1 | 2 | 4 | 5 | 7 | A | B | C | D | E | F | G | H | I | J | L | M | N | O | P | Q | R | S | T | U | V | W

CareWeb

A web-based clinical patient record system (which has been replaced by the MiChart system) that provided rapid access to patient data from a wide variety of clinical systems, including lab, radiology, medical records and others. See MiChart.

Case Report Form (CRF)

A paper or electronic questionnaire specifically used in clinical trial research. The CRF is the tool used by the sponsor of the clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.

Case-control Study

A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors. See also: Retrospective Studies

Cause

An assessment made by the investigator and/or sponsor regarding the proper attribution of an adverse event. Examples: Study intervention (e.g., drug, device, or therapy); Concurrent non-research therapy; Disease progression; Other or unknown source.

CDC

Centers for Disease Control

Central Institutional Review Board (CIRB)

The CIRB is designed to help reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. A local IRB's use of the CIRB facilitated review mechanism enables an investigator to enroll patients into studies significantly faster than when employing traditional method of IRB review.

Certificate of Confidentiality (CoC)

Certificates of Confidentiality are issued to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local. Certificates of Confidentiality protect subjects from compelled disclosure of identifying information but do not prevent the voluntary disclosure of identifying characteristics of research subjects. Researchers, therefore, are not prevented from voluntarily disclosing certain information about research subjects, such as evidence of child abuse or a subject's threatened violence to self or others. However, if a researcher intends to make such voluntary disclosures, the consent form should clearly indicate this.

Certified Translation

A certified translation is one that has been formally verified by a licensed translator or translation company for use in official purposes. Certified translators attest that the target-language text is an accurate and complete translation of the source-language text. Certified translation of consent documents ensures that the tone, meaning and content of the translated documents remain consistent with the IRB-approved English version.

CFR

the United States Code of Federal Regulations

Chair(s)

The IRBMED Chair, Co-Chair(s), and Vice-Chair(s) of the Board

Children

Persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. In Michigan, the legal age is 18 years old with some exceptions.

CIRB

Central Institutional Review Board

Class I, II, III Devices

Classification by the FDA of medical devices according to degree of potential risks or hazards.

Clinical and Translational Science Award (CTSA)

Working together as a national consortium, at least 60 CTSA institutions have committed to improve human health by streamlining science, transforming training environments and improving the conduct, quality and dissemination of clinical and translational research. The CTSA program is part of the NIH.

Clinical Investigator

A clinical investigator involved in a clinical research project is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The qualifications must be outlined in a current resume and readily available for auditors.

Clinical Research Associate

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

Clinical Research Calendar Review Analysis Office (CRAO)

The mission of CRAO is to complete analysis for all human subject research that have billable items and services to assure consistency and to allow for the appropriate adjudication of charges. CRAO supports and collaborates with researchers and study teams to produce a uniform process for the Research Billing Calendar, Budget and Enrollment. CRAO ensures the Clinical Research Billing process is utilized throughout the research continuum and ensuring that UM is compliant.

Clinical Research Nurse

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

Clinical Trial

  • A prospective study involving human subjects designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions; these may include drugs, treatments, surgical procedures, devices, behavioral or nutritional strategies. Clinical trials are typically conducted by investigators who have entered into an agreement with a sponsor to conduct the study. For clinical drug and device trials, investigators agree to conditions regarding the conduct of the study outlined by FDA.
  • A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (hyperlink each Phase)

Not all human subject research projects are ‘clinical trials’.

Close out

A study that no longer has active subjects.

CMS

Centers for Medicare and Medicaid Services

Co-I

Co-Investigator; see also Sub-I (Sub-Investigator)

Co-investigator (Co-I)

Any individual member of the clinical trial team designated and supervised by the principal investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions. See also Investigator

CoC

 Certificate of Confidentiality

Code of Federal Regulations (CFR)

The CFR is a codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles representing broad areas subject to Federal Regulation. Each Title is divided into chapters that are assigned to agencies issuing regulations pertaining to that broad subject area. Each chapter is divided into parts and each part is then divided into sections -- the basic unit of the CFR. The purpose of the CFR is to present the official and complete text of agency regulations in one organized publication and to provide a comprehensive and convenient reference for all those who may need to know the text of general and permanent Federal regulations.

Coded

Direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these (not derived from or related to the personal information) for purposes of protecting the identity of the source(s), but the original identifiers are retained in such a way that they can still be traced back to the source(s).

Coercion

Persuasion (i.e., of an unwilling person) to do or agree to something by using obvious or implied force or threats.

Cognitively Impaired

A person having a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from post-traumatic or degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests. See the UM HRPP Operations Manual, Part 7 for details on UM policies regarding these subjects.

Cohort

A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.

Cohort Study

A form of longitudinal study used in medicine and social science

COI

a conflict of interest, and may consist of a financial conflict of interest or a conflict of commitment; it includes both actual and perceived conflicts of interest

Collaborating Entities

Entities engaged in human subject research by virtue of subject accrual, transfer of identifiable information, and/or in exchange of something of value, such as material support (e.g., money, drugs, or identifiable specimens, co-authorship, intellectual property, or credits).

Common Rule

The ‘Common Rule’ is the Federal Policy for the Protection of Human Subjects, as set forth in 45 CFR 46 subpart A, and parallel regulations promulgated by agencies such as the FDA.

Common Rule

the Federal Policy for the Protection of Human Subjects, as set forth in 45 CFR 46, subpart A, and parallel regulations promulgated by agencies such as the Food and Drug Administration (FDA)

Common Terminology Criteria for Adverse Events (CTCAE)

Is designed as an instrument to be used to document AEs identified through a combination of clinical and laboratory evaluation. CTCAE is NOT a tool to assist with data extraction from source documents without the direct participation and supervision of clinical investigators. AE grading and attribution require documentation by medical personnel who are directly involved in the clinical care of protocol subjects.  Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term.                                  

Grade is an essential element of the Guidelines and, in general, relates to severity for the purposes of regulatory reporting to NCI as follows: Grade Description: 0: No AE (or within normal limits). 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. 2: Moderate; minimal, local, or noninvasive intervention (e.g., packing, cautery) indicated; limiting age-appropriate instrumental activities of daily living. 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. 4: Life-threatening consequences; urgent intervention indicated. 5: Death related to AE.

A severe AE, as defined by the above grading scale, is NOT the same as serious AE which is defined in Section 2.1.22 (FDA, 21 CFR 312.32; ICH E2A and ICH E6).

Compassionate Use

  • A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy.
  • Use of an investigational drug or biologic or unapproved medical device for a single subject (or small group of subjects) with a serious disease or condition, who does not meet the requirements for inclusion in a clinical investigation, and for whom no standard acceptable treatment is available. Prior FDA and IRB approval are required for compassionate use.

Note: The terms compassionate use and emergency use are not synonymous.

Compensation

Payment, merchandise, class credit, or other gift or service provided to research participants or their legally authorized representatives to reimburse them for their time, effort, and/or for any out-of-pocket expenses associated with research participation. Compensation is sometimes distinguished from an incentive or inducement, which is generally thought of as a payment or other offering that is “over and above” reimbursement and intended to encourage research participation.

Competence

A legal term used to denote capacity to act on one’s own behalf. The ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Competence may fluctuate as a function of the natural course of a mental illness, response to treatment, effects of medication, general physical health and other factors. Therefore, mental status should be reevaluated periodically. As a designation of legal status, competence or incompetence pertains to an adjudication in court proceedings that a person’s abilities are so diminished that his or her decisions or actions (e.g., writing a will) should have no legal effect. Such adjudications are often determined by inability to manage business or monetary affairs and do not necessarily reflect a person’s ability to function in other situations.

Competing Proposals

Proposals that are submitted for the first time or unfunded proposals that are resubmitted; either must compete for research funds. Ongoing projects must compete again if the term of the original award has expired.

Competing Protocols

List competing protocols by entering their protocol numbers and clicking the Add button. If there are no competing protocols, check the No Competing Protocol? checkbox.

Pages