ACORI | Dictionary: $S

Safety Monitoring Plan

The safety monitoring plan identifies, monitors, and documents activities related to the progress of clinical studies, the responsibility of committees and members, the safety of the participants, the validity and integrity of the data, and the appropriate time to terminate studies when significant benefits or risks have been uncovered.

Safety Officer

A safety officer is an independent individual, often a clinician who is appointed by the National Institutes of Aging (NIA), who performs data and safety monitoring activities in low-risk, single site clinical studies. The Safety Officer advises the NIA regarding participant safety, scientific integrity, and ethical conduct of a study. (NIH)

Sample Size

A sample size is a subset of a larger population that clinical studies examine in order to make conclusions or estimates about the larger population.

Schedule of Activities

A schedule of activities is a standardized representation of planned clinical study activities including interventions (e.g., administering medicines, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical study material and diaries, randomization) as well as assessments. (CDISC)

Schedule of Assessments

A schedule of assessments is a tabular representation of the planned clinical study events and activities, in sequence. (CDISC)

Schema

A schema is the general design of clinical study regarding the strategy for assigning interventions to participants or groups of participants and the analysis of data.

Screening Log

A screening log records all individuals who entered the screening process for a clinical study. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants. (NIH)

Screening of Subjects

Screening of subjects is when clinical study investigators evaluate potential participants for a given clinical study.

Screening Process

The screening process is designed to determine an individual’s eligibility for participation in a clinical study. (NIH)

Screening Studies

Screening studies evaluate new tests for detecting diseases (i.e., cancer) or other health conditions in people before symptoms are present.

Secondary Objective

Secondary objectives are research objectives that are secondary to the primary goal of a clinical study. Often these secondary objectives provide further information on the use of the treatment being studied.

Secondary Outcome Measure

In a clinical study's protocol, a secondary outcome measure is a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure. (CTG)

Secondary Outcome Variable

In a clinical study's protocol, a secondary outcome variable is a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome variable. (CTG)

Serial Biopsies

Serial biopsies are a set of tissue samples taken at different times during the course of therapy. A series of biopsies provides insight on whether a treatment is working and how the cancer changes in response to the therapy. Often, this is some of the most valuable data collected during a clinical study. (SUTC)

Serious Adverse Drug Reaction

Serious adverse drug reactions can happen at any dose of a medicine and can result in: inpatient hospitalization or prolonged existing hospitalization; persistent or significant disability, incapacity, congenital anomalies, or birth defects; or death.

Serious Adverse Event (SAE)

Serious adverse events are any event that: results in death; is life threatening or place the clinical study participant at immediate risk of death from the event as it occurred; requires or prolongs hospitalization; causes persistent or significant disability or incapacity; results in congenital anomalies or birth defects; or creates another condition which investigators judge to represent significant hazards. (NIH)

Serious Adverse Experience

A serious adverse experience is any experience that suggests a significant hazard, side effect, or precaution. (CDISC)

Serious Risk

Serious risk in a clinical trial that indicates the potential for a serious adverse event.

Sex

Sex is a type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility. (CTG)

Sham Comparator Arm

A sham comparator arm is a group of clinical study participants that receives a treatment, procedure, or device that appears to be the same as the actual treatment, but has no real effect on the disease or condition being studied.

Sham Comparator Branch

A sham comparator branch is a group of clinical study participants that receives a treatment, procedure, or device that appears to be the same as the actual treatment, but has no real effect on the disease or condition being studied.

Sham Comparator Group

A sham comparator group is a collection of clinical study participants that receives a treatment, procedure, or device that appears to be the same as the actual treatment, but has no real effect on the disease or condition being studied.

Shared Decision Making

Shared decision making is a key component of patient- centered health care. It is a process in which clinicians and patients work together to make decisions and select tests, treatments, and care plans based on clinical evidence that balances risks and expected outcomes with patient preferences and values.

Side Effects

Side effects are any actions or effects of a medicine or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental medicines must be evaluated for both immediate and long-term side effects. (CDISC)

Single-blinded Study

In a single-blinded clinical study, only the investigator (not the participant) knows which medication or placebo was administered. (CDISC)

Single-entity Product

A single-entity product is composed of two or more medical treatment elements that are physically, chemically, or otherwise combined or mixed and produced as a single entity.

Single-group Assignment

Single-group assignment is a type of clinical study in which all participants receive the same intervention/treatment.

Single-masked Study

In a single-masked clinical study, only the investigator (not the participant) knows which medication or placebo was administered. (CDISC)

Site Investigator

A site investigator is a person responsible for the conduct of the clinical study at a study site. If a study is conducted by a team of individuals at a study site, the investigator is the responsible leader of the team and may be called the principal investigator. (CDISC)

Socioeconomic Status (SES)

Socioeconomic status measures a person's economic and social standing based on their work experience and economic and social position. SES is typically divided into three levels — high, middle, and lower — based on any or all of the three variables (income, education, and occupation).

Source Data

Source data is all information (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, study participant diaries, recorded data from automated instruments, x-rays, etc.) pertaining to the clinical findings, observations, or other activities from a clinical study. They are located in original records and certified copies of original records (source documents) that can be used to reconstruct and evaluate a study. (CDISC)

Source Documents

Source documents are original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, study participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a clinical study. (NIH)

Special Population

A special population is a subset of a clinical study population that is of particular interest in the study. It is included to ensure that the specific characteristics of this population are considered when investigators interpret the data from the clinical study. (e.g., geriatric). (CDISC)

Sponsor

A sponsor is the organization or person who initiates the clinical study and who has authority and control over the clinical study. (CTG)

Sponsor-Investigator

A sponsor-investigator is an individual who both initiates and conducts (alone or with others) a clinical study and under whose immediate direction the investigational product is administered to participants. NOTE: The term does not include any person other than an individual (i.e., 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. (CDISC)

Standard of Care

Standard of care is the treatment currently in wide use and approved by Food and Drug Administration or other health authority and considered to be effective in the treatment of a specific disease or condition. (CDISC)

Standard Operating Procedures

Standard operating procedures are detailed written instructions that ensure uniformity in the performance of specific functions across studies and participants at an individual site. (NIH)

Standard Treatment

Standard treatment is the treatment currently in wide use and approved by Food and Drug Administration or other health authority and considered to be effective in the treatment of a specific disease or condition. (CDISC)

Statistical Analysis Plan

A statistical analysis plan is the written description of the statistical considerations and methods for analyzing the data collected in the clinical study. (CTG)

Statistical Significance

If clinical study results have high statistical significance it means that the effect the study is evaluating (e.g., reduction in disease) is likely attributable to the medicine or treatment being administered and examined.

Stopping Rules

Stopping rules are a set of criteria that help investigators determine when a clinical study should be stopped early. Reasons for stopping a study include: potential patient harm or that the treatment effect that is so great, further data collection is unnecessary.

Stratification

Stratification is the separation of a clinical study cohort into subgroups or strata according to specific characteristics, such as age, gender, etc., so that factors which might affect the outcome of the clinical study, can be taken into account. (NIH)

Study

Study in this context refers to clinical trial or observational study. A clinical trial (or interventional clinical study) tests or evaluates an intervention — medicine, medical device, activity, or procedure — in people. In an observational study, researchers observe participants on their current treatment plan and track health outcomes.

Study Completion

Study completion is the point at which all protocol-required activities in the clinical study design have been executed.

Study Completion Date

The study completion date is when investigators have treated or examined the last participant in a clinical study and collected all information needed for the primary outcome measures, secondary outcome measures, and adverse events.

Study Design

The study design is the investigative methods and strategies used in the clinical study. (CTG)

Study IDs

Study IDs are identifiers that are assigned to a clinical study by the sponsor, funders, or others. They include unique identifiers from other study registries and National Institutes of Health grant numbers.

Study Initiation Date

The study initiation date when the first participant enrolled in a clinical study.

Study Participant

A study participant is a person who has enrolled in and is participating in a clinical study.

Study Population

A study population is a group of individuals taken from the general population who share a set of common characteristics (e.g., age, sex, health condition) precisely defined in the clinical study protocol. This is a population to which the clinical study results could be reasonably applied. (CDISC)

Study Record

The study record is an entry on ClinicalTrials.gov that contains a summary of a clinical study's protocol information, including the recruitment status; eligibility criteria; contact information; and, in some cases, summary results. Each clinical study record is assigned a ClinicalTrials.gov identifier, or NCT number. (CTG)

Study Registry

The study registry is a structured online system, such as ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies. (CTG)

Study Site

The study site is the location at which clinical study activities are conducted.

Study Type

The study type describes the nature of a clinical study. The main cancer study types include interventional clinical studies (also called clinical trials) and observational studies.

Study-related Injury

Study-related injuries are injuries or complications in a clinical study that happen as a result of participants using the investigational medicine or device and/or from any other aspect of the study performed in accordance to the study protocol.

Subject

A subject is a person who has signed up for and is engaged in a clinical study, also referred to as a participant.

Subject Completion

Subject completion is when a clinical study participant ceases to be actively engaging in a clinical study because the participant has, or is presumed to have followed all appropriate conditions of a protocol. (CDISC)

Subject Data Event

A subject data event is a visit or other encounter with a clinical study participant where data are collected, generated, or reviewed. (CDISC)

Subject Identification Code

A subject identifier code is a unique identifier assigned by the investigator to each clinical study subject to protect the subject's identity. It is used instead of the subject's name when the investigator reports adverse events and/or other clinical study-related data. (CDISC)

Subject Monitoring

Subject monitoring is the act of tracking, reporting, and reviewing a clinical study subject's status and/or performance of required activities per protocol. (CDISC)

Subject Number

A subject number is a unique number assigned to each participant who enrolls into a clinical study. (NOV)

Subject Wellbeing

Subject wellbeing refers to the physical and mental integrity of the participants in a clinical study. (CDISC)

Subject-reported Outcome

A subject-reported outcome is any type of clinical outcome assessment where the clinical study participant directly reports his or her health condition in some form of questionnaire. These assessments are free from amendment or interpretation by a clinician or anyone else. These questionnaires might assess things like: pain level, quality of life, ability to perform daily tasks, mobility, etc.

Submitted Date

The submitted date is when the clinical study sponsor or investigator submitted a clinical study record that is consistent with National Library of Medicine quality control review criteria. (CTG)

Superiority Trial

The primary objective of a superiority trial is to demonstrate that the response to the treatment being tested is superior to another treatment. Whether or not that other treatment contains active or inactive ingredients.

Supportive Care Trials

Supportive care trials evaluate treatments and interventions to improve the comfort and quality of life of people with a chronic illness such as cancer (i.e., reducing side effects of a treatment).

Surrogate Endpoint

Surrogate endpoints are used in clinical studies as a substitute for a direct measure of how a participant feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. (CDISC)

Surrogate Marker

A surrogate marker is a measurement of a medicine's biological activity that investigators use as a substitute for a clinical endpoint, such as death or pain relief. (CDISC)

Surrogate Variable

A surrogate variable provides an indirect measurement of an effect in situations where the direct measurement of a clinical effect is not feasible or practical. (CDISC)

Survey

A survey is any means (e.g., questionnaire, diary, interview, etc.) that is used to collect personally-reported data.

Suspension

Suspension is when a clinical study has been stopped but might start again.

Clinical Research Terms Glossary

Terms starting with S