Polaris

CompanyStandard Operating Procedure: MON-004.0Title: Developing Informed Consent FormsEffective Date: DD/MMM/YYSupersedes: N/AAUTHORName:Title:Department:Signature and Date:APPROVED BY DEPARTMENT HEAD QUALITY ASSURANCEName:Title:Department:Signature and Date:REVISIONSNo. Section Pages Initials/DateI. Purpose• To describe the information required to be included in all informed consentdocuments developed by Company.• To provide ancillary information to facilitate preparation of acceptable informedconsent forms.II.ScopeThis SOP will apply to all informed consent documents developed by Company.MON-004.0.doc© 2004 by CRC Press LLC