Glossary

This glossary offers definitions for terms used across PCORI.org—and in our funding process—as we apply PCORI’s unique approach to healthcare research.

A

Administrative Official (AO)

The individual within the recipient organization who is responsible for the proper administration of the contract, including, but not limited to, overseeing the submission of the contract activation, contract renewals, and additional materials required by PCORI’s policies and procedures.

Allowable Costs

A cost that is approved within the budget and is not otherwise unallowable under the PCORI Funded Research Policies. A direct cost is allocable to the project if the goods or services involved are chargeable or assignable to the project in accordance with relative benefits received or other equitable relationship. As a result, a cost is allocable to the funded project if (1) it is incurred solely to advance the work under the project, or (2) it benefits both the funded project and other work of the recipient organization, in proportions that can be approximated through use of reasonable methods.

Award Page Title

A less-technical, often abbreviated version of the researchers’ project title.

Awarded - Contract Pending

The project has been approved by PCORI’s Board of Governors, and it is receiving a PCORI business and programmatic review or the final research contract is being executed.

B

Biosketch

A profile of the experience and accomplishments of the key personnel in an application. A biosketch also satisfies the requirements of the PCORI professional profile.

Burden

The frequency of the condition, the expected mortality and morbidity, and/or the degree of suffering associated with symptoms, complications, or other consequences of the condition. Additionally, it may include the costs to the US population of healthcare services used, the individual patient’s out-of-pocket expenses, as well as intangible costs to the patient, such as time away from paid or unpaid occupations.

C

Clinical Practice Guidelines

Systematically developed statements or recommendations to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. They present indications for performing a test, procedure, or intervention, or the proper management for specific clinical problems. Guidelines may be developed by government agencies, institutions, organizations such as professional societies or governing boards, or by convening expert panels.

Closeout

The process by which PCORI determines that all applicable administrative actions and all required work of the contract have been completed and officially closes the contract.

Co-Investigator (Co-I)

An individual recognized by the prime institution and the principal investigator (PI) as someone making a significant contribution to a project. The Co-I is an individual who the PI relies on to assume responsibilities related to the execution of the project and to commit a specified percentage of time to the project. A Co-I is considered “key personnel” and may be employed by or formally affiliated (through written agreement) with the prime institution or a collaborating institution. The patient and/or stakeholder partner may be listed as a Co-I. The designation of a Co-I does not affect the PI’s roles and responsibilities nor does it imply a Dual PI Award.

Co-Principal Investigator (Co-PI)

An individual recognized by the prime institution and the principal investigator (PI) as someone who shares scientific and administrative leadership responsibilities for a project with the PI. The Co-PI is an individual who the PI relies on to contribute substantively to the scientific development and direction of the project in addition to the execution of the project. The Co-PI shares responsibility with the PI for ensuring that milestones are achieved and contracted deliverables are completed on time. The Co-PI is considered “key personnel” and may be employed by or formally affiliated (through a written agreement) with the prime institution or a collaborating institution. The patient and/or stakeholder partner may be listed as a Co-PI. The designation of a Co-PI does not affect the PI’s roles and responsibilities nor does it imply a Dual PI Award.

Comparative Effectiveness Research (CER)

The direct comparison of two or more existing healthcare interventions to determine which interventions work best for which patients and which interventions pose the greatest benefits and harms. The core question of CER is which treatment works best, for whom, and under what circumstances.

Conflict of Interest

As defined by PCORI’s authorizing legislation, a Conflict of Interest is any “association, including a financial or personal association, that has the potential to bias or has the appearance of biasing an individual’s decisions in matters related to the Institute or the conduct of activities” [Patient Protection and Affordable Care Act, Pub L No. 111-148, 124 Stat 727, §6301(a)(3)]. Conflicts of Interest will be considered and managed throughout every step of the review and selection process, including, but not limited to, the technical and programmatic reviews, the selection and assignment of scientific and stakeholder reviewers, Board of Governors deliberations, and post-award negotiations and monitoring.

Consultant

Typically an individual who is not involved with the management of the project, but instead provides general services or subject matter expertise for an hourly fee. Applicants must include a letter of support from the consultant detailing their work and rate of compensation per hour. The patient and/or stakeholder partner may be listed as a consultant.

Contact Principal Investigator (PI)

If electing to submit a Dual PI Award application with two PIs, the prime institution must designate one PI as the Contact Principal Investigator. The Contact PI is the PI responsible for submitting the application and all contracted deliverables to PCORI and will serve as PCORI's primary point of contact for all communication. The Contact PI must be employed by or formally affiliated (through written agreement) with the prime institution and is named in the award contract.

Contract

The legally binding document that PCORI uses to make awards for research projects.

D

Data Universal Numbering System (DUNS)

A unique identifier assigned to a single business entity. You may apply for a DUNS number online.

Decisional Dilemma

The specific clinical decision(s) and/or treatment choice(s) confronted by the decision-makers. The application should describe why this decision is important to patients, the uncertainty faced by patients, clinicians, and other decision makers in this area, and how the proposed research will inform those decisions.

Dissemination (active)

The intentional, active process of identifying target audiences and tailoring communication strategies to increase awareness and understanding of evidence, and to motivate its use in policy, practice, and individual choices. The purpose of dissemination is to spread and sustain knowledge and the associated evidence-based interventions.

Dissemination (passive)

Sometimes called research diffusion, is an untargeted dissemination process whereby new evidence is absorbed and acted upon by a small body of highly motivated recipients.

Dual Principal Investigator (PI) Award

An award in which the prime institution has designated two individuals as PIs who share equally the authority and responsibility for leading and directing the project, intellectually and logistically. The presence of two PIs on an application or award diminishes neither the responsibility nor the accountability of any individual PI.

E

Employer Identification Number (EIN)

The Federal Tax Identification Number used to identify a business entity. You may apply for an EIN in various ways, including online.

F

Financial Official (FO)

The individual designated by the recipient organization who is responsible for the proper accounting of contract funds and the submission of payment details. The FO is responsible for completing and certifying the required yearly expenditure reports.

Fringe Benefits

A form of pay for the performance of services. Fringe benefits commonly include health insurance, group term life coverage, and nonwage compensation.

I

Implementation

The deliberate, iterative process of integrating evidence into policy and practice through adapting evidence to different contexts and facilitating behavior change and decision making based on evidence across individuals, communities, and healthcare systems.

Indirect Costs

Costs not directly accountable to the project. Indirect costs include taxes, administration, personnel (not directly related to the project), and security costs.

Inpatient Costs

Costs incurred for patient study participants who are formally admitted to a hospital on doctor’s orders.

Institutional Review Board (IRB)

A group that follows federal regulations, state laws, and institutional policy to review, monitor, and approve research in order to protect the ethical rights and privacy of the subjects involved.

K

Key Personnel

Individuals who contribute to the scientific development or execution of the project in a substantive and measurable way. The contribution is independent of financial compensation.

L

Letter of Intent (LOI)

A notification to PCORI that an organization intends to apply. Submission of an LOI is a prerequisite to submitting an application.

Letters of Collaboration

Signed letters from each collaborating individual or organization that will demonstrate that the PI has the support or resources necessary for the proposed work. Letters of support from patient and stakeholder partners should clearly describe the origin of the study topic and the role of the patient partners in defining the question, outcomes, comparators, goals and outcomes, etc. Letters from the partners or partnering organizations affirming support to disseminate and implement research findings that are germane and warranted for implementation are also highly encouraged.

Letters of Organizational Support

Letters of support signed by the Department Chair or appropriate organizational official, confirming the institutional support of the proposed project, space to conduct the research, equipment, and other resources available for the project, including staff. A letter from the leadership of your department or organization affirming support to disseminate research findings that are appropriate and warranted for implementation may also be included.

M

Merit Review

A review of the scientific and technical merit of applications for funding. Merit review consists of both online and in-person reviews by qualified reviewers who read, score, and provide feedback on the applications.

Merit Review Officer (MRO)

A scientist who presides over a merit review panel and is responsible for coordinating and reporting the discussion of each application assigned to it. The MRO serves as an intermediary between the applicant and reviewers and prepares summary statements for all applications reviewed.

Methodology Committee

Per PCORI’s authorizing legislation, the 17-member group working to develop and advance scientific methods in patient-centered outcomes research. The Methodology Committee is a sub-tending committee that supports the PCORI Board of Governors.

O

Organization

The institution/organization in which the project originates, or the primary institution or organization that received funding for the project.

Other Principal Investigator

An additional lead investigator. This investigator may be affiliated with a different institution or organization from the Principal Investigator.

Outpatient Costs

Costs incurred for patient care when the patient is not formally admitted to a hospital.

P

Patient-Centered Outcomes Research (PCOR)

Research that helps people and their caregivers communicate and make informed healthcare decisions, while allowing their voices to be heard in assessing the value of healthcare options. This research answers patient-centered questions. A full definition can be found on our website.

Patients

Individuals who have or have had the condition under study; it may include patient surrogates or caregivers as well. It does not necessarily mean, but does not exclude, patient advocates or patient navigators.

PCORI Funding Announcement (PFA)

PCORI's notice of a funding opportunity and request for applications. A PFA describes our intent to fund research in specific areas. Each PFA has a summary of the opportunity and guidance for proposing research for funding. It is accompanied by Application Guidelines and templates or forms for submission through PCORI Online.

PCORI Funding Center

The central location on PCORI’s website where applicants can access all templates, guidelines, information, and training needed to prepare and submit an application. Available at in our funding center.

PCORI Online System

PCORI’s online application and award management system, designed to facilitate the applicant’s submission of materials, and the activation of a contract through completion and closeout. Available in the PCORI Online System.

Pilot Project

PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community.

Primary Condition/Disease

These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. But you can use the keyword search box to find any PCORI-funded study.

Principal Investigator

The lead researcher and primary contact for the project.

Professional Profile

A profile of the experience and accomplishments of a person who will play a significant role on a PCORI-funded research project. Also see Biosketch.

Program Director

The individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as Program Directors/Principal Investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the applicant organization, or as appropriate, to a collaborating organization for the proper conduct of the project or program including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI.

Programmatic Review

A review of the scientific portion(s) of the application to ensure that it meets PCORI’s programmatic requirements. These may include but are not limited to: presence of a CER question; absence of a cost effectiveness question; and, when applicable, addressing the specific research question in a targeted funding announcement.

Project End Date

Includes the research project period and may be subject to modification to allow other research-related activities such as peer review.

Project Start Date

The date of approval to fund by the PCORI Board of Governors. The actual project start dates vary as the negotiation of project milestones must be completed before the contract can be fully executed.

Project Status

View definitions of the life cycle of an awarded project

Project Title

The title of the project supplied by the project lead or team.

Project Type

Research projects are designed to improve patient outcomes by comparing two or more care approaches and enhance the methods and infrastructure needed to support such research. Research support projects are not research studies but designed to encourage better integration of patients and other stakeholders into the research process.

Public Abstract

A summary of the research plan that is written for, and will be accessible to, a general, lay audience.

R

Randomized Controlled Trial (RCT)

An experiment in which participants are randomly allocated to receive one of two (or more) diagnostic, preventive, therapeutic, or palliative interventions and are then followed to determine the effects of the intervention.

Reasonable Costs

A cost may be considered reasonable if the nature of the goods or services acquired or applied is appropriate and justifiable. The amount involved reflects the action that a prudent person would have taken under the circumstances prevailing at the time the decision to incur the cost was made.

Renewed Support

Approval of an additional funding period for the same project within the approved project period. The original agreement will remain in place and additional funds obligated near the end of each funding period. Any funds remaining on the contract prior to the new obligation will remain available for the recipient’s use.

Research Team

A group of people organized to function cooperatively to design and conduct research. For PCORI, teams should be interdisciplinary, and include patients and other stakeholders as key contributors to the research process.

Resubmission

An application that was submitted and received a summary statement, but was not funded and is being resubmitted to the same PFA for new consideration. An application that was withdrawn before merit review, or an LOI that was not invited to provide a full application, would not be considered a resubmission.

S

Stakeholders

Stakeholder partners may include members of constituencies based on professional, rather than personal, experience. For example, these constituencies can include: clinicians, purchasers, payers, industry, hospitals and health systems, policy makers, and training institutions. Some individuals may fit into several categories. Find more information on how PCORI defines stakeholders here.

State

The state where the project originates, or where the primary institution or organization is located.

Study Registration

PCORI-funded studies are required to register in ClinicalTrials.gov (NCT) or the National Library of Medicine’s Health Services Research Projects in Progress (HSRP) database. Study registration information includes study aims, patient population eligibility, interventions and comparators, outcomes measures, and, as required, participant recruitment status.

Subcontractor

An individual or group who takes a portion of a contract from the prime contractor (awardee) or from another subcontractor.

T

Technical Abstract

A summary of the research plan that is written for scientists and researchers.

Y

Year Awarded

The year the PCORI Board of Governors approved funding for the project or the year the proposal received a notice of award.