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

92infbe given to the person signing; oral consent is possible if testifiedby signature of the witness; forms however represent only one partof the entire consent process and do not preclude detailed oralexplanations; GCP requires the following basic elements: statementthat study involves research, identification of experimentalprocedures amongst other procedures, expected duration, risks ordiscomforts, benefits, extent of confidentiality of records, compensationand medical treatments if injury occurs, whom to contactfor questions, statement that participation is voluntary and thatparticipation can be discontinued at any time without loss of benefits;the following additional elements apply when appropriate:unforeseeable risks (to fetus, embryo), participation terminated byinvestigator, additional costs to the subject, provision of significantnew findings, approximate number of subjects involved, no preemptionof other relevant laws, no limitation of other emergencymedical care; FDA permits an IRB to waive the requirement to signa written i.c. if: the research presents not more than minimal riskof harm to subjects, or involves only procedures for which writtenconsent is not normally required outside the research context;→ see also emergency consent waiver, legally acceptablerepresentative, patient information sheet, randomized consentdesign.informed consent application EMEA: “(abriged) application for aproduct essentially similar to an authorised product where consenthas been given by the existing marketing authorisation holder touse their data in support of this application; complete administrativeand quality data should be provided with consent to preclinicaland clinical data”; → see also bibliographical application,generic application, mutual recognition procedure.initiation visit This visit finalises preparatory activities at a centre;the monitor or clinical research associate discusses with theinvestigator and his coworkers details of the study conduct, explainsthe use of the different forms (case record forms, drug accountabilityforms, informed consent forms a.s.o.), and leaves allnecessary materials so that recruitment can be started right afterwards;→ see also prestudy visit.innovative chemical extension (ICE) Chemical variant of an alreadyexisting drug, usually with some extra therapeutic benefit; sometimesmisleadingly called mee-too.innovative new drug (IND) → see new chemical entity.inpatient Patient requiring hospitalisation for treatment (opp. outpatient).in-process control EC (IV): “checks performed during production inorder to monitor and if necessary to adjust the process to ensure