Page 55 - Terminology-Clinical-Research
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defines a study subject as male, female, or other. particular requirements implemented through software can
be consistently fulfilled.
Sham comparator arm: A group of participants
that receives a procedure or device that is made to be Somatic cell therapy medicinal product: Means the
indistinguishable from the actual procedure or device use of autologous (emanating from the patient himself),
being studied but does not contain active processes or allogeneic (coming from another human being) or
components. One of several arm types. xenogeneic (coming from animals) somatic living cells, the
biological characteristics of which have been substantially
Side effects: Any actions or effects of a drug or treatment altered as a result of their manipulation to obtain a
other than the intended effect. Negative or adverse effects therapeutic, diagnostic or preventive effect.
may include headache, nausea, hair loss, skin irritation,
or other physical problems. Experimental drugs must be Source: 1. The specific permanent record(s) upon which
evaluated for both immediate and long-term side effects. a user will rely for the reconstruction and evaluation of
a clinical investigation. 2. Sometimes used as shorthand
Signal of a serious risk: Information related to a serious for source documents and/or source data. Note: Accuracy,
adverse drug experience associated with use of a drug and suitability, and trustworthiness are not defining attributes of
derived from: (a) a clinical trial; (b) adverse event reports; “source.” The term identifies records planned (designated
(c) a post-approval study; (d) peer reviewed biomedical by the protocol) or referenced as the ones that provide
literature; (e) data derived from the post-market REMS the information underlying the analyses and findings of a
(risk identification and analysis system). clinical investigation.
Single blind masking: A type of Masking in which one Source data verification: The process of ensuring that
party involved in the clinical trial, either the investigator or data that have been derived from source data accurately
participants, does not know which participants have been represent the source data.
assigned which interventions.
Source data: All information in original records and
Single blind study: See Single blind masking. certified copies of original records of clinical findings,
observations, or other activities in a clinical trial necessary
Single group design: Describes a clinical trial in which for the reconstruction and evaluation of the trial. Source
all participants receive the same intervention. One type of
intervention model (design). data are contained in source documents (original records or
certified copies).
Single site in the Member State concerned: A trial is Source document verification: The process by which the
conducted in a single centre (clinical trial site) in the EU information reported by an investigator is compared with
Country concerned by the application.
the source records or original records to ensure that it is
SIR: Sponsor Investigator Research. complete, accurate, and valid.
Site investigator: A person responsible for the conduct Source document: Original documents, data, and
of the clinical trial at a trial site. If a trial is conducted records (e.g., hospital records, clinical and office
by a team of individuals at a trial site, the investigator is charts, laboratory notes, memoranda, subjects’ diaries
the responsible leader of the team and may be called the or evaluation checklists, pharmacy dispensing records,
principal investigator. recorded data from automated instruments, copies or
transcriptions certified after verification as being accurate
Social circumstances: A set of concepts that results from copies, microfiches, photographic negatives, microfilm or
or is influenced by criteria or activities associated with the magnetic media, x-rays, subject files, and records kept at
social environment of a person. the pharmacy, at the laboratories, and at medicotechnical
departments involved in the clinical trial).
Software: Computer programs, procedures, rules, and any
associated documentation pertaining to the operation of a Source(s) of monetary or material support for the
system. clinical trial: Organisation or Pharmaceutical Company
providing monetary or material support for the conduct of
Software validation: Confirmation by examination and the trial.
provision of objective evidence that software specifications
conform to user needs and intended uses, and that the Special populations: Subsets of study populations of
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