Glossary of Clinical Research - S

S

• Safety & tolerability

The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and haematology), vital signs, clinical adverse events (diseases, signs and symptoms), and other special safety tests (e.g. ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject. (ICH E9)

• Screening trials

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

• Selection bias

An error in choosing the individuals or groups to take part in a study. Ideally, the subjects in a study should be very similar to one another and to the larger population from which they are drawn (for example, all individuals with the same disease or condition). If there are important differences, the results of the study may not be valid. (NCI)

• Serious Adverse Event

Any untoward medical occurrence that at any dose: 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. (ICH E6)

• Sham therapy

An inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial. Also called placebo therapy. (NCI)

• Side effect

• A problem that occurs when treatment affects healthy tissues or organs. (NCI)
• Any undesired actions or effects of a drug or treatment. Negative or adverse effects 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 (NLM)

• Significant

In statistics, describes a mathematical measure of difference between groups. The difference is said to be significant if it is greater than what might be expected to happen by chance alone. Also called statistically significant. (NCI)

• Single blind study

• A type of clinical trial in which only the doctor knows whether a patient is taking the standard treatment or the new treatment being tested. This helps prevent bias in treatment studies. (NCI)
• 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. (NLM)

• Source Data

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)

• Source Documents

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)

• Sponsor

• An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. (ICH E6)
• A person who initiates a clinical investigation, but who 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 an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators. (21CFR50.3)

• Sponsor-Investigator

• 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)
• 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., corporation or agency. (21CFR50.3)

• Standard treatment

A treatment currently in wide use and approved by the FDA, considered to be effective in the treatment of a specific disease or condition. (NLM)

• Standards of care

Treatment regimen or medical management based on state of the art participant care. (NLM)

• Standard Operating Procedures

Detailed, written instructions to achieve uniformity of the performance of a specific function. (ICH E6)

• Statistical analysis plan

A statistical analysis plan is a document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. (ICH E9)

• 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. (NLM)

• Study endpoint

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

• Study type

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

• Subinvestigator

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). (ICH E6)

• Subject Identification Code

A unique identifier assigned by the investigator 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. (ICH E6)

• Subject/Trial Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. (ICH E6)

• Superiority trial

A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). (ICH E9)

• Surrogate variable

A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical. (ICH E9)