Professional Development, Responsible Conduct, and Inclusion Workshop
to
Policies & Procedures
The Clinical Trials Office has created and compiled materials for research investigators about the processes, resources, and references available.
PI Pre-Negotiation Interview Form
Research Policies
Human Subjects, Animals Subjects, Environemtnal Health & Safety
- Human Subjects Policies and Procedures (HSPP)
- Department of Animal Resources Investigator Manual (IACUC)
- Biorepositories Policy (BP)
- Environmental Safety Standard Operating Procedures (Forms & SOP’s)
- Stem Cell Research Oversight (SCRO)
- Scientific Misconduct Policy (SM)
Effort, Conflict of Interest, Intellectual Property
Process for Agreements
Clinical Trial Agreement Process Confidentiality Agreement Process
Medical Coverage Analysis Process (Non-Industry)
Clinical Trials Office Billing & Fees
| Fee Schedule | Frequently Used Fees |
| CTO Overhead | CTO Billing FAQ |
Investigational Drugs
The investigational drug service prepares and dispenses medications used on approved clinical trials, both for Keck Medical Center and LA County+USC Medical Center.
- IDS Forms and Policies (requires log-in)
- Scheduling monitoring visits with the IDS Pharmacy
For further information, contact IDSPharmacy@med.usc.edu or call (323) 865-3538.
Research at LAC
Effective April 1, 2015, USC and LAC+USC have established the following procedures for the conduct of clinical research by USC workforce members at LAC+USC.
• IRB Approval: Protocols submitted to the USC IRB that propose access to LA County patients, patient records, services or other resources will be forwarded by the IRB to LAC+USC for review.
• Medicare Coverage Analysis (MCA) and Charges for Services: MCA and review of budgets will be conducted by the USC Clinical Trials Office using standard procedures. When LAC+USC is identified as a location for services, costs of clinical services will be based on the LAC+USC charge master.
• Research Order Forms: A Research Order Form (ROF) for LAC+USC mirrors the one currently used by the USC CTO.
• Requesting Services: When obtaining services at LAC+USC, Study Teams must utilize the following steps:
1. Download the study-specific ROF from TRUE when requesting any and all study-related services from LAC+USC using standard hospital order forms (or, in the future, through the LAC+USC EHR). Do not make copies of the ROF, they are not legible when faxing or emailing to LAC+USC.
2. Check “LAC” to identify the services were ordered at LAC+USC Medical Center
3. Each ROF must be legible. If the ROF is not legible, please contact CTO to provide a multi-page ROF.
4. Any handwritten instructions on the ROF must be legible. Services should only be written on the ROF, if they are medically necessary and should be billed to the Sponsor.
5. Email the legible ROF to LAC+USC Expenditure Management Office:
To: Mindy Wang mwang@dhs.lacounty.gov
Cc: Maria Renteria mrenteria@dhs.lacounty.gov and Kathy Bustos kbustos@dhs.lacounty.gov
• Payment for Services: Upon receipt of a ROF, LAC+USC, Expenditure Management staff will verify that services were provided and bill USC’s Sponsored Projects Accounting for those services. SPA will bill the appropriate study account.