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Senior Associate Regulatory Analyst

Scheduled Continuing Review (SCR)

SCRs are completed through eResearch and are required to be submitted and approved prior to expiration. See also Continuing Review.

Sequence Number

Sponsor-provided subject identifier for this clinical trial


  • Refers to the outcome of an adverse event.
  • An event is "serious" if it adversely alters the risk-benefit relationship of the research.

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any adverse experience occurring at any dose or level of participation that results in any of the following outcomes:

  • Results in death,
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization,
  • Results in persistent or significant disability/incapacity, or
  • Is a congenital anomaly/birth defect.
  • An unexpected result of therapy or other intervention that is severe, life threatening, or fatal, corresponding to grades III, IV, or V using NCI/CTC Common Toxicity Criteria.

Serious Non-Compliance

Non-compliance that has the potential to increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human subjects protection program. Examples of serious noncompliance may include, but are not limited to: conducting or continuing non-exempt human subjects research without IRB approval; lack of legally effective informed consent from research participants; failure to report or review serious adverse events, unanticipated problems, or substantive changes in research; or inappropriate oversight of the research to insure the safety of human subjects and the integrity of the research/data.

Severe Social or Psychological Trauma

Loss of job, insurance, benefits; criminal prosecution, stigmatization of community/group, destruction of familial/social relations.

Severe-Serious Distinction

Serious adverse events result in death, disability, hospitalization (or prolongation of a hospital stay), or birth defects. Therefore, an adverse event that in and of itself would be graded as mild or moderately-severe becomes a serious adverse event if it leads to one of those outcomes. For example, a case of myelosuppression could require prolongation of an existing hospitalization, making it a "serious AE" for reporting purposes even if the myelosuppression was itself only moderately severe (Grade II). Compare to a subject experiencing a migraine after a hormone injection-the patient might consider the migraine to be severe, but if it did not result in hospitalization or other serious problems, it is not reported as a serious adverse event. See Serious Adverse Event and Severity.

Severely Debilitating

Refers to diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of limb, loss of hearing, paralysis, or stroke).


An assessment regarding the intensity of an Adverse Event (rating the event mild, moderately severe, severe, life threatening or fatal; or Grade I, II, III, IV or V).

Short Form

A written document stating that the elements of informed consent required by regulation have been presented orally to the participant or the participant's legally authorized representative. The short form consent document must be written in a language understandable to the participant or the participant's legally authorized representative.

Short Title

A study requires a short title in OnCore which involves the reduction of the full study title to a logical description that is no more than 100 characters. ***It is necessary to include RESEARCH, at the beginning of the title. Including this prefix is required, as it drives the downstream MiChart billing process.*** The Short Title is the description displayed in several OnCore reports such as Data Table 4 for cancer centers.


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."


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.


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.


Standard Operating Procedure


Single Project Assurance


University of Michigan Standard Practice Guide


  • 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)


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)


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.


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


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.


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.


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.