Research A to Z

Case Report Form

Clinical and Translational Science Award

The date the CTSU intake form was received via email.

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.

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.

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.

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

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.

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).

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.

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.

Principal Investigator’s Department of Primary Appointment.

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.

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

Department of Defense

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.

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."

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.