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CR

 Continuing Review; CRs are completed through eResearch and are required to be submitted and approved prior to expiration; see also SCR

CRAO

the Clinical Research Calendar Review Analysis Office, formerly the Clinical Research Billing Unit (CRBU)

CRF

Case Report Form

Cross-Over Design

A type of clinical trial in which each subject experiences, at different times, both the experimental and control therapy. For example, half of the subjects might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.

CTSA

Clinical and Translational Science Award

CTSU Coordinator

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

CTSU Intake Approval Date

The date the CTSU intake form was received via email.

CTSU Intake No.

Sequential number followed by the PI's last name automatically assigned at the time of intake form submission.

Custom Device

A device that necessarily deviates from devices generally available or from an applicable performance standard or pre-market approval requirement to comply with the order of an individual physician or dentist and that is: 

  • Not generally available or generally used by other physicians or dentists;
  • Not generally available in finished form for purchase or for dispensing upon prescription;
  • Not offered for commercial distribution through labeling or advertising; and
  • Intended for use by an individual patient named in the order of a physician or dentist and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.

Data

When data is anonymous, they are not linked to the identity of individual subjects in any way that would make it possible to connect the information to the individual from whom it came. Anonymous data does NOT have direct identifiers like names, addresses, clinic or hospital number, Social Security Number, or insurance agency numbers. Data that is linked to subjects via a CODE are NOT anonymous. When data is confidential, there is a link between data and the individuals who provide it, but the link is obscured by coding or other procedures so that even someone who has access to the raw data cannot identify a subject without also having access to the link between the subject code and the subject's identity.

Data and Safety Monitor

An individual assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. The individual should have expertise in the relevant medical, ethical, safety and scientific issues.

Data and Safety Monitoring Board (DSMB)

An appointed independent group consisting of at least three (3) members assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. Membership should include expertise in the relevant field of study, statistics, and research study design. Also known as a Data and Safety Monitoring Committee (DSMC).

Data and Safety Monitoring Plan (DSMP)

A defined process to protect the safety of human subjects and maintain the scientific integrity of human subject research and the validity of the data. A DSMP may be a stand-alone document or the section of a protocol that describes the steps to identify physical, social, or psychological occurrences that may result from participation in the research study and explains in detail how such occurrences will be handled and reported. A DSMP describes the timing, tools and/or method(s) for monitoring and evaluation, procedures for treatment or resolution (including circumstances which would result in halting or terminating research). It includes procedures for and timing of reports to oversight bodies, and description of oversight bodies involved with the study (e.g., study team, FDA, IRB, or DSMB). It describes the frequency with which each oversight group reviews the collected information. A study does not need to have a DSMB to have a DSMP.  The purpose of a DSMP is to minimize risks for subjects to the extent possible by explicating procedures for monitoring their safety. A DSMP would formalize action items such as:

  • methodology for notifying an attending physician of emergent events
  • obtaining psychiatric consults for findings of likely suicide
  • procedures and education for staff regarding protection of private information
  • procedures to follow when subjects experience significant social or emotional upset in response to the research interaction (e.g., a panic attack after an interview and questionnaire)

Note that data collected for safety monitoring (or for research purposes) does not necessarily have to be submitted to IRB as an adverse event report.

Data Points

Any text or numbers generated during a study.

Data Use Certification (DUC)

A DUC is the application a user submits for consideration for authorized use of controlled dbGaP data. The DUC should include a list of the controlled data set(s) required by the user and a brief description of the proposed research use of the requested data. The user must also offer the following assurances in the DUC that:

  • the data will only be used for approved research;
  • data confidentiality will be protected;
  • all applicable laws, local institutional policies, and terms and procedures specific to the study's data access policy for handling dbGaP data will be followed;
  • no attempts will be made to identify individual study participants from whom data were obtained;
  • controlled-access data from dbGaP will not be sold or shared with third parties;
  • the contributing investigator(s) who conducted the original study and the funding organizations involved in supporting the original study will be acknowledged in publications resulting from the analysis of those data;
  • all NIH supported genotype/phenotype data and conclusions derived directly from them will remain in the public domain, without licensing requirements;
  • an annual research progress report will be submitted.

The completed DUC must be co-signed by a designated official representing the institution for which the applicant works.

Database of Genotypes and Phenotypes (dbGaP)

dbGaP was developed to archive and distribute the results of studies that have investigated the interaction of genotype and phenotype. Such studies include genome-wide association studies, medical sequencing, molecular diagnostic assays, as well as association between genotype and non-clinical traits. The advent of high-throughput, cost-effective methods for genotyping and sequencing has provided powerful tools that allow for the generation of the massive amount of genotypic data required to make these analyses possible.

dbGaP

database of Genotypes and Phenotypes

De-identified

All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s). For purposes of the HRPP policy, health information is de-identified when it does not contain any of the 18 identifiers specified by the HIPAA Privacy Rule at 45 CFR 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule)

Dead Fetus

An expelled or delivered fetus that exhibits no heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of the umbilical cord (if still attached) [45 CFR 46.203(f)]. Generally, some organs, tissues, and cells (referred to collectively as fetal tissue) remain alive for varying periods of time after the total organism is dead.

Dean

Dean of the Medical School

 

Death

Reports generally refer to the death of a research subject but also death of another (a person not enrolled in the study) that is definitely, probably, or possibly related to the study must be reported (e.g., in a study of anti-psychotic medications, the study drug is found to increase irritability and the research subject commits murder).

Debriefing (in Research)

Giving subjects previously undisclosed information about the research project following completion of their participation in research.

Deception

The intentional misleading of a subject about the nature of the study. Deception increases ethical concerns and should be used with discretion, because it interferes with the ability of the subject to give informed consent. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental. The IRB recognizes that deception or concealment may be necessary for certain types of behavioral research. Because people act differently depending on circumstances, full knowledge by the subject might bias the results in some cases.

Declaration of Helsinki

A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries.  The fundamental principle is respect for the individual, their right to self-determination and the right to make informed decisions regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient or volunteer, and while there is always a need for research, the subject's welfare must always take precedence over the interests of science and society, and ethical considerations must always take precedence over laws and regulations. The recognition of the increased vulnerability of individuals and groups calls for special vigilance. It is recognized that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor, then allowance should be considered for surrogate consent by an individual acting in the subject's best interest, in which case their assent should still be obtained if at all possible.

Deferred

An IRB action that specifies conditions under which research can be reconsidered for approval, pending substantive clarifications or modifications to the protocol and/or informed consent process/document, without which the IRB could not fully evaluate the research under review.

Definitely related adverse event

An adverse event that         

  • is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including IB, consent, publications)
  • follows an obvious sequence of time, from the drug’s administration, device’s implantation or activation, or procedure, for which the event is directly attributed to the administration, implantation, activation, or procedure
  • ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting)
  • includes data that was only collected for the study
  • included disturbing or upsetting questions that the subject was asked for the purpose of the research

Department

Principal Investigator’s Department of Primary Appointment.

Department of Health and Human Services (DHHS)

Federal Department of Health and Human Services; see also HHS

Deviation

An incident involving noncompliance with the protocol, but one that 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 participant, researcher, or staff.

Diminished Decision-Making Capacity

In informed consent: lacking the ability to provide valid informed consent to participate in research, e.g., as a result of trauma, intellectual disability, certain mental illnesses, cognitive impairment, or dementia. Diminished decision-making capacity may be temporary, permanent, progressive, or fluctuating.

Direct Sponsor

The organization entering into the agreement with UM to perform work on the project. Every project has a Direct Sponsor

Disapproved (Decision)

An IRB action taken when the determinations required for approval of research cannot be made, even with substantive clarifications or modifications to the protocol and/or informed consent process/document.

DOD

Department of Defense

Dose Limiting Toxicity (DLT)

Size-effects severe enough to prevent giving more of the treatment.

Dose-Ranging Study

A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful.

Double-Blind Study

A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.

Double-Masked Design

A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects. Sometimes referred to as "double-blind."

DRDA

Division of Research Development and Administration of the University of Michigan Office of the Vice President for Research

Drug-Drug Interaction

A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.

DSC

 Data Safety Committee

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