Bookkeeping

Each study has 3 broad categories of binders

1. Individual patient binders - this keeps all records related to the individual patient's participaion in that study, including their ICF, printed copies of EMR notes, worksheets, and so on

   • If the study is double-blinded, there will be blinded and unblinded patient binders kept separately

   • Some sponsors will send pre-made binders with section dividers, etc.

   • For those that do not, you need to make your own

2. Screen failure binder - this contains all the ICFs of patients who signed consent, but ended up screen-failing on the table. We keep their ICFs but do not follow up with the patients afterwards. (Some studies may require a short term follow up for screen-failed patients for safety reasons.)

3. Regulatory binder - this lives in Cathy's office, and contains all the regulatory documents related to the study. This includes things like training logs, DOAs, etc.

   • Some studies might have a separate binder for device accountability logs, but that is rare

Bookkeeping Tips

• Always make a copy if the ICF for HIM (Health Information Management). They will scan the ICF onto the patient's chart.

  • There is a stash by the door of Penny's office, we take turns periodically bringing it to HIM

  • HIM is located in the main hospital right across the cafeteria

• Print all relevant notes from Epic to file in the patient's binder as source documents

  • Including things that show "due diligence". E.g. if a patient cancels their visit, print the page that says so. This way, if the patient ends up missing the visit or their visit is out of window, it shows that it is not due to coordinator negligence.

Storr Boxes

Storr is a record management service that our team uses to archive documents from studies that have closed out. They are stored securely off-site.

Cleaning up old binders, etc. into Storr boxes and arranging for them to come pick up is not a frequent occurrence. You can expect to have to do it around once a year or so.

See "Records Management" folder in the shared drive for more details, and Kyle is a good person to consult as he has a lot of experience with this.