Clinical Research Dictionary

Clinical Research Dictionary

(Glossary of Terms and Acronyms)

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Safety		Relative freedom from harm
Safety (in relation to trials)		1.) This refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects. 2.) Analysis of the risks associated with an investigational drug. Safety is measured by collecting information from adverse event reports and pharmacokinetic studies.
Safety Assessment		See Risk-Benefit Ratio
Safety Report (in terms of FDA)		See Med Watch Form
Sample Size		1.) The number of subjects required to meet the trial's scientific objectives. 2.) The size of the sample to be used for the performance of a specified test.
Satellite Site		An investigational site (clinic, hospital, physician's office, etc.) separate in geographic location from, but under the direct control of, the principal investigator.
Scheduled Continuation Review (in relation to IRBs)		See Interim Report (in relation to IRBs)
Scheduled Continuing Review (in relation to IRBs)	SCR	See Interim Report (in relation to IRBs)
Science, Technology and Economic Policy Board	STEP	Is to integrate understanding of scientific, technological, and economic elements in the formulation of national policies affecting the economic well-being of the United States. Policymakers responsible for trade, economic, science, and technology policy in the Executive Branch and Congress are the principal audience for the Board's work.	http://www7.nationalacademies .org/step/
Scientific Misconduct		See Misconduct (in terms of Research)
Scientific Review Group (in terms of NIH)		A group of highly regarded experts in a given field, convened by National Institutes of Health (NIH) to advise NIH on the scientific merit of applications for research grants and contracts.
Screening		The process of evaluting potential clinical trial subjects to determine if they meet protocol inclusion / exclusion criteria before enrollment.
Screening Methods		Clinical examiniations and tests used by investigators to determine whether potential study subjects meet the entry criteria for a specific study.
Screening Trial		Clinical trials that address new methods for detecting disease
Script		A program or a sequence of instructions that are interpreted or carried out by another program.
Search Engine		An online service that compares your search criteria with its database of information about the Internet and displays the results.
Secondary Endpoints		Supportive measurements related to the primary objective. Also refers to measurements of effects related to secondary objectives.
Secretary (in terms of DHHS)		Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.	45 CFR 46.202(g)
Sequential Design		See Group Sequential Design
Serious Adverse Drug Experience / Event		Any adverse drug experience occurring at any dose that results in any of the following outcomes: 1.) Death. 2.) A life-threatening adverse drug experience. 3.) Inpatient hospitalization or prolongation of existing hospitalization. 4.) A persistent or significant disability / incapacity. A congenital anomaly/birth defect. 5.) Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.	21 CFR 312.32
Serious Adverse Drug Reaction (in relation to ICH)	SADR	See Serious Adverse Event (in relation to ICH)	ICH E6 1.50
Serious Adverse Drug Reaction (in relation to IRBMED)	SADR	See Serious Adverse Event (in relation to IRBMED)
Serious Adverse Event / Experience (in relation to ICH)	SAE	Any untoward medical occurrence that at any dose: 1.) Results in death. 2.) Is life-threatening. 3.) Requires inpatient hospitalization or prolongation of existing hospitalization. 4.) Results in persistent or significant disability/incapacity. 5.) Is a congenital anomaly/birth defect. See also Serious Adverse Drug Experience	ICH E6 1.50
Serious Adverse Event / Experience (in relation to IRBMED)	SAE	(1) Any untoward occurrence that: a.) Results in death. b.) Is life-threatening. c.) Requires inpatient hospitalization or prolongation of existing hospitalization. d.) Results in persistent or significant disability/incapacity. e.) Is a congenital anomaly/birth defect (ICH Guidelines). (2) 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.
Server		A computer program that provides services to other computer programs in the same or other computers. See also Web server.
Seven-Day Telephone Report		(US) A type of expedited AE reporting. For a study conducted under a US IND, a telephone report made to the DA by the sponsor within seven calendar days of learning of an unexpected, fatal or life-threatening event associated with the use of the drug.
Seven Days (in relation to IRBMED)		The IRBMED office should receive reports within seven business days of the event or investigator's receipt of notification of the event. (Because the reporting of adverse events can be a time-sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to adverse event notifications and reports from subjects, sponsors and other sources.)
Severe-Serious Distinction (in relation to IRBMED)		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 adverse event" 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.
Severe Adverse Event (in relation to IRBMED)		An event which causes significant discomfort and requires treatment, and which poses a significant or permanent risk of harm to the subject or requires in-patient hospitalization or prolongation of hospitalization. A severe adverse event is considered Grade III using CTC (Common Toxicity Criteria).
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).
Sexually Transmitted Disease	STD	Any of various diseases usually transmitted by direct sexual contact that include the classic venereal diseases (as syphilis, gonorrhea, and chancroid) and other diseases (as hepatitis A, hepatitis B, giardiasis, and AIDS) often or sometimes contracted by other than sexual means
Sherley Amendment of 1912		(US) A law prohibiting the labeling of drugs with fraudulent therapeutic claims intended to defraud the purchaser.
Shipping Records (in relation to Investigational Product)		Document for shipment dates, batch numbers and method of shipment of investigational product(s) and for tracking product batch, review of shipping conditions, and accountability	ICH E6 8.2.15
Side Effect		1. (US) Lay terminology for adverse reaction to a drug. The connotation is that a side effect is generally related to drug use (mild, expected, and tolerated by the patient). 2. (ICH) The ICH Draft Guidelines for Clinical Safety Management recommend that the term "side effect" no longer be used and particularly should not be regarded as a synonymous with an adverse event or adverse reaction. See also Adverse Event (in relation to ICH)
Signatory Official (in terms of OHRP)		Senior institutional official who has the authority to commit the entire institution named in the Federal Wide Assurance (FWA) application
Signature Authorization Form	SAF	See Delegation of Authority Log
Signature Sheet		Document with signatures and/or initials of all persons authorized to make entries and/or corrections on CRFs	ICH E6 8.3.24
Significant (in relation to Biostatistics)		See Statistically Significant
Significant Equity Interest in the Sponsor of a Covered Study		Any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (generally, interests in a nonpublicly traded corporation), or any equity interest in a publicly traded corporation that exceeds $50,000 during the time the clinical investigator is carrying out the study and for 1 year following completion of the study.	21 CFR 54.3
Significant Payments of Other Sorts	SPOOS	Payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator that have a monetary value of more than $25,000, exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following the completion of the study.	21 CFR 54.3
Significant Risk Device		An investigational device that: 1.) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; 2.) is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject; 3.) is 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 4.) otherwise presents a potential for serious risk to a subject.	21 CFR 812.3
Signs		Physical abnormalities noted by the investigator and/or staff on examination of the subject.
Single Blind		1.) Only the subject(s) does not know which treatment they are receiving in a clinical trial. 2.) A design of a study where the investigator knows which medication the subject is given, but the subject does not.
Single Center Study		A trial that is only being conducted at one study center
Single Masked		See Single Blind
Single Project Assurance	SPA	A document approved by OHRP from a prospective awardee or other institutional performance site to be engaged in Department of Health and Human Services conducted or supported research that assures institutional compliance with and implementation of regulations (i.e., 45 CFR Part 46) for the protection of human subjects. It is limited in use and duration to an individual research activity and will be replaced by a Federal Wide Assurance.
Single Source Drug		A drug marketed by only one company.
Site		A place where a clinical trial is conducted, typically, where the investigator and study coordinator are located
Site Assessment		A review of the facilities and capabilities of a site and staff to undertake a clinical trial.
Site Assessment Visit Report		See Pre-Trial Monitoring Report
Site Audit		An audit actually conducted at a clinical trial-related site (e.g., investigator, Institutional Review Boards, laboratory)
Site Delegation Log		See Signature Authorization Form
Site Initiation		A site visit conducted by a monitor following agreement by the investigator to participate in the trial.
Site Management Organization	SMO	A team of investigators and clinical research personnel that offers their clinical research services to sponsors (e.g., pharmaceutical companies) of trials
Site Qualification		The process by which a potential investigational site is found to be competent to perform a clinical trial.
Site Qualification Visit Report		See Pre-Trial Monitoring Report
Site Visit		Any visit made by a representative from the company / sponsor during the implementation, active, and termination stages of a trial. May also only refer to monitoring visits.
Site Visit (in relation to OHRP or FDA)		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.
Site Visit Log		1.) A log that is kept at the investigator's site and is signed and dated by any sponsor staff member who visits the site. 2.) A form used to document sponsor visits to a study site. This log generally includes the date of the visit, the type of visit, and the monitor's / sponsor's representative's signature.
Skeleton Tables / Figures		Sample outlines that demonstrate the format and content to be included in the statistical report or integrated clinical statistical summary.
Skilled Care		A type of health care given when you need skilled nursing or rehabilitation staff to manage, observe, and evaluate your care.
Skilled Nursing Care		A level of care that includes services that can only be performed safely and correctly by a licensed nurse (either a registered nurse or a licensed practical nurse).
Skilled Nursing Facility	SNF	A facility (which meets specific regulatory certification requirements) which primarily provides inpatient skilled nursing care and related services to patients who require medical, nursing, or rehabilitative services but does not provide the level of care or treatment available in a hospital.
Skilled Nursing Facility Care		This is a level of care that requires the daily involvement of skilled nursing or rehabilitation staff. Examples of skilled nursing facility care include intravenous injections and physical therapy.
Small Business Administration	SBA	Maintain and strengthen the nation's economy by aiding, counseling, assisting and protecting the interests of small businesses and by helping families and businesses recover from national disasters.	http://www.sba.gov/
Small Business Innovative Research	SBIR	SBIR is a highly competitive program that encourages small business to explore their technological potential and provides the incentive to profit from its commercialization. By including qualified small businesses in the nation's R&D arena, high-tech innovation is stimulated and the United States gains entrepreneurial spirit as it meets its specific research and development needs.
Small Business Technology Transfer	STTR	STTR is an important new small business program that expands funding opportunities in the federal innovation research and development arena. Central to the program is expansion of the public/private sector partnership to include the joint venture opportunities for small business and the nation's premier nonprofit research institutions. STTR's most important role is to foster the innovation necessary to meet the nation's scientific and technological challenges in the 21st century.
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 Act		Public Law 74-271, enacted on August 14, 1935, with subsequent amendments. The Social Security Act consists of 20 titles, four of which have been repealed. The HI and SMI programs are authorized by Title XVIII of the Social Security Act.
Social Security Administration		The Federal agency that, among other things, determines initial entitlement to and eligibility for Medicare benefits.
Society for Clinical Trials	SCT	The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct and analysis of government and industry-sponsored clinical trials and related health care research methodologies.	http://www.sctweb.org/
Society of Clinical Research Associates	SOCRA	A non-profit, professional organization dedicated to the continuing education and development of clinical research professionals	http://www.socra.org/
Society of Quality Assurance	SQA	The SQA is a professional membership organization dedicated to providing a forum for information exchange and utilization of knowledge in research and regulatory quality assurance, promoting the profession through leadership and effective professional relationships, enhancing knowledge of regulatory and quality assurance concerns that impact research, and fostering the highest professional standards leading to growth, development and recognition of the quality assurance profession worldwide.	http://www.sqa.org/
Society of Research Administrators	SRA	The SRA International is a nonprofit association dedicated to the education and the professional development of research administrators, as well as the enhancement of public understanding of the importance of research and its administration. The Society shall fulfill its mission by means of the following purposes: The education of research administrators, professionals in related fields, and the public through the exchange of information, individual contacts, professional presentations, formal and informal meetings and publications and the improvement of communications among researchers, host institutions and organizations, the sponsors of research administrators, and the general public.	http://www.srainternational.org/newweb /default.cfm
Source Data		ICH Definition: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).	ICH E6 1.51
Source Data / Document Verification	SDV	The verification of the authenticity of the information presented in the CRF and, where needed, the possibility of completing or correcting it, provided that the conditions regulating the use and consultation with source documents are respected (i.e., confidentiality).	EU GCPs
Source Documents		ICH Definition: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial).	ICH E6 1.52
Southwest Oncology Group	SWOG	(US) The Southwest Oncology Group is an adult cancer clinical trials organization, one of the largest in the world. Our National Cancer Institute-sponsored Cooperative Group's membership and network consists of almost 4,000 of the nation's leading physicians at 283 institutions throughout the United States and Canada.	http://www.swog.org/
Special Packaging (in relation to Drug)		Packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.	21 CFR 310.3 (l)
Special Reports		(US) FDA regulations state that sponsors must be prepared to file a number of special types of reports, at any time upon the agency's request (e.g., advertising and promotional labeling, etc.).
Specialist		A doctor who treats only certain parts of the body, certain health problems, or certain age groups. For example, some doctors treat only heart problems.
Specimen Tubes		Containers for biological samples, such as blood and urine.
Speech-Language Therapy		Treatment to regain and strengthen speech skills.
Spell of Illness		A period of consecutive days, beginning with the first day on which a beneficiary is furnished inpatient hospital or extended care services, and ending with the close of the first period of 60 consecutive days thereafter in which the beneficiary is in neither a hospital nor a skilled nursing facility.
Sponsor		ICH Definition: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial, but who does not actually conduct the investigation.	ICH E6 1.53
Sponsor-Investigator		ICH Definition: An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.	ICH E6 1.54
Sponsor of the Covered Clinical Study		The party supporting a particular study at the time it was carried out.	21 CFR 54.3
SPIN		On-line search system for research opportunities developed by the University of New York System	http://www.research.umich.edu /funding/funding.html
Staff Signature Log		See Signature Sheet
Standard Deviation	SD	The statistical indicator of the relative variability with a group; the square root of the variance.
Standard Error (statistics)	SE	The standard deviations of the sample in a frequency distribution, obtained by dividing the standard deviation by the total number of cases in the frequency distribution.
Standard New Drug Application		An application with the performance goal for FDA review of 10-12 months for a product that is not designated as a Priority NDA.
Standard Operating Procedures	SOPs	Official, detailed, written instructions for the management of clinical trials. SOPs ensure that all the functions and activities of a clinical trial are carried out in a consistent and efficient manner.	ICH E6 1.55
Standard treatment or care		The currently accepted treatment for a medical condition. Potential new treatments are compared against the standard treatment in clinical trials.
Statement of Investigator (Form FDA-1572)	SOI	1.) Official legal FDA document that outlines the obligations of investigator signed and dated by the investigator before initiating a Phase 1-3 study in the United States that is formally filed to an Investigational New Drug Application 2.) (US) The FDA form that must be completed and signed by the investigator to indicate his/her agreement to abide by US federal regulations and the study protocol durign the course of a clinical trial conducted under an IND.
State Law		A constitution, statute, regulation, rule, common law, or other State action having the force and effect of law.
Statement of Work	SOW	Each contract document contains a statement of work or a description of the services to be provided. This work statement should be drafted with great care. Failure by the University / contractor to deliver the results anticipated or to perform the work defined in the statement of work is a breach of contract.
Statistical Analysis (in relation to clinical trials)		The mathematical evaluation of clinical trial data using methods and techniques written in the protocol
Statistical Analysis Plan		1.) A formal document prepared by a Biostatistics department that contains more technical detail of the principal features of the analyses described in the protocol. 2.) A highly specific plan written by statisticians containing detailed descriptions of all statistical methods to be used in the analysis of study data, including all data listing tables and graphs pertaining to data anaylses as described in the clinical protocol. Planned interim analyses and a description of subject populations are also included.
Statistical Analysis Software	SAS	A name brand of a specific software system for data analysis and report writing.
Statistical Interaction		A phenomenon that may occur as the result of cross classifying two or more levels of two factors or effects.
Statistical Report		An anaylsis of the data collected from a study or group of studies within a protocol or across multiple protocols within a project. The statistical report is prepared by statisticians at the end of a trial.
Statistical Significance		A determination of the probability of obtaining the particular distribution of the data on the assumption that the null hypothesis is true. Or, more simply put, the probability of coming to a false positive conclusion. [See McLarty (1987), p. 2.] If the probability is less than or equal to a predetermined value (e.g., 0.05 or 0.01), then the null hypothesis is rejected at that significance level (0.05 or 0.01).
Statistically Significant		A term indicating that the results of a study are stronger than would be expected from chance alone
Statistical Methods		The mathematical tests and techniques that are to be used to evaluate clinical trial data.
Statistician		An expert in mathematics and statistics. Statisticians (or biostatisticians -- experts in the statistics of biological and human studies) analyze the results of clinical trials to decide whether differences between the intervention groups are significant or merely the result of chance.
Statistics (in relation to clinical trials)		See Biostatistics
Sterility		1.) The absence of viable contaminating microorganisms; aseptic state. 2.) The inability to procreate; the inability to conceive or induce conception.
Stochastic		Involving a random variable; involving chance or probability.
Stochastic Model		An analysis involving a random variable. For example, a stochastic model may include a frequency distribution for one assumption. From the frequency distribution, possible outcomes for the assumption are selected randomly for use in an illustration.
Stopping Rules		Rigorous guideline criteria specified in advance of the start of the study in the protocol, outlining what interim evidence of a therapy's inferiority or superiority may merit stopping the trial.
Stratification		1.) The placing of the trial population into categories (i.e., strata) which are: a.) exhaustive (i.e., all strata together include the entire trial population); b.) mutually exclusive and; c.) related to the criteria being studied and with each category subjects should be similar with respect to this criteria. 2.) Assignment of subjects to groups based on some relevant factor (e.g., sex, age, prognostic factors) in such a way that there are equal proportions in the test groups within treatment groups.
Stratified Analysis		Significance testing performed on subgroups of similar subjects within treatment groups.
Stratified Randomization		A process of distributing subjects into study groups, typically used in small studies, where simple randomization may produce uneven treatment groups with respect to a relevant subject characteristic.
Study Arm		One part, segment or specific treatment group of a trial
Study Close-Out Visit		The final visit to a site after the study has been completed or terminated. Also called termination visit.
Study Close-Out Visit Report		See Final Trial Close-Out Monitoring Report
Study Coordinator	SC	See Clinical Research Coordinator	EU GCPs
Study Design		An outline of the plan for answering the question(s) posed by the study. The most commonly used designs are "parallel", "crossover", "forced titration", and "optional titration".
Study Drug		See Investigational Drug
Study Initiation Visit		An on-site meeting conducted by a representative of the sponsor to ensure that the investigator and study staff are ready to start enrolling subjects. This is done when all company-related paperwork is in-house, the study has received IRB approval, and the investigator has received the clinical supplies. Generally, no subject should be enrolled until this visit has been made. Also called "study placement visit".
Study Initiation Visit Report		See Trial Initiation Monitoring Report
Study Leader		A individual, generally employed with the sponsor company, who is responsible for the overall management of a clinical trial. This individual may be a lead CRA, a medical monitor, or clinical manager.
Study Manual		A compilation of essential information for monitors and site staff. It generally contains the clinical protocol, names of study personnel, location of study sites, information about the investigational drug, the handling of adverse events, regulatory considerations, and specific instructions for the completion of CRFs. See also Monitor Manual
Study Materials		See Clinical Trial Materials
Study Medication		Any medication, including placebo, specific in, and dispensed under, a clinical protocol.
Study Monitor		See Monitor
Study Number		Unique alpha and/or numeric identifier assigned to each clinical trial
Study Nurse		See Research Nurse
Study Section (in terms of NIH)		See Scientific Review Group
Study Site		The primary place where the investigator sees the subjects enrolled in a clinical study. A study site may be a hospital, clinic, or physician's office.
Study Staff		The individuals employed at a study site and responsible for all procedures, medication, and documentation involved in a clinical trial. The study staff includes the investigator, sub-investigators, study coordinators, nurses, pharmacists, and support staff. Also called "site staff".
Study Start-Up Visit Report		See Trial Initiation Monitoring Report
Study Subject		See Subject
Study Supplies		Non-drug supplies (e.g., specimen containers, forms) needed by study staff to conduct the study. See also Clinical Trial Materials
Study Treatment		See Treatment
Sub-account		A formally designated project account, which is subsidiary to a larger project within the University.
Sub-contract		A formally designated project in which the direct sponsor receives funds from a prime sponsor; or an arrangement in which the University provides funds for performing a part of a project to another organization.
Sub-Investigator		1.) Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). 2.) Individuals (research fellows, residents, associates) who assist the principal investigator (PI) in the conduct of the clinical trial. A sub-investigator has authority delegated to him/her by the PI, but does not have responsibility for the overall conduct of the trial.	ICH E6 1.56
Subject		An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.	ICH E6 1.57
Subject Enrollment Log		Document for the chronological enrollment of subjects by trial number	ICH E6 8.3.22
Subject Identification Code		A unique identifier assigned by the investigator or sponsor to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data. Also called "subject study number".	ICH E6 1.58
Subject Identification Code List		Document such that investigator/institution keeps a confidential list of names of all subjects allocated trial numbers on enrolling in the trial and allows investigator/institution to reveal identity of any subject	ICH E6 8.3.21
Subject Informaton Display		A printout of all the subject information recorded on the database for a particular clinical study.
Subject Number		See Patient Number
Subject Recruitment		See Recruitment (in relation to subjects)
Subject Screening Log		Document for identification of subjects who entered pre-trial screening	ICH E6 8.3.20
Subsidized Senior Housing		A type of program, available through the Federal Department of Housing and Urban Development and some States, to help people with low or moderate incomes pay for housing.
Substance Abuse and Mental Health Services Administration	SAMHSA	Includes the Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center on Mental Health Services. Previously the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). See also ADAMHA.
Summary Basis of Approval	SBA	Document issued by Food and Drug Administration (FDA) which outlines the key data and results which supported the decision to approve the marketing application (e.g., New Drug Application)
Summary Basis of Approval Document	SBA	(US) A document containing the FDA's explanation of the rationale approving a specific drug. The SBA is designed to provide important insights into a drug, its study and its effects.
Summary Format		Tabulations, charts, or other analyzed system used to report to the IRBMED all Adverse Events occurring during a study (regardless of relatedness or severity) noted in the Timetables as reportable with the Scheduled Continuation Application. Frequency, expectedness, etc. of number of events in relation to number of subjects enrolled, locally and at all sites, should be readily discernible to the IRBMED.
Supplemental New Drug Application	sNDA	(US) Documentation submitted to the Food and Drug Administration on a drug product which is already the subject of an approved NDA for a variety of reasons (e.g., labeling change, new or expanded clinical indication, new dosage form)
Supportive Data		Additional safety and efficacy information on a product generated in studies that do not meet FDA standards for "well-controlled" studies necessary for drug approval.
Surrogate		A family member or close friend authorized by these regulations to make human subject research decisions for n adults without capacity to consent to research participation in the absence of a health care agent and a research agent. The surrogate for an adult without capacity to consent to research participation would be one person from the following list, chosen from the class highest in priority when persons in prior class are not reasonably available, willing, and competent to act: 1.) The spouse, if not legally separated from the adult; 2). A son or daughter eighteen years or older; 3.) A parent; 4.) A brother or sister eighteen years or older; 5.) A close friend or relative eighteen years or older.
Surrogate Endpoints		Generally, an event or measure that is thought to be related to, and to be likely to predict, the drug's effect on more clinically relevant, or primary endpoints.
Surrogate Marker		A measurement of a product's biological activity that substitutes for a clinical trial endpoint, such as death or pain relief.
Surveillance, Epidemiology, and End Results	SEER	The Surveillance, Epidemiology, and End Results (SEER) Program of the NCI is an authoritative source of information on cancer incidence and survival in the United States.	http://seer.cancer.gov/
Survey		An investigation in which information is systematically collected
Symptom		A physical or mental disturbance or abnormality felt by the subject
Syntax		The rules and conventions that one needs to know or follow in order to validly record information, or interpret previously recorded information, for a specific purpose. Thus, a syntax is a grammar. Such rules and conventions may be either explicit or implicit. In X12 transactions, the data-element separators, the sub-element separators, the segment terminators, the segment identifiers, the loops, the loop identifiers (when present), the repetition factors, etc., are all aspects of the X12 syntax. When explicit, such syntactical elements tend to be the structural, or format-related, data elements that are not required when a direct data entry architecture is used. Ultimately, though, there is not a perfectly clear division between the syntactical elements and the business data content.
Systematized Nomenclature of Medicine Clinical Terms	SNOMED CT	SNOMED CT®, is the universal health care terminology that makes health care knowledge usable and accessible wherever and whenever it is needed. This strong foundation is leading the health care industry in building a seamless infrastructure of worldwide care while integrating an overwhelming amount of clinical data. The SNOMED CT Core terminology provides a common language that enables a consistent way of capturing, sharing and aggregating health data across specialties and sites of care. Among the applications for SNOMED CT are electronic medical records, ICU monitoring, clinical decision support, medical research studies, clinical trials, computerized physician order entry, disease surveillance, image indexing and consumer health information services.	http://www.snomed.org/
Systems Audit		A type of audit performed for regulatory compliance to evaluate general processes used in the conduct of clinical trials
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