S

Safety Report

Alert issued to inform researchers using same the pharmacological compound about unanticipated, serious, negative experience in patients/participants who are not necessarily enrolled as subjects on a given study. These reports usually are issued by the US FDA or by a drug/device manufacturer.

Salaries and Wages

Payments made to employees of the institution for work performed.

Sample

Human biological material, including solid material (e.g., tissue, organs) body fluid (e.g., blood, urine, saliva, semen, cerebrospinal fluid), and cells.

Scheduled Continuing Review (SCR)

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

Scientific Misconduct

Fabrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted within the academic community for proposing, conducting or reporting research.

Scientific Review Group

A group of highly regarded experts in a given field, convened by NIH to advise NIH on the scientific merit of applications for research grants and contracts. Scientific review groups are also required to review the ethical aspects of proposed involvement of human subjects. Various kinds of scientific review groups exist, and are known by different names in different institutes of the NIH (e.g., Study Sections).

Scope of Work

The description of the work to be performed and completed on a research project. Also referred to as "Statement of Work".

Screening Trials

Refers to trials which test the best way to detect certain diseases or health conditions.

Secretary

A US Cabinet Officer. In the context of DHHS-conducted or -supported research, usually refers to the Secretary of Health and Human Services.

Senior Associate Dean

Senior Associate Dean is the Medical School Senior Associate Dean for Research

Senior Personnel

Professional personnel who are responsible for the scientific or technical direction of project.

Serious

• 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

Any adverse experience occurring at any dose or level of participation that results in any of the following outcomes: death, a life-threatening experience, hospitalization or prolongation of existing hospitalization, a persistent or significant disability or capacity, or a congenital anomaly or birth defect.

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

• Any untoward occurrence that:
• 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.

Severely Debilitating

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

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 Severe, and Severity.

Severity

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.

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.

Site Visit

A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research.

Small Business Administration
(SBA)

The US Small Business Administration, established in 1953, provides financial, technical and management assistance to help Americans start, run, and grow their businesses.

Small Business Innovative Research (SBIR)

Agency administered programs supported by ear-marked federal funds, making grants to small business entities.

Small Business Technology Transfer (STTR)

Grant applications and/or programs to fund small business "teamed" with research institutions.

Small Grant

A special type of award, often limited to a beginning researcher. Typically, such an award may be obtained for one year only.

Social Experimentation

Systematic manipulation of, or experimentation in, social or economic systems; used in planning public policy.

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.

Social Security Administration

Social Security Administration is a federal agency whose mission is to promote the economic security of the nation’s people through compassionate and vigilant leadership in shaping and managing America’s social security programs. Virtually all of SSA’s administrative resources are committed to the management of three major programs: the Old Age and Survivors Insurance (OASI) program, the Disability Insurance (DI) program, and the Supplemental Security Income (SSI) program.

Social Security Death Index (SSDI)

The SSDI is a database of death records created from the US Social Security Administration's Death Master File Extract. Most persons who have died since 1962 who had a Social Security Number (SSN) and whose death has been reported to the Social Security Administration are listed in the SSDI. For most years since 1973, the SSDI includes 93 percent to 96 percent of deaths of individuals aged 65 or older. The SSDI currently contains the records of over 84 million people and is available free online. The SSDI is a popular tool for genealogists and biographers because it contains valuable genealogical data. The data includes: Given name and surname; and since the 1990s, middle initial; Date of birth; Month and year of death; or full date of death for accounts active in 2000 or later; SSN; State or territory where the SSN was issued; Last place of residence while the person was alive ZIP code. Once a deceased person is found in the database, the person's application for Social Security card can be ordered from the Social Security Administration. This contains additional genealogical data, such as birth place, father's name, and mother's full maiden name.

Society of Clinical Research Associates (SoCRA)

SoCRA’s mission is to provide training, continuing education, and an internationally recognized certification program that promote quality clinical research to protect the welfare of research participants and improve global health.

Society of Research Administrators
(SRA)

Founded in 1967, the SRA International is a nonprofit association dedicated to advancing the profession and improving the efficiency and effectiveness of research administration.

Special Purpose Equipment

Permanent equipment which is usable only for research, medical, scientific, or technical activities. Examples include microscopes, x-ray machines, surgical instruments and spectrometers.

Specimen

Human biological material, including solid material (e.g., tissue, organs) body fluid (e.g., blood, urine, saliva, semen, cerebrospinal fluid), and cells.

SPIN Matching and Researcher Transmittal System
(SMARTS)

An electronic matching and funding opportunity notification which provides investigators with a direct and targeted electronic link to funding information via e-mail.

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)

Sponsored Programs Information Network (SPIN)

An on-line search system available by subscription for research opportunities developed by the InfoEd.

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)

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

Standard Operating Procedures (SoPs)

In clinical research, SOPs are defined as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs are necessary to achieve maximum safety and efficiency of the clinical research operations. It is a must that all have appropriate SOPs in place in order to conduct clinical research and to ensure compliance with the current regulations.
The ICH GCP Guideline suggests that IRBs have their own SOPs. This proves that the presence of SOPs is an integral part for all levels. The presence of SOPs is essential when inspections take place since the most frequent reported deficiencies during inspections are the lack of written SOPs and/or the failure to adhere to them. The risk of GCP non-compliance is high at organizations with a poor availability of clinical research specific SOPs and also if at all they are available the staff or the people for whom they were written are not either aware of them or their need. It is therefore very important for training on the SOPs so all are aware of why and how SOPs can play important role in fulfilling the regulatory requirements.

Standard Practice Guide (SPG)

The SPG is furnished to provide employees with convenient access to the operating policies and practices of the various departments, facilities, and services that are available. Normally internal procedures within an office or department are not included in the SPG.

Standard Treatment

A treatment currently in widespread use and/or approved by the FDA, considered to be effective in the treatment of a specific disease or condition.

Statistical Significance

The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.

Sterility

• The absence of viable contaminating microorganisms; aseptic state.
• The inability to procreate; the inability to conceive or induce conception.

Stipend

A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training. A stipend is not considered compensation for the services expected of an employee.

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 Coordinator

Person appointed at the institute/center where the study is being conducted.

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.

Study Type

The primary investigative techniques used in an observational protocol; types are Purpose, Duration, Selection, and Timing.

Sub-Contract, Sub-Award, Sub-Grant, or Sub-Agreement

A document written under the authority of, and consistent with the terms and conditions of an award (a grant, contract or cooperative agreement), that transfers a portion of the research or substantive effort of the prime award to another institution or organization.

Sub-Investigator (Sub-I)

A member of the study team other than the investigator—e.g., study coordinator, resident, fellow, attending staff member, other physician, or additional personnel—with close knowledge of a study. See also 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.

Subs

Short for subcontractors.

Summary Document

A written version of the full information presented to a participant or the participant's legally authorized representative during the informed consent process, used in conjunction with a short form consent document. For non-English speaking individuals, the IRB-approved English language consent form may serve as the summary when an appropriately translated document is not available.

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.