Routine Visits and Directed Audits
Routine Monitoring Visit
A routine monitoring visit involves a planned examination of a JHM IRB approved protocol to assess and assure overall compliance with regulatory requirements and terms of IRB approval. Routine monitoring visits are scheduled to accommodate the PI and study team schedules. Although all IRB approved research is eligible for a routine monitoring visit the Compliance Monitoring Specialists give priority to the following types of research activities:
- Research for which a Hopkins’ study team member holds the IND or IDE number. In these cases, the FDA considers the Hopkins’ faculty member to be the sponsor/investigator and he/she must fulfill all of the associated FDA regulations. All projects for which a Hopkins study team member is the sponsor/investigator must have a monitoring visit before the IND or IDE is used in the project.
- Research that involves recombinant DNA, infectious agents and/or pathogens, biological toxins, or gene transfer or pathogens introduced into human participants.
- Research projects that are more than five years old and for which there is a recent change in the principal investigator.
Directed audits are requested either by a JHM IRB or by the Vice Dean for Clinical Investigation. The IRB may require an audit in cases where the IRB believes non-compliance with conduct of human subjects research has occurred. A directed audit may be required as a result of problems during or after FDA or other regulatory agency inspections, or in association with an investigation of a problem reported to JHU. All members of the Compliance Monitoring Team are involved in a directed audit. A directed audit must be completed as soon as possible.