Application Form & Guidelines
To download the Clinical Trial Application Form (PDF)*, click here.
- Each and every question is required to have an answer.
- If the question does not apply to your clinical trial, please mark, “NA”.
- If the question is answered with a “Yes” or a “No” please make sure that there are no further instructions required on that particular question (i.e. If Yes, please list … on a separate sheet).
- If Investigators listed on the application have not completed Human Research Protection Training, the application WILL NOT be processed. It will remain in the IRB office until either the investigator is removed from the application or the investigator has received training.
- The IRB office will invoice the sponsor directly for IRB Review fees. These fees ARE NOT for an approval. These fees are for reviewing and maintaining clinical trials only.
- If the sponsor has not paid the IRB fees within 90 days of being invoiced the clinical trial will be placed on “Administrative Hold”. This means that no other requests will be submitted to the committee for review (i.e. amendments to protocol, amendments to ICF, annual reports, etc.) Once the office has received payment of the invoice, the trial will be taken off of Administrative Hold. Any safety issues will be immediately submitted to the committee.
* PDF documents require Adobe Reader.