Protocol Submission

There are many details entailed in preparing and submitting a protocol to the Pediatric CTRC. The links in this section will assist you with the forms and instructions you need. Please go to this link to get the updated instructions and documents needed for your application - Updated CTRC application instructions.

Generally you must start with a good basic knowledge of the science in the field you want to study. If possible you should also have a hypothesis you have formulated. If not, our biostatisticians can assist you with this. Use the current electronic protocol application, and complete all sections to the best of your ability. If you need help, the form has an instruction document embedded in it that you can open through the icon on the front page on the left. The application also lists names and phone numbers of CTRC staff members that can assist you with specific areas.

You'll need to touch base with the following CTRC staff members prior to your application being circulated for scientific review. These are: the biostatistics department, the Research Subject Advocate, the Informatics department and the CTRC Nursing. Individuals will help you to determine if the protocol in question can be carried out at our Center. If so, then the application is sent to reviewers for scientific content and scheduled for the next available SAC review meeting. The Administrative Assistant will give you a confirmation on the date and specific time for this review. You must be present for the review or it will be rescheduled.

Also be sure that you apply to COMIRB either before or at the same time you are applying to the CTRC, as you'll need both approvals in order to receive a CTRC number that allows you to begin enrolling subjects.

The Primary Investigator or their co-investigator(s) who can speak to the detail of the protocol application must attend the Scientific Advisory Committtee(SAC) meeting or the review of their protocol will be postponed. All fellows and students must attend the meeting with their mentors.