1. Best Practice How is the informed consent process best documented?
Hybrid refers to a combination narrative note/checklist.
How is the informed consent process best documented?
Narrative note?
Checklist?
Hybrid?

2. Sample ICF Process Note
So what are good examples of informed consent process documentation? Example #1 represents medical record entries provided as examples of informative documentation of informed consent process in the GCP Question and Answer Guide.
The 2nd example is one developed by a Quintiles taskforce working on developing monitoring tools for the CRA tool box. You can see that the first example is the best at “telling the story”. The second example is proposed as a guideline for a note that would cover all the salient points a CRA would look for when reviewing ICF process notes, and could be used as a template for sites to use in writing these notes. Using a template increases the likelihood that all important points will be covered, but may lack important detail.
Example #1:
10/15/ Mr. Jones presented to the clinic today for possible inclusion in study #RK 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.
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 is an example of a “canned” or boiler plate note that some sites use, that may have one or often more blanks for the site to fill in to customize the note to the individual subject. Such an approach to documenting the consent process is often adopted to save time.
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
Here’s a sample of ICF documentation using a checklist approach. These types of notes are found as stand alone notes or may be seen as a section of the screening source document worksheets. All staff need to do is add check marks for fill in the blanks. With this type of ICF process documentation, anything in the process that isn’t covered in the checklist unfortunately often doesn’t get documented.
Example # 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 Note Example #5
Subject : ________________________ Study :______________________________
Informed Consent Process Documentation
Please INITIAL next 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 ______ No No 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
This example represents a hybrid approach to documenting the informed consent process. Some fill in the blanks, some check marks and a place to add a narrative in the “Notes” section.
These examples are only a few of the kinds of informed consent documentation you’re likely to encounter as a monitor.