ࡱ> Z\Y{ ,bjbjBrBr 4Z  j8H4|0xxxxxSSSikkkkkk$lSSSSSxxUUUSXxxiUSiUUUx0^UU0U8 8U8USSUSSSSSXSSSSSSS8SSSSSSSSS : [Site Name] Consent Process Worksheet Sponsor: Site #: Protocol #: Investigational Drug: Patient Name:Patient Initials:Patient #: yesnonaStaff initialsHow was the patient made aware of the study? ( Brochure, advertisement, prior study patient, or patient called us ( Existing patient in care area or MD/nurse referralWas initial contact with patient ( Over the phone? ( In person? Date: _______________ Time: ____________Patient willing to talk to research coordinator regarding the study?Copy of letter, fact sheet and consent form provided to patient? Date Consent Given: ___________________ Letter Version Date: ___________________ Fact Sheet Version Date: ___________________ ICF Version # and Date: ___________________Explained study to patient?Emphasized voluntary participation?Read consent with patient?Patient took consent home?Verified that patient had enough time?Answered patients questions?Patient agreed to participate? Date: _______________Date and time informed consent signed by patient and investigator (or designee) Date: _______________ Time: ____________Copy of signed consent form given to patient? Date: _______________Copy of signed/dated informed consent form placed in patients medical record?Is patient eligible? Contact Information Best way to contact patient? (specify home phone, mobile phone, email, etc.)Details? (record phone # or e-mail address and best time of day to reach)Confirm if detailed messages can be left? 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