Internal Monitoring Process and Site Preparation

Sites are selected monthly at random from the entire database of active JHM protocols.  If your protocol is selected, you will receive an e-mail and hard copy announcement from a compliance monitor, notifying you of the selection of your protocol, as well as the dates during which the routine visit will be conducted.  Also, you will be asked to provide a list of all consented subjects to the protocol, with the ID number and date of consent only.  From this list, a selection of 10-30% of subjects (or all subjects, if your protocol has enrolled 4 or fewer subjects) will be selected for review.

Before the Visit

In preparation for a site visit, you should review your regulatory information (IRB, FDA, any funding source, if applicable, SOPs), and make sure that you have all information complete and in a logical order.  Subject binders should also be reviewed.  This review should include: making sure that each subject has a complete, original signed consent form; documentation of the consent process (if available); documentation of eligibility; source documentation verifying eligibility; source documentation (including medical records, which may need to be ordered, if the subject was an inpatient) for protocol compliance; and all unexpected problems involving risk to the subject were reported.

During the Visit

The monitor will usually meet briefly with the PI and study staff at the beginning of the visit to introduce him/herself and explain the program.  After that, s/he will need a space to work.  Once the monitor has completed the review of the records, s/he will meet with the study staff and PI (if available) and go over any preliminary findings or recommendations, or ask for any clarifications s/he may need of the records.

After the Visit

Following the visit, the monitor will write up a report, which will be sent to the PI and study staff.  The PI will have approximately four weeks to respond, at which time the report (and response, if the PI chooses to respond), will go to the IRB for review.

The Vice Dean for Clinical Investigation and Assistant Dean for Human Subjects Research Compliance will also receive a copy of the report.