Polaris

SOP# SITE-009.0CompanyEffective Date: DD/MMM/YYII.ScopeThis SOP will apply to all informed consents and assents being used for the evaluation ofdrugs, devices, or biologics at Company.III.ProceduresIn this procedure, tasks designated to the Study Coordinator may also be accomplished bya Research Manager or Regulatory Documents Administrator.A. Reviewing the Draft Informed Consent1. Before the study begins, the Study Coordinator will contact the InstitutionalReview Board (IRB) to learn if that institution has specific formatting or wordingrequirements for informed consent in addition to those listed in the regulations.2. Before the consent form is submitted to the IRB, the Study Coordinator willreview the document to ensure that it is in compliance with the IRB’srequirements and with FDA regulations and ICH guidelines. The StudyCoordinator may use the Subject Information and Consent Form Checksheet(Attachment A) to accomplish this, but the completed form does not need to beplaced in the Regulatory Documents Binder.B. Obtaining Informed Consent from Adults1. The Investigator and Study Coordinator are responsible for ensuring that theinformed consent and assent, if applicable, have been approved by the IRB beforethey are used in a study and that the correct version of the documents are usedwhen the study is ongoing.2. Only those designated by the Principal Investigator on the Study ResponsibilitiesForm can obtain consent from a subject (Attachment B).3. The Investigator, Subinvestigator, Study Coordinator, or other delegate willexplain the study to the potential subject before any study procedures, includingscreening evaluations, are accomplished. The person who explains the study willallow enough time for the potential subject to read the consent form and willanswer any questions that are raised. If the person who provides this explanationis not a physician, he/she will ensure that a physician is available to answer thepotential subject’s questions, if necessary.4. The person obtaining the consent will ensure the following:a. All of the subject’s questions were answered.b. The subject understands the study requirements.c. The subject signed the consent voluntarily and without any changes.SITE-009.0.doc© 2004 by CRC Press LLC