Submitting a New Clinical Trial

Submitting a new clinical trial study can be confusing and if not submitted properly may create delays. To assist users in accurately submitting new studies for review, the CTO has created an instruction guideline. This information is essential to ensure quick and accurate processing of clinical trial agreements, MCA development, Research Order Form (ROF) generation, and allows efficient and inclusive budget development and negotiation. It is essential that all required documents are included in your initial study submission, to allow the CTO to provide the best possible service to all departments.

Guideline for New Study Submissions

The step-by-step instructions guideline should be reviewed before submitting a new study into OnCore to confirm that all study information and documents have been obtained prior to submission.

Protocol Submission Guideline

Importance of Identifying the Sponsors

It is essential to identify the correct primary Sponsor and secondary Sponsor, to ensure the proper Office (CTO or DCG). Most importantly, the proper Sponsor must be identified in order for the MCA to be generated.

For studies where USC is a site for another institution, please identify the funding source as Sponsor.

For IITs, the Sponsor for billing purposes should still be identified as the funding source if applicable even when we are holding the IND. Within OnCore the term “Sponsor” is related to funding source in most circumstances.

Also, be sure to include the contact information including an email address for Sponsor within the comments section of the Management tab of the PC Console. This will allow the CTO team to efficiently and quickly contact the Sponsor to make introductions and advise of anticipated processing timelines.

Study Intake Contact

Talena Sanchez, Administrative Assistant , joined USC in 2011, gaining experience working in the call center for USC CARE, data entry operator for clinical research and currently the administrative assistant who manages the director of CTO’s calendar, team events and is responsible for the daily intake of OnCore submissions including the review of all essential study items for study acceptance.

[email protected]