Glossary S through Z
Safety Monitor – Person responsible for the review and evaluation of information relevant to the safety of the drug (listed on Line 15 of the Form FDA 1571).
Safety Physician/Medical Monitor – A physician designated to be responsible for monitoring medical safety of the subjects in a given study, including, but not limited to, unblinding, AE reporting, and management.
Senior Statistical Reviewer – A senior statistician who performs experimental statistical review to ensure scientific integrity of all Biostatistics deliverables and the Study Report, as assigned by Biostatistics Management.
Serious Adverse Event/Experience (SAE) or Serious Adverse Drug Reaction (Serious ADR) – Any adverse drug experience occurring at any dose that results in
any of the following outcomes: death,life-threatening, that is, any event that (in the opinion of the Investigator) poses an immediate risk of death from that event, inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. 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.
Significant Communication – Any information that, in the opinion of the project team, may potentially affect the conduct of the study.
Site Assessment – Procedure to check that a trial site has the appropriate facilities, staff, and subject population to conduct a study in accordance with the Protocol and GCP. Also synonymous with Prestudy Assessment.
Site Close-out – Process of completing a clinical study at a trial site. Site close-out may start when the last subject has completed treatment/follow-up, but is not complete until all data queries relating to the site have been resolved.
Site Initiation – Procedures surrounding the start of a clinical study at a trial site (e.g., checking site facilities, delivery of clinical supplies, etc.). Unless waived by the client company, usually an initiation visit will be performed before any subjects are entered into a clinical study.
Site Visit Log – Document maintained at the trial site that records visits to the site by Sponsor representatives.
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).
Source Document – 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).
Source Document Verification – Visual check of the data presented in a CRF against source documents to ensure that the source data exist and have been transcribed accurately.
Sponsor – An individual company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. (
Standard Operating Procedure (SOP) – The detailed written instructions to achieve uniformity of the performance of a specific function.
Statistical Reviewer – Person who reviews the statistical aspects of the report. Should include product statistician and, as appropriate, Senior Biostatistician.
Study Coordinator – Person who generally handles the administrative responsibilities of a clinical trial at the site and acts as a liaison between the trial site and PPD.
Study Discontinuation – Premature closure of a trial site for operational reasons (e.g., poor recruitment, poor compliance), other reasons connected with the conduct of the study, or a change to the clinical development strategy.
Study Documentation – All documents supplied by an investigator or obtained by a client company that are required to ensure a site has been set up in accordance with GCP requirements.
Study Master File – Files containing documents and records (electronic or hard-copy) related to the general nature of the study, its development, and conduct.
Study Site Agreement – Documentation signed by the investigator or authorized person containing details of the work to be done, responsibilities of the investigator and client company, and general conduct of the study. Also synonymous with Statement of Agreement (SOA).
Study Supplies – Materials used in a study, including the investigational product(s).
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).
Subject Identification List – Confidential list maintained by the trial site containing adequate information to uniquely identify a subject.
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)
Tape – The term tape is used to refer to magnetic tape but could refer to other backup media such as CD-ROM.
Trefoil – Radioactive warning sign.
Trial Site – The location(s) where trial-related activities are actually conducted.
Unexpected Adverse Event – Any AE that is not identified in nature, severity, or frequency in the current labeling or investigator’s brochure, or that is not described in the risk information in the investigator’s brochure, Protocol, or general study plan.
Universal Precautions – Treating all human body fluids, specimens, and items contaminated with blood or body fluids as potentially infectious. Such material may contain bloodborne pathogens.
Validation – The process of independently verifying the accuracy and completeness of the programming related to Biostatistics and Data Management deliverables.
Validation Program – A program written to verify that a production program functions correctly.
Validator – The Biostatistics team member(s) assigned to validate the Biostatistics and Data Management deliverables.
Visual Analog Scale – A 100 mm line scale for indicating the level of pain being experienced by a patient, i.e., no pain to worst pain.
Whole Document Translation – A whole document translation may be required for documents that will become a reference document at a study site. Examples are the translation of a Protocol, study subject diary cards, investigator’s brochure, informed consent, etc.