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SHUR

University Subcommittee on the Human Use of Radioisotopes

Side Effects

Any undesired actions or effects of a drug or treatment. Negative or AE may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. See also Adverse Event.

Significant Risk (SR) Device

An investigational device that is:

  • Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
  • For use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject;
  • For a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
  • Otherwise presents a potential for serious risk to a subject.

Single-Blind Study

A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study. See Blind and Double-Blind Study.

Single-Masked Design

Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-blind design."

Site

This term refers to the location of the responsible oversight investigator and IRB. If the event occurred on a study directed/supervised by UM faculty or staff, it is local.

SMR

Single Member Review

Social or Psychological Trauma

Harm, insult, or injury affecting social status or standing, or relationships, or psychological health/well-being. Such harms include but are not limited to: invasion of privacy; breach of confidentiality; significant embarrassment; stigmatization; anxiety; fear; effects of stereotyping; loss of insurance or other benefits; criminal prosecution; effects on employment including job loss or demotion; interruption, disruption, or destruction of familial/social relations.

SOP

Standard Operating Procedure

SPA

Single Project Assurance

SPG

University of Michigan Standard Practice Guide

Sponsor

  • The company/person who initiates the study. The sponsor is typically the manufacturer or research institute that developed the drug or device. In this case, the sponsor does not actually conduct the clinical trial but rather distributes the investigational drug or device to clinical investigators who direct local conduct of the trial. A clinical investigator may, however, serve as both the sponsor and investigator (investigator-sponsor) of a clinical trial. The sponsor assumes general responsibility for the studies involving the investigational drug or device, including responsibility for compliance with applicable laws and regulations. The sponsor is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.
  • A person or other entity that initiates a clinical investigation, but that does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than that individual (e.g., a corporation or an agency) that uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators. (FDA)

Sponsor-Investigator

An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any person other than an individual, e.g., it does not include a corporation or agency. The obligations of a sponsor-investigator under this part include both those of a sponsor and those of an investigator. (FDA)

SSDI

Social Security Death Index

Standard of Care

Is a medical or psychological treatment guideline, and can be general or specific. It specifies appropriate treatment based on scientific evidence and collaboration between medical and/or psychological professionals involved in the treatment of a given condition. Some common examples include: treatment standards applied within public hospitals to ensure that all patients receive appropriate care regardless of financial means; or treatment standards for gender identity disorders

Start Up

Activity on a study that is not open to accrual.

Stipulation(s)

Express IRB provisions that must be satisfactorily addressed before a human subject research project can be approved and any involvement of human subjects in the research may begin. Under no circumstances do stipulations constitute contingent approval of the research project—approval is neither given nor implied until the PI has received written notice of IRB approval.

Study Completion Date

Final date on which data is expected to be collected at U-M.

Study Drug

The drug under investigation in a research study (includes approved and unapproved drugs).

Study Endpoint

A primary or secondary outcome used to judge the effectiveness of a treatment.

Sub-I

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

Subject

An individual who participates in research, either as a recipient of the investigational product (s) or as a control. Individuals can be the subject of research without being aware of their participation when informed consent is waived.

Subject Confidentiality

Right and understanding of a subject that private data or protected health information will be divulged only as noted in the informed consent document, and/or as necessary for subject's health and safety, and/or as necessary by law. Investigators should take steps to protect subjects' confidentiality including where appropriate removal of patient specific identifiers (patient name, registration number, social security number, etc.) in reports to the IRBMED. Subject initials, unique coding specific to a study, and/or age are acceptable alternatives to names and registration numbers in IRBMED reports, and useful in correlating subject/patient specific information.

Subject Related

Subject-related events are attributable to a specific subject and are associated with specific visits.

Survey Studies

Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.

Suspended

A study may be suspended for many reasons. Different parts of the study can be suspended, i.e., recruitment or all study activities.  The suspension can be required by the Sponsor or the IRB, or the PI can voluntarily suspend the study.

Suspension

An action taken by the IRB Chairs, Vice Chairs, or convened IRBs to withdraw approval for some research activities, temporarily or permanently, or all research activities temporarily, short of permanently withdrawing approval for all research activities. The Institutional Official may also suspend research on an urgent basis.

SVS (Single Shell Visit)

MBECT Single Visit Shell, utilized to generate the RSH / populate allowable procedures until the CRPC interface is loaded into OnCore.

Tabled

An IRB “action” that indicates that review was not initiated or was not completed, resulting in postponement of convened IRB review, usually due to loss of quorum or other administrative issue. Research tabled at a convened meeting will be reviewed at a future convened meeting.

Task List Completed Date

The date the document was actually received and attached to the protocol in OnCore, or the date the activity was actually completed. It is important to track these dates so that tasks

are marked as completed and do not show up in the Active or Upcoming Task widgets in the OnCore dashboard.

Task List Owner

The person (or role) responsible for completing the task. This may be a particular person (user) in OnCore or a role (such as CTSU Coordinator), which allows any user in that role (with access to the protocol) to be notified about Active or Upcoming Tasks.

Task List Target Date

The expected date the document will be received and attached, or the activity will be completed. It is recommended these dates are completed when the task list is first applied to the protocol.

Technology Transfer (Tech Transfer)

Tech Transfer is a process involving assessing an invention disclosure (technology), patenting the technology, marketing and finally licensing the technology or forming start-up companies based on technology.

Terminated

A study may be Terminated for many reasons. Different parts of the study can be terminated, i.e., recruitment or all study activities.  The termination can be required by the Sponsor or the IRB, or the PI can voluntarily suspend the study.

Termination

An action taken by the convened IRBs to permanently withdraw approval for all research activities (except for those follow-up procedures that may be necessary to protect the health and/or welfare of participants). This may occur on a particular study or on all studies where an investigator is named PI.

Test Article

Any drug, biological product, medical device, human food additive, color additive, electronic product, or any other article under investigation in a research study (included approved and unapproved drugs, biologics and devices).

Therapeutic Intent

The research physician’s intent to provide some benefit to improving a subject’s condition (e.g., prolongation of life, shrinking of tumor, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected). This term is sometimes associated with Phase I drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the patient’s condition, as well as assessing the safety and pharmacology of a drug.

Therapeutic Misconception

Research participant's belief that enrolling in a research study will provide therapeutic benefit. Participants confuse the goal of clinical therapy which is to provide benefit to the individual patient and where any new knowledge gained is incidental and the goal of research which is to gain knowledge to help future patients (generalizable) and where therapeutic benefit to individual maybe secondary.

Therapeutic Research

Research involving an intervention that has the likelihood of providing a therapeutic, diagnostic or preventive benefit to the subjects.

Title

Equivalent to the U-M Full Title in the eResearch Proposal Management system; ultimately, this should be the title as found exactly on the contract. Entries must be 4000 characters or less.

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