1. Best Practice How is the informed consent process best documented? • Narrative note? • Checklist? Hybrid?

2. Sample ICF Process Note Example #1: 10/15/10 Mr. Jones presented to the clinic today for possible inclusion in study #RK-1672. Explained study and reviewed the informed consent form. Patient states he wants to take the consent form home to discuss with his wife. N. Ratchet, RN 10/16/10 9:00 am Mr . Jones returned today . Patient met with Dr. Smith to further discuss the 1672 study and Dr. Smith answered his questions. Mr. Jones, Dr. Smith and I signed the ICF. Mr. Jones was given a copy of the signed consent. N. Ratchet, RN Example #2: “Jane Doe, Study Coordinator, obtained consent Version XXXX from subject ABC on DD/MMM/YR. ICF was reviewed, subject was given time to ask questions. Patient was consented at 10:02 am, before any study procedures were performed and was provided with a copy of the signed consent.”

3. Additional Resources: Example #3: “The _____________research study was discussed with the subject/LAR. The study was explained in detail including all the contents of the informed consent document. The subject was encouraged to ask questions. All questions were answered to the satisfaction of the subject/LAR. The subject was given adequate time to read the informed consent form and the opportunity to discuss it. The IRB-approved informed consent document was signed without alteration by the subject. A copy of the informed consent document was placed in the subject record, and a copy was given to the subject. No activities specifically related to the research were started until after the execution of the consent. “

4. Sample ICF Documentation Checklist Example #4 Documentation of Consent Process Study Name __________________________ Protocol # _______________________ Patient # ____________________ Patient Initials _________________________ ___ Patient / subject was seen by delegation of principal investigator ___ Consents reviewed with subject ___ HIPAA form reviewed with subject ___ All questions / concerns were answered / addressed ___ Patient agreed to participate in study ___ Consents signed and dated Date:_______________ Time:_______________ ___ HIPAA form signed and dated (if applicable) ___ Copy of signed consent was given to patient/subject ___ Above process completed before any procedures for protocol were done   _______________________________________ ____________________ _________ Signature of Person Obtaining Consent Date Time

5. Hybrid Informed Consent NoteExample #5 Subject : ________________________ Study :______________________________ Informed Consent Process Documentation Please INITIALnext to “yes” or “no” by each line as appropriate (if no, you MUST explain in the notes section below). ______Yes ______ No Subject and/or LAR was given a copy of the ICF to read. ______Yes ______ No Ample time was given to the subject/LAR to read and ask questions. ______Yes ______ No All questions and concerns were addressed prior to signing the consent. ______Yes ______ No A copy of the consent form was provided to the subject and/or LAR. ______Yes ______ NoNo study procedures were performed prior to signing of the consent. The subject or subject’s LAR signed informed consent document version ___________________ on __________________________ at _____________. Date Time Notes: _______________________________________________ ___________ ________ Signature of Person Who Obtained Consent Date Time