Polaris

SOP# MON-004.0CompanyEffective Date: DD/MMM/YYIII.ProceduresA. Informed Consent Form (ICF) Template AuthorThe template for an Informed Consent Form may be developed by an In-HouseClinical Research Associate or Clinical Research Associate, as long as someone at ahigher level approves the final document.B. Required Elements and Additional ConsiderationsThe Informed Consent Form will be developed so that all basic elements of consentand the applicable additional elements are contained in the document according to theregulations. Because the ICH guidelines make no distinction between basic andadditional elements (i.e., these guidelines state that all basic and additional elementsare required for all consent forms), Informed Consent Forms being developed fortrials that will have study sites outside the United States will be developed accordingto the more strict ICH guidelines.In addition to the basic elements of consent, the author will also consider thefollowing points when developing the document:1. The information must be given to the subject or the subject’s representative inunderstandable language (i.e., usually an eighth-grade reading and comprehensionlevel). Ultimately, the preferences concerning style, format, and specific wordingrequired by the IRB will be followed.2. The informed consent must not include any language suggesting that the subjectrelinquishes any legal rights or that he/she releases the Investigator, sponsor, orinstitution or their agents from liability for negligence.3. The content of the informed consent document must present the benefits and risksof the research in such a manner that the subject (or representative) can make aninformed choice concerning his/her participation in the study.C. FormatThe ICF template author will consider the following items:1. The first page will be on the institution’s letterhead or include the followinginformation:a. Name and address of the institutionb. Name and address of the Principal Investigatorc. Name and number of the protocol2. There will be an appropriate heading for each paragraph.3. The date of issue or revision will be included on every page.4. There will be a space on each page for the subject’s initials (in addition to thesignature line for the entire document).5. Each page will be numbered (e.g., Page 2 of 3).MON-004.0.doc© 2004 by CRC Press LLC