Polaris

CompanySubject Information and Consent Form ChecklistProtocol #: Investigator/Site #:Protocol Date orVersion Number:Reviewer:Sponsor:Date:Element of Informed ConsentAdequateNotadequateNotapplicableSimple explanation of the consent processStatement that the study involves researchIdentification of any experimental proceduresPurpose of the research (always includes an evaluation of safety)Expected duration of the subject’s participationFrequency of visits to the study site and length of stay for eachvisitList of study proceduresA description of what will be expected of the subject, includingbefore entering the study (e.g., refrain from smoking and/oralcohol, discontinue some medications, etc.)Identification of experimental procedures and drugsProbability of random assignment to treatment arms, includingplaceboAcknowledgment of the use of placeboStatus of test article or drugList of foreseeable risks or discomforts; and when possible, thelikelihood, severity, and duration of those risks.List of benefits to the subject or to others that can be reasonablyexpected, including the possibility of no guarantee of benefits, ifapplicableICF Review.doc© 2004 by CRC Press LLC