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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