220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

178subsubject identification code list syn. patient log list, patient log book;code used in lieu of the subject’s name; “to document that investigator/institutionkeeps a confidential list of names of all subjectsallocated to trial numbers on enrolling in the trial” and “to permitidentification of all subjects enrolled in the trial in case follow-upis required. The list should be kept in a confidential manner” (ICHE6, GCP); confidential list of names of all subjects allocated to trialnumbers on enrolling in the trial, kept by the investigator, to permitidentification of all subjects enrolled in the trial in case follow-up isrequired; the investigator must be able to identify the patient by itscode; it is necessary therefore to have a (confidential) list exhibitingthe codes as well as the complete identification of each patient (surname,given name, date of birth, usually also the sex); EC guidelinesrequest that the participation of a patient is marked in the medicalrecords; → see investigator, patient identification list.subject screening log syn. intent-to treat log; to document subjectsthat entered pre-treatment screening but that did not receivethe study medication; (“It may be relevant to provide the numberof patients screened for inclusion and a breakdown of the reasonsfor excluding patients during screening …” ICH E3, Structure andcontent of clinical study reports).substance → see old substance.substantial evidence FDA: “evidence consisting of adequate andwell-controlled investigations by experts qualified by scientifictraining and experience to evaluate the effectiveness of the druginvolved, on the basis of which it could fairly and responsibly beconcluded by such experts that the drug will have the effect it purportsor is represented to have under the conditions of use prescribed,recommended, or suggested in the proposed labelling”.summary of product characteristics (SPC, SmPC) syn. data sheet;general information for prescribers on the correct use of a drug includingrisks; necessary for marketing authorisation within the ECand annexed to the Periodic Safety Update Report; the SmPCincludes the name of the proprietary product, qualitative andquantitative composition (ingredients, excipients), internationalnonproprietary name, the pharmaceutical form, pharmacologicalproperties, therapeutic indications and contra-indications, warnings,shelf-life, storage conditions, and other particulars; → seealso company core data sheet, patient information leaflet.sunset clause Marketing authorization of a product expires if the medicinalproduct is not on the market for more than 3 years; → seealso renewal.supplementary protection certificate (SPC) Certificate for extendingpatent life of innovative pharmaceutical products, based on