]

Program Announcement Reviewed in an Institute (PAR): Program Announcement with special receipt, referral and/or review considerations.

Program Announcement with Set-Aside Funds (PAS): A PAS is a PA that includes specific set-aside funds, as described in the announcement.

Program Director/Officer: The NCI scientist administrator responsible for development of initiatives and scientific management of NCI-sponsored research programs. He/she is the focal point for all science-related activities associated with the negotiation, award, and administration of grants.

Program Income: Gross income earned by a grantee directly generated by the grant-supported project or activity or earned as a result of the award.

Program Project Grant (P01): An assistance award for the support of a broadly based multidisciplinary research program that has a well-defined central research focus or objective. It may also include support for common resources (cores) required for conduct of the P01 research projects. Interrelationships between projects are expected to result in a greater contribution to program goals than if each project were pursued separately.

Programmatic Reduction: The dollar amount a grant award is reduced from the amount recommended by the Scientific Review Group. This is done so that Institutes can maintain a sufficient number of grants in their portfolio and to combat inflation of grant costs.

Project: A research component of a larger multicomponent application (e.g., P01), with a separate detailed budget.

Project Leader: The person responsible for the scientific direction and conduct of an individual P01 research project.

Project Officer (PO): The PO serves in an administrative and advisory capacity throughout the contracting process. The PO recommends potential Technical Evaluation Panel members to the SRA. Although serving in an advisory capacity with no voting rights, the PO may fully participate in the oral discussion of proposals, providing supportable comments that voting panel members may consider in their evaluations.

Project Period: The total time for which support of a project has been recommended (usually no more than 5 years), consisting of one or more budget periods. Competing extensions of a project period are subject to peer review, reevaluation of the activity, and recompetition for available funds.

Proposal: A document submitted by an offeror in response to an RFP.

Protocol: The detailed plan for conducting a clinical trial. It states the trial’s rationale, purpose, drug or vaccine dosages, length of study, routes of administration, who may participate, and other aspects of trial design. Public Access Policy: The NIH policy designed to ensure that the public has access to the published results of NIH-funded research. See http://publicaccess.nih.gov/

Public Health Service (PHS): A component of the U.S. DHHS. NIH is the largest agency within the PHS.

PubMed: PubMed provides access to citations from biomedical literature. These citations are indexed with a PMID, a series of numbers.

PubMed Central: PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed journal papers. These papers are indexed with a PMCID, a series of numbers preceded by ‘PMC’. PMC content is publicly accessible and integrated with other databases. See: http://www.pubmedcentral.nih.gov/.

PubMed Central Reference Number (PMCID): The reference number assigned to an article or manuscript archived in PubMed Central. The PMCID is the number that must be cited on applications, proposals or reports as part of compliance with the Public Access Policy. See also “Citation ID.”

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