Regulatory Assistance

Besides the protocol, both the IRB and study sponsors require the appropriate documents be completed and submitted before a study can be started.  The Regulatory Specialists within the Clinical Research Office (CRO) can answer questions and provide assistance to investigators and research coordinators who are unfamiliar with the processes.

Each investigator must comply with FDA and university requirements.  Failing to meet the regulations can have legal and financial implications for the individuals conducting the research as well as the institution associated with the research activities.

Meeting the regulatory requirements is an essential part of doing clinical research but it may seem intimidating.  Guidance is available for investigators from the CRO.

Investigators who do not have access to a research coordinator may request assistance with the development and completion of the necessary forms, including the following: 

• HRP-503 Template Protocol (for investigator initiated studies)
• HRP-508 Supplement to Sponsors Protocol (for industry sponsored studies)
• HRP-502 Consent Documents
• HIPAA Forms
• Authorization of Fee Collection for IRB Review (for industry sponsored trials)
• Form FDA 1572 and other sponsor required documents

Regulatory Specialists are available to assist investigators with a wide range of regulatory issues.  They will work directly with the investigator, the sponsor, and the IRB, if needed, as well as those members of the CRO completing the budget and contract negotiations, to accurately complete the necessary forms for IRB submission.