Clinical Research Dictionary

Clinical Research Dictionary

(Glossary of Terms and Acronyms)

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P
P Value		The lowest level of significance at which a given null hypothesis can be rejected; that is, the probability of observing a result as extreme or more extreme than that observed if the null hypothesis is true. See statistical significance.
Package Insert	PI	1.) A leaflet, provided either in or on the product packaging. It is printed in the local language and contains information about the product for the consumer, including guidance for safe usage. The wording in this insert must be approved by regulatory authorities. 2.) A drug or biologic product information sheet which summarizes the information obtained during the entire development process. See Prescription Drug Labeling
Pairing		A method by which subjects are selected so that two subjects with similar characteristics are assigned to a set, where one receives one treatment and the other receives a different treatment.
Pan-American Health Organization	PAHO	The Pan American Health Organization (PAHO) is an international public health agency with 100 years of experience in working to improve health and living standards of the countries of the Americas. It serves as the specialized organization for health of the Inter-American System. It also serves as the Regional Office for the Americas of the World Health Organization and enjoys international recognition as part of the United Nations system.	http://www.paho.org/
Pap Test		A test to check for cancer of the cervix, the opening to a woman's womb. It is done by removing cells from the cervix. The cells are then prepared so they can be seen under a microscope.
Paper Trail		Activities associated with each stage of a clinical trial that are recorded on paper in a variety of document types (e.g., forms, letters, reports).
Parallel Design Trial		See Parallel Trial
Parallel Group Trial		See Parallel Trial
Parallel proposals		When a proposal is submitted to more than one sponsor, with the understanding that funding would be accepted from only one.
Parallel Study Design		See Parallel Trial
Parallel Trial		Volunteers are randomized to one of two differing treatment groups and usually received the assigned treatment during the entire trial.
Parallel Track		1.) A drug accessibility plan allowing AIDS therapies to be made available upon completion of Phase I trials to subjects unable to enroll in controlled trials. 2.) A system of making experimental drugs available to individuals who are ineligible for or unable to participate in clinical trials.
Parameter		1.) A variable which partly or wholly characterizes a probability distribution. In clinical trials, parameters include factual information (age, date of recovery), measurements (blood pressure, white cell count), clinical assessments (disease ratings) and subject self-evaluation (pain assessment). 2.) A constant in a model, or a constant that wholly or partially characterizes a function of probability distribution. (mathematics and statistics)
Parent		A child's biological or adoptive parent.	21 CFR 50.3 45 CFR 46.402 (d)
Parent account		The main project account to which sub-accounts are subsidiary.
Parental Permission		See Permission
Patent Application		Document submitted to the U.S. Patent & Trademark Office (or Foreign Patent Office) requesting that a patent be issued. Issuance usually takes two years or longer.
Participant		See Subject
Partnership for Human Subject Protection	PHRP	New accreditation program instituted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Committee for Quality Assurance (NCQA) that will seek to protect the safety and rights of participants in clinical trials and research programs in public and private hospitals, academic medical centers, and other research facilities in the United States and abroad.	http://www.phrp.org/
Paternalism		Making decisions for others against or apart from their wishes with the intent of doing them good.
Patient		1.) "Patient" is often used only to refer to persons with the disease or condition being studied, and "subject" is often used only to refer to healthy volunteers. However, the terms "patient" and "subject" are often used interchangeably. 2.) Person under a physician’s care for a particular disease or condition. See also subject/trial subject, healthy volunteer. See Subject
Patient Compliance		The degree of adherence by the patient to the study protocol (dosage schedule, evaluations performed, etc.).
Patient File		A file containing demographic and medical information about a patient or a subject. Such files are necessary to verify the authenticity of the information presented in the CRF. It may be paper or mixed paper and computer-based.
Patient Indentification Code		See Subject Identification Code
Patient Information		1.) All written and oral information concerning the clinical trial provided to subjects by the investigator in order to enable the subjects to decide on their participation in the trial (i.e., to give informed consent). 2.) Also, information collected by the patient and/or study coordinator during a trial, such as diary cards, journals, etc., relating to the trial, study drug, and/or symptoms.
Patient Informaton Display		See Subject Informaton Display
Patient Instruction / Assignment Sheet		Detailed instructions to patients for taking medication, recording symptoms, etc., generally developed by the sponsor or investigator.
Patient Log		A written list of all patients who were considered to be candidates for a study, regardless of the inclusion / exclusion criteria. This log is used to demonstrate a lack of bias in the selection process and to demonstrate efforts to find patients. Also referred to as Master Patient / Subject Log.
Patient Number		Unique alpha and/or numeric identifier assigned to each subject taking part in a clinical trial.
Patient Package Insert	PPI	See Package Insert
Patient Recruitment		See Recruitment (in relation to subjects)
Patient Tracking Sheet / Form		Study-specific scheduling log used to corroborate data recorded on case report forms by reflecting the patient's progression through the facility (e.g., dates of dosing start and stop, completion, termination, etc.). May be used by both the CRA and study coordinator.
Peer review		Review of a research proposal or paper by scientists who have expertise in the field.
Percentile		A number that corresponds to one of the equal divisions of the range of a variable in a given sample and that characterizes a value of the variable as not exceeded by a specified percentage of all the values in the sample. For example, a score higher that 97 percent of those attained is said to be in the 97th percentile.
Period Effect		Designated period during the course of a trial in which subjects are observed and no treatment is administered.
Periodic Reports		(US) Periodic drug experience reports must be filed at quarterly intervals for the first three years following the approval of a new drug, and annually thereafter.
Periodic Safety Update Report	PSUR	The PSUR is required as part of the FDA Post Marketing Drug Risk Assessment (PMDRA) program. The PSUR report is evolving with the recent ICH initiatives and the February 2004 FDA Guidance for industry information can be found at: http://www.fda.gov/cber/gdlns/ichclinsafety.htm. The PSUR software is designed to track the submission of Periodic Safety Update Reports by marketed product and country. The PSUR is a practical mechanism for summarizing interval safety data covering short periods of time and for conducting and overall safety evaluation. It is a tool for marketing authorization holders (MAHs) to conduct systematic analyses of safety data on a regular basis.	http://www.preludeinc.com/psur.htm
Peritoneal Dialysis	PD	A procedure that introduces dialysate into the abdominal cavity to remove waste products through the peritoneum (a membrane which surrounds the intestines and other organs in the abdominal cavity). It functions in a manner similar to that of the artificial semi permeable membrane in the hemodialysis machine. Three forms of peritoneal dialysis are continuous ambulatory peritoneal dialysis, continuous cycling peritoneal dialysis, and intermittent peritoneal dialysis.
Permission		The agreement of parent(s) or guardian to the participation of their child or ward in a clinical investigation.	21 CFR 50.3 45 CFR 46.402 (c)
Personal Digital Assistant	PDA	A lightweight, hand-held, usually pen-based computer used as a personal organizer. (i.e., Palm Pilot)
Pharmaceutical Alternatives		Drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in the same amount or dosage form or as the same salt or ester. Each such drug product individually meets either the identical or its own respective compendia or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times and/or dissolution rates.	21 CFR 320.1
Pharmaceutical Education & Research Institute	PERI	PERI is a not-for-profit organization that has been serving the pharmaceutical industry since 1989. Our entire operations revolve around providing you with the highest quality training available to assist you in your current position, and provide you with educational opportunities to enhance your long-term learning. No matter what area of the healthcare products industry you work in, PERI has training programs that will provide significant value to both you and your company. The PERI staff, Board of Directors, Advisory Committees, and our expert industry Faculty strongly believe that we are training today's professionals to develop tomorrow's cures.	http://www.peri.org/
Pharmaceutical Equivalents		Drug products that contain identical amounts of the identical active drug ingredient, i.e., the same sat or ester of the same therapeutic moiety, in identical dosage forms, but not necessarily containing the same inactive ingredients, and that meet the identical compendia or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times and/or dissolution rates.	21 CFR 320.1
Pharmaceutical Research and Manufacturers of America	PhRMA	United States based association that represents the country’s leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives.	http://www.phrma.org/
Pharmacist		A person qualified to prepare and dispense drugs and required by some institutions and governments to do the same for investigational drug.
Pharmacodynamics	PD	1.) Action of a drug on the body. 2.) The branch of pharmacology that studies reactions between drugs and living structures, including the processes of bodily responses to pharmacological, biochemical, physiological, and therapeutic effects.
Pharmacoeconomics		The branch of economics that applies cost-benefit, cost-effectiveness, cost-minimization, and cost-utility analyses to compare the economics of different pharmaceutical products or to compare drug therapy to other treatments. The discipline compares various treatment options in terms of their cost, both financial and as they related to quality of life. Sometimes referred to as outcomes research.
Pharmacogenetics		The study of the way drugs interact with genetic makeup or the genetic response to a drug.
Pharmacogenomics		Identification and use of Genomic biomarkers for drug efficacy, toxicity and method of action.
Pharmacokinetics	PK	The study of the bodily absorption, distribution, metabolism, and excretion of drugs.
Pharmacological Studies		These types of studies are generally conducted first because the insights gained, particularly regarding adverse effects, can influence the direction of later toxicological testing. The studies determine dose-response relationships, the drug's duration and mechanism of action, and explore the drug's effects on the major physiological systems.
Pharmacology		The study of the characteristics, effects, and uses of drugs and their interactions with living organisms
Pharmacopeia		A standard reference book that gives information on the identification and characteristics of marketed drugs.
Pharmacovigilance		Term used for adverse event monitoring and reporting in some countries.
Pharmacy		Place where drugs are prepared and dispensed.
Phase I Studies		The introduction of a new drug or biologic into a small group of humans at a stage when only animal and in vito data are available. Primary emphasis is on safety and subjects are free of abnormalities or conditions that would complicate clinical interpretation. The objective of a Phase I trial is to determine human toxicity, absorption, distribution, metabolism, elimination (ACME), and other pharmacologic action. For certain diseases, Phase I studies are conducted in severly ill patients (e.g., cancer, AIDS).	21 CFR 312.21
Phase I Unit		A facility designed specifically for conducting studies involving normal, healthy volunteers. It may be operated by a sponsor company, a contract research organization (CRO), or a special unit of a hospital.
Phase IIa Studies		Pilot clinical trials to evaluate efficacy and safety in selected populations of about 100 to 300 subjects who have the disease or condition to be treated, diagnosed, or prevented. Often involve hospitalized subjects who can be closely monitored. Objectives may focus on dose-response, type of patient, frequency of dosing, or any of a number of other issues involved in safety and efficacy.	21 CFR 312.21
Phase IIb Studies		Generally well-controlled trials to evaluate safety and effecacy in patients who have the disease or condition treated, diagnosed, or prevented. These trials usually represent the most rigorous demonstration of a medicine's efficacy.	21 CFR 312.21
Phase III Studies		1.) The last and most expensive pre-marketing drug testing stage is the comparative evaluation of the new drug versus the standard therapy. These are large multi-center studies in populations of perhaps 1,000-3,000 patients for whom the medication is eventually intended. During these full-scale evaluations, the new drug is tested under conditions most closely resembling those under the druge would be used if approved for marketing. Phase III trials often provide much of the information needed for the package insert and labeling of the medication. 2.) Expanded controlled and uncontrolled trials that are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. See also Pivotal Trials	21 CFR 312.21
Phase IIIb Studies		1.) A study conducted prior to the drug approval, but after the well-controlled trials designed to lead to marketing approval has been completed. These studies usually focus on marketing or quality of life issues, or they may supplement or complete earlier trials. They may be conducted while the application for marketing approval is being prepared or reviewed. 2.) Trials run late in Phase 3 that often compare the investigational product with marketed product (i.e., market leaders), but cannot be used for marketing purposes until the marketing application is approved.
Phase IV Studies		1.) Studies conducted after the drug has been approved for marketing. The purpose of these studies include comparing the product to a competitor, exploring use in additional subject populations, or exploring adverse events. They may be used to evaluation formulations, dosages, durations of treatment, drug interactions and other factors. 2.) Certain post marketing studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. Phase IV studies that are primarily observational or non-experimental and are frequently called "Post-Marketing Surveillance".	21 CFR 312.85
Phase V Studies		Postmarketing surveillance is sometimes referred to as Phase V.
Phases of Clinical Trials		Clinical trials are generally categorized into four (sometimes five) phases. An investigational medicine or product may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.
Phenotype		The physical manifestation of a gene function.
Physician		A person who has received the degree of doctor of medicine (M.D.) or doctor of osteopathy (D.O.) following completion of a prescribed course of study in medicine and surgery in an accredited medical school or study in osteopathy in an accredited osteopathic school, respectively, and who, following a period of internship or residency, is licensed to practice medicine and surgery in a particular state or states.
Physician Assistant	PA	A specially trained and licensed or otherwise credentialed individual who performs tasks, which might otherwise be performed by a physician, under the direction of a supervising physician.
Physician Group		A partnership, association, corporation, individual practice association (IPA), or other group that distributes income from the practice among members. An IPA is considered to be a physician group only if it is composed of individual physicians and has no subcontracts with other physician groups.
Physician’s Desk Reference	PDR	1.) (US) Reference book, in which pharmaceutical companies list information about prescription drugs; a voluntary listing, not all drugs are included; there is also a book covering over-the-counter (OTC) drugs, call the PDR for Non-Prescription Drugs. 2.) Medical reference with the most up to date information about prescription drugs, including description, indications, how supplied, suggested dosage, contraindications, and adverse reactions.
Physicians’ Data Query	PDQ	PDQ is NCI's comprehensive cancer database. It contains peer-reviewed summaries on cancer treatment, screening, prevention, genetics, and supportive care, and complementary and alternative medicine; a registry of approximately 2,000 open and 13,000 closed cancer clinical trials from around the world; and directories of physicians, professionals who provide genetics services, and organizations that provide cancer care.	http://www.nci.nih.gov/cancertopics/pdq /cancerdatabase
Physician Extender		See Physician Assistant
Pilot Grant (Seed Grant)		A small project, generally funded through internal sources to help develop a project to the point where external funding can be obtained.
Pilot Study		A study may be conducted in a small number of patients to determine the feasibility of undertaking a larger-scale clinical developement of a product.
Pivotal Study		See Pivotal Trial
Pivotal Trial		1.) Generally the benchmark Phase IIb or III studies on which regulatory authorities base a decision about approving an investigational drug. In general, pivotal studies should be well-controlled, randomized, of adequate size, and whenever possible, double-blind. 2.) Outdated term for adequate and well-controlled Phase III trials, which provide the substantial evidence of effectiveness and safety upon which the investigational product is approved.
Placebo		An inactive substance or procedure designed to resemble the potential treatment being studied. Placebos can mimic pills, procedures (like acupuncture), or even surgery. Participants taking a placebo form the control group in blinded clinical trials.
Placebo Concurrent Control (in terms of Subject)		See Placebo Control (in terms of Subject)
Placebo Control (in terms of Subject)		Subjects who are randomly assigned to a placebo.
Placebo-Controlled Study		See Placebo-Controlled Trial
Placebo-Controlled Trial		Studies where the investigational drug is compared with an inert substance, usually in a double-blind study.
Placebo Effect		The changes that occur after a person takes a placebo. People often feel effects from placebos, in part because of their expectations about how a drug or device will work.
Plagiarism (in terms of Misconduct)		The appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
Planned Interim Analysis		A statistical analysis of study data outlined or described in the clinical protocol. See also Interim Analysis
Plausibility Checks		Computerized checks that are undertaken on the data entered into the database to ensure that the data are logical and consistent.
Policies and Procedures		See Standard Operating Procedures
Policy		A written principle or rule to guide decision-making
Portable Document Format	PDF	The native file format for Adobe Systems’ Acrobat. PDF is the file format for representing documents in a manner that is independent of the original application software, hardware, and operating system used to create those documents. A PDF file can describe documents containing any combination of text, graphics, and images in a device-independent and resolution independent format. These documents can be one page or thousands of pages, very simple or extremely complex with a rich use of fonts, graphics, color, and images.
Positive Trial		A trial in which the investigational drug is shown to have a therapeutic advantage over the standard of placebo therapy or is shown to be comparable to standard therapy in effectiveness with perhaps fewer side effects or other benefits.
Post Amendments Devices		Medical devices marketed after enactment of the 1976 Medical Device Amendments in the United States.
Post Marketing Surveillance		1.) Requirement that firms report adverse experiences of which they are aware of (for marketed products) to FDA. 2.) Ongoing safety monitoring of marketed drugs. A specific type of Phase IV (or V) study, post-marketing surveillance of a newly approved product is required by some regulatory agencies when all safety and efficacy questions have not been sufficiently resolved, or when new concerns arise after the use of the approved medication, or as an extended safety assessment. Often these long-term, large scale studies are necessary to resolve questions about rare adverse effects. See also Phase IV Studies or Phase V Studies
Power		The probability that a test statistic rejects the null hypothesis when the null hypothesis is false. Power is a function of the statistical significance level, the difference between parameters, the sample size, and the variability associated with the parameters of interest.
Power of Attorney		A medical power of attorney is a document that lets you appoint someone you trust to make decisions about your medical care. This type of advance directive also may be called a health care proxy, appointment of health care agent or a durable power of attorney for health care.
Practice (in relation to SOP)		An activity that is actually routinely performed, regardless of whether it is required in policy or specified in procedure.
Pragmatic Trial		Term used to describe a clinical study designed to examine the benefits of a product under real world conditions.
Pre Amendments Devices		Medical devices marketed before enactment of the 1976 Medical Device Amendments in the United States.
Pre-Clinical Testing		Studies designed to provide necessary evidence to support the safety of a drug by testing it on animals before it is testing on humans. Also called "Pre-Clinical Investigations" and "Pre-Clinical Study". See also Nonclinical Study
Predicate Devices		Currently legally marketed devices to which new devices may be found substantially equivalent under the 510(k) process in the United States.
Pre Existing Condition		Illnesses or disability for which the subject was treated or advised within a stipulated time period before enrolling on a trial.
Preferred Provider Organization	PPO	A health care organization composed of physicians, hospitals, or other providers, which provides health care services at a reduced fee.
Pregnancy		Encompasses the period of time from implantation until delivery	45 CFR 46.202(f)
Pre-Market Approval Application (in relation to investigational devices)	PMAA	1.) (US) The document submitted to the FDA to obtain marketing approval for medical device products. 2.)Any premarket approval application for a Class III medical device, including all information submitted with or incorporated by reference therein.	21 CFR 814.3
Pre Market Notification [510(k)]	PMN	The type of submission to FDA in which the applicant must establish that their device is substantially equivalent to a legally marketed device for most Class II devices and some Class I devices.
Pre-Proposal (White Paper)		A preliminary project description submitted to a sponsor; the sponsor selects some pre-proposals for submission of full proposals.
Prescribing Information		Information included in the prescription drug label to aid physicians in prescribing information. See Prescription Drug Labeling
Prescription	R_x	A doctor’s written authorization to purchase a medication
Prescription Drug		1.) (US) A drug, the use of which is controlled by the FDA and which is dispensed by a licensed pharmacist or medical practioner on the written order (prescription) of a license medical practioner. 2.) (UK) A drug available only against a prescription signed by a medical practioner. 3.) (Germany) A drug dispensed by a licensed pharmacist on written order (prescription) of an approved physical or dentist.
Prescription Drug Labeling		According to federal regulations, prescription drug labeling must be "informative and accurate... contain a summary of the essential scientific information needed for the safe and effective use of the drug..." and "be based, whenever possible, on the data derived from human experience." To enforce this, the FDA has authority over the format and types of information that appear on the drug container, and on the outer carton in which the drug is shipped to physicians, hospitals, pharmacies, and other prescription drug dispensers. See Labeling
Prescription Drug Marketing Act of 1988		(US) Legislation designed to prevent illigal diversion and sale of prescription drugs from legitimate distributors. Specifically, the law prohibits practices that might result in the sale of drugs that are adulterated, misbranded, counterfeit, expired, or subpotent.
Prescription Drug User Fee Act	PDUFA	1992 law passed by the United States Congress that authorized FDA to collect fees from companies that produce certain human drug and biological products.	http://www.fda.gov/cber/pdufa.htm
President's Commission		See President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research		An interdisciplinary advisory group, established by United States congressional legislation in 1978, which was in existence until 1983, and which issued reports on ethical problems in health care and in research involving human subjects.
President's Council on Bioethics		Committee that Advises the President of the United States on ethical issues related to advances in biomedical science and technology.	http://www.bioethics.gov/
Pre-Study Site Visit Report Form		A form that documents all the clinical monitor's objective findings concerning who attended the pre-study meeting, where the meeting took place, what transpired during the visit, the results of the meeting, the clinical monitor's recommendation and the reasons for these recommendationss, where the study will be conducted, and when it will start. This report also usually includes an assessment of the on-site facilities. Also called "Qualitification Visit Report Form".
Pre-Study Visit		A meeting conducted at a potential study site to introduce a prospective investigator to the study protocol, familiarize him/her with regulatory and sponsor obligations, and assess the investigator's interest and ability to carry out the project. Also referred to as "Qualitification Visit".
Pre-Trial Monitoring Report		Document such that the site is suitable for the trial	ICH E6 8.2.19
Pre-Trial Monitoring Visit		A visit that is made to a potential study center to determine whether the center has the experience, equipment and resources to undertake a proposed clinical trial.
Prevalence		The number of existing cases of a disease or condition in a given population at a specific time.
Prevention Trial		Clinical trials that address new methods of preventing disease
Preventive Services		Health care to keep you healthy or to prevent illness (for example, Pap tests, pelvic exams, flu shots, and screening mammograms).
Previously-Approved New Drugs		Existing drugs proposed for a new indication or existing drugs proposed for a new use pattern.
Previously Unreported Adverse Event (in relation to IRBMED)		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 section 6 of the Previously Approved Project Application.
Primary Care Physician	PCP	A doctor who is trained to give you basic care. Your primary care doctor is the doctor you see first for most health problems. He or she makes sure that you get the care that you need to keep you healthy. He or she also may talk with other doctors and health care providers about your care and refer you to them. In many managed care plans, you must see your primary care doctor before you see any other health care provider.
Primary Endpoints		Primary endpoints include death, serious morbidity, and other events whose presence or absence have a clear and definite clinical effect on a subject.
Prime contractor		The institution receiving the award from the sponsor.
Principal Investigator	PI	A clinician, usually a physician, with proven qualitifications who is responsible for the conduct of a clinical trial. See also Investigator
Principal Investigator (in terms of NIH)	PI	An individual designated by the grantee to direct the project or activity being supported by the grant
Priority New Drug Application		An application with a 6-month FDA review performance goal for a product determined to provide a significant therapeutic or public health advance.
Prisoner (in terms of Subject)		An individual involuntarily confined in a penal institution, including persons: 1.) sentenced under a criminal or civil statue; 2.) detained pending arraignment, trial, or sentencing; and 3.) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution.	45 CFR 46.303(c)
Prisoner Representative (in relation to IRBs)		A member of an IRB who has appropriate background and experience to represent the interests and concerns of an individual who is involuntarily confined to an institution.
Privacy		Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Privacy Board (in relation to HIPAA)	PB	A board that is established to review and approve requests for waivers or alterations of authorization in connection with a use or disclosure of PHI as an alternative to obtaining such waivers or alterations from an IRB.
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).
Proband		The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic.
Probability		A number expressing the likelihood of occurrence of a specific event.
Procedure		Something done to fix a health problem or to learn more about it. For example, surgery, tests, and putting in an IV (intravenous line) are procedures.
Process		The goal-directed, interrelated series of actions, events, mechanisms, or steps.
Process Improvement		A methodology utilized to make improvements to a process through the use of continuous quality improvement methods.
Process Indicator		A gauge that measures a goal-directed interrelated series of actions, events, mechanisms, or steps.
Product Development Protocol (in relation to Medical Devices)	PDP	A contract between sponsor and FDA that describes the agreed upon details of design and development activities of a device (i.e., Class III devices subject to pre market approval [PMA]), the outputs of these activities, and acceptance criteria for these outputs.	http://www.fda.gov/cdrh/pdp/420.html
Product License Application	PLA	1.) (US) The compilation of all information and data about a biological product which is submitted to the FDA for review. The FDA must approve the PLA before a biologic can be marketed in the US. 2.) Historical term for an application for a new biological product submitted to the FDA, specifically CBER, under the Public Health Service Act for review and approval prior to marketing in interstate commerce.
Productivity Investments		Spending aimed at increasing contractor operational efficiency and productivity through improved work methods, application of technology, etc.
Profiles		Data segregated by specific time period (e.g., quarterly, annually) and target area (e.g., facility, State) for the purpose of identifying patterns.
Prognostic Factors		Subject information that enables a physician to predict response to therapy. This information is documented at entry into the trial. In comparative studies, it is preferable that treatment groups are similar with respect to prognostic factors such as age, sex, clinical history, concomitant therapies, etc.
Program Announcement (in relation to NIH)	PA	An announcement by an institute or center requesting applications in the stated scientific areas.
Program Director (in terms of NIH)		See Principal Investigator (in terms of NIH)
Program Official (in terms of NIH)		The National Institutes of Health official responsible for the programmatic, scientific, and/or technical aspects of a grant.
Programmed Research Information System at Michigan	PRISM	The PRISM database contains administrative and financial data on proposals and awards processed by DRDA. All proposals and awards are keyword coded, enabling searches on the sponsored activities of the faculty.	http://cgi.research.umich.edu/ prism/pow.lasso
Program for Research Integrity Development & Education	PRIDE	New Veterans Administration (VA) office whose mission is to protect participants in VA human research who's responsible for all policy development and guidance, and all training and education in human research protection throughout the VA.	http://www1.va.gov/resdev/fr/PRIDE/
Project		A protocol or grant involving human subject research.
Project Award Change	PAC	Project Award Change forms are distributed by DRDA to identify any changes in terms and conditions, additional funding, time extensions, and other modifications after an award notice goes out. The PAC form indicates the reason for the modification, with reference to the sponsor notification regarding the change, and notes any additional reporting requirements, changes to project duration (e.g., as a result of a "no cost time extension"), and funding changes.
Project Award Notice	PAN	A Project Award Notice is prepared and distributed by DRDA to the Principal Investigator and serves to establish the project/grant number for the project. Special terms and conditions of the award are identified, including cost-sharing commitments, and key personnel responsible for assisting in the administration of the project are listed on the PAN.
Project Director (in terms of NIH)		See Principal Investigator (in terms of NIH)
Project Officer (in terms of NIH)		A National Institute of Health staff member who coordinates the substantive aspects of a contract from planning the request for proposal to oversight
Prophylactic		Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.
Proposal		The written description of a project which is presented to a sponsor; the proposal includes cost estimates and other administrative details, in addition to a statement of work.
Proposal Approval Form	PAF	University of Michigan form that must be routed with proposals through the University and signed by university officials	http://www.research.umich.edu/proposals /forms/forms.html#PAF
Proprietary Interest in the Tested Product		Property or other financial interest in the product including, but not limited to, a patent, trademark, copyright or licensing agreement.	21 CFR 54.3
Pros and Cons		The good and bad parts of treatment for a health problem. For example, a medicine may help your pain (pro), but it may cause an upset stomach (con).
Prospective Study		Investigation in which a group of subjects is are recruited and monitored in accordance with criteria described in the protocol.
Prospect of Direct Benefit		The basis of scientific evidence, a realistic possibility exists that some subjects physical, medical or mental conditions and related functioning might be improved as a direct result of participation in research, including ameliorating symptoms or avoiding side effects of standard therapy.
Protected Health Information (in relation to HIPAA)	PHI	Individually identifiable health information transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium. It excludes some education and employment records held by a covered entity in its role as employer.
Protection of Pupil Rights Amendment	PPRA	Department of Education regulation that states that surveys, questionnaires and instructional materials for school children must be inspected by parents/guardians.
Protocol		A formal written document which states the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.	ICH E6 1.44
Protocol Addendum		See Protocol Amendment
Protocol Amendment		1.) A formal written document detailing changes to a protocol that has been approved by the relevant regulatory authorities and HSRCs. 2.) Also refers to the addition of a study protocol not submitted in the original IND application. 3.) A written description of a change(s) to or formal clarification of a protocol.	ICH E6 1.45
Protocol Deviation		1.) An event occurring in a study which is not in compliance with the requirements of the protocol and for which an amendment has not been granted. 2.) Generally considered to be lesser deviation from the protocol violation. See also Protocol Violation
Protocol Modification		See Protocol Amendment
Protocol Number		The sponsor-specific number assigned to an individual clinical trial.
Protocol Review Committee		An internal group within an institution or company which reviews trial proposals for completeness, compliance, and feasability
Protocol Signature Sheet		A document for the investigator and/or sponsor agreement to the protocol and/or amendments	ICH E6 8.2.2
Protocol Violation		Failure by the investigational team or the subject to follow any aspect of the protocol, during the course of a clinical study. See also Protocol Deviation
Protocol Violator		A study subject in a clinical trial who does not conform to the operating features of that trial as set out in the protocol.
Proxy		An index of known values that likely approximates an index for which values are unavailable. The proxy is used as a "stand-in" for the unavailable index.
Publication		1.) Journal articles, books, or book chapters as well as abstracts, posters, and presentations at scientific and professional meetings. 2.) A means (e.g., peer reviewed journal) for publishing information about the interim or final results of a clinical trial.
Public Health Service	PHS	A principal part of the Department of Health and Human Services (HHS) and the major health agency of the United States government consisting of eight major agencies which include the Food and Drug Administration, National Institutes of Health, and Centers for Disease Control and Prevention
Public Key Infrastructure	PKI	A system of public key encryption using digital certificates from Certificate Authorities and other registration authorities that verify and authenticate the validity of each party involved in an electronic transaction. PKIs are currently evolving and there is no single PKI nor even a single agreed-upon standard for setting up a PKI. However, nearly everyone agrees that reliable PKIs are necessary before electronic commerce can become widespread.
Public Relations	PR	The art or science of establishing and promoting a favorable relationship with the public. OR, The methods and activities employed to establish and promote a favorable relationship with the public.
Public Responsibility in Medicine and Research	PRIM&R	A United States-based organization committed to the advancement of strong research programs and to the consistent application of ethical precepts in both medicine and research.	http://www.primr.org/
Pulmonary Function Tests	PFT	A test designed to measure how well the lungs are working. PFTs gauge how the lungs are carrying out their tasks -- of expanding and contracting (when a person inhales and exhales) and of exchanging oxygen and carbon dioxide efficiently between the air (or other gases) within the lungs and the blood. For example, one pulmonary function test calls for the patient to breathe into a machine called a spirometer. It is a mechanical device that records the changes in lung size as air is inhaled and exhaled and the time it takes for the patient to do this task.
Purchase Order	PO	A purchase order may be the authorizing document for a contractual arrangement used to pay consultants if they have an IRS employer ID number.
Pure Food and Drug Act of 1906		(US) This law prohibits interstate commerce in adulterated foods and drugs. It was written in response to the growing concerns over the public's exposure to inferior substitute and harmful substances in food and drug products.
Purity		The relative absence of extraneous matter in a drug or vaccine that may or may not be harmful to the recipient or deleterious to the product.
Q
Qualitative Variable		One that cannot be measured numerically (race and sex, for example).
Quality		Quality is how well the health plan keeps its members healthy or treats them when they are sick. Good quality health care means doing the right thing at the right time, in the right way, for the right person and getting the best possible results.
Quality Assurance