Principal Investigators play a pivotal role in USC research projects, overseeing their direction, ensuring adherence to ethical standards, and fostering collaboration among team members. Their leadership and expertise are crucial for driving innovation, maintaining research integrity, and ultimately advancing knowledge in their field. Below is a list of common PI post-award responsibilities.

• Executing the project as outlined in the funded proposals.
• Carrying out the project’s financial plan as presented in the proposal.
• Making changes to the project’s financial plan following sponsor and/or USC’s policies and procedures.
• Reporting project progress and submitting deliverables to the sponsor as outlined in the terms of award.
• Responding promptly to staff requests for approvals, information, or decisions.
• Ensuring that an accurate record is maintained of project-related expenses.
• Selecting, training, and evaluating project staff and students.
• Complying with all USC policies and procedures, maintaining high standards of research integrity, and protecting the welfare of research subjects.
• Complying with all applicable sponsor rules, regulations and/or terms and conditions of the award.

Although the PI is usually assisted by administrative staff, the management of project funds and the ultimate responsibility for the financial and administrative management of the project rests with the PI.

Departmental Research Administrators are responsible for managing the administrative aspects of research projects, ensuring compliance with funding regulations, and facilitating smooth communication between researchers and funding agencies. Below is a list of departmental research administrator post-award responsibilities.

• Prepare budgets (including any satellite budgets), financial transactions (e.g., cost transfers, payroll, requisitions) and certify that cost sharing is documented.
• Review and approve financial transactions.
• Complete necessary adjustments to award charges and/or payroll
• Review the terms and conditions of the award to determine if any prior approvals are needed and notify DCG if /when prior approvals are requested.
• Prepare effort reports. 
• Initiate supplier contracts and change orders in Workday and ensure all requested information is complete.

Schools are responsible for ensuring that administrative support is provided to investigators for the fiscal and administrative management of sponsored projects. In some schools, this support is provided centrally by the school as a service for all of the school’s PIs. In other schools, departments, centers, and/or institutes provide this service locally. It is the school’s responsibility to ensure that no PI is left without administrative support, that all PIs are aware of where to obtain support, and that sufficient resources are available to meet the needs of PIs. Below is a list of  school- post-award responsibilities.

• Approve re-budgeting requests.
• Certify that cost sharing is documented.
• In the absence of the PI (e.g., transfer, long-term absence) prepare and submit technical reports to the sponsor and DCG.
• Approve PI changes.
• Approve PI Transfers.

The USC Department of Contracts and Grants is tasked with aiding Principal Investigators (PIs), Departments, and Schools in negotiating and executing agreements and amendments. They provide guidance on compliance with the terms outlined in sponsored agreements and facilitate the process of seeking sponsor prior approvals when necessary. Below is a list of  DCG post-award responsibilities.

Award Acceptance and Set-Up

• Negotiate terms and conditions with sponsor.
• Confirm acceptance of exceptional terms and conditions.
• Approve award terms and conditions and if applicable, execute award/agreement.
• Confirm that regulatory compliance approvals are in place.
• Enter award information in Cayuse SP system.

Compliance

• Forward prior approval requests to the sponsor, when sponsor approval is required.
• Obtain sponsor’s decision regarding changes to the project and update university systems, as necessary.
• Assist PI/Dept Admins with questions regarding interpretation of terms.
• Assist with the non-financial closeout of the Agreement.

Outgoing Subawards

• Upon receipt of Workday, request, prepare, negotiate, and sign subcontracts/subawards and subsequent modifications.

The Office of Sponsored Projects Accounting manages the post-award financial aspects of university-sponsored research, including the setup and modification of Award, Award Line, and Grant Worktag information. They handle detailed budget planning and reallocation, process invoices, manage accounts receivable, and generate financial reports. Additionally, they facilitate expense transfers to ensure accurate and compliant financial administration of sponsored projects. Below is a list of  SPA post-award responsibilities.

• All set up of awards in the Workday system.

• Financial Management of Awards

  • Financial Reporting

  • Invoicing

  • Ensuring Payments

  • Rebudgets

  • Cost Transfers

For more information please visit SPA’s Website

Complete Grants Management Training:

Required for all USC personnel in a Principal Investigator (PI) or Co-Principal Investigator (Co-PI) role (as defined by the sponsor). Please confirm completion by looking up the PI in the “Admin” section of Cayuse SP and reviewing the section for “Training & Certifications.”

Complete Conflict of Interest Training:

This training is required for all awards which have funding from a Public Health Service sponsor (e.g. DHHS, NIH, SAMSHA, HRASA) for all personnel in an investigator role. “Investigator” means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research. This must be completed every 4 years.  PI and Dept Admins can confirm completion by checking in Cayuse SP under the “Admin” section and reviewing “Training & Certifications.”

Conflict of Interest Review Committee (CIRC) Approval:

Required for all awards where the Cayuse indicates “Yes” to conflict of interest on the Regulatory Compliance Tab. Please request confirmation of Conflict of Interest Committee approval from PI/Dept Admin and provide it to your DCG officer.

Complete Medicare Coverage Analysis (MCA):

Required for all awards where there are patient care costs. Please work with the Clinical Trials Office and route through the Oncore System. Once the MCA is final and the Award/Amendment is final DCG will complete the Consistency Checklist in I-Star so approval of your study can be finalized in Oncore and you can begin to enroll patients.

Complete IRB Approval:

Required for all awards with human subjects. Please promptly provide this to your DCG Officer upon receipt. For additional guidance on how to request IRB approval please visit the IRB website. Please note that all IRB approvals will need to be connected with the Cayuse proposal or award Project # connected to the IRB approval. DCG has created a quick guide to assist: How to Link an IACUC/IRB Protocol to a Cayuse SP Proposal or Award.

Complete IACUC Approval:

Required for all awards where animal subjects are included. Please promptly provide this to your DCG Officer upon receipt. For additional guidance on how to request IACUC approval, please visit the IACUC website. Please note that all IACUC approvals will need to be connected with the Cayuse proposal or award Project # connected to the IACUC approval. DCG has created a quick guide to assist: How to Link an IACUC/IRB Protocol to a Cayuse SP Proposal or Award.

Complete IP-ACT:

Required for all personnel on federally funded agreement in order to comply with the Bayh-Dole Act. For additional information on this requirement, please review Bayh-Dole Act Obligations for Universities.  PI and Dept Admins can confirm completion by checking in Cayuse SP under the “Admin” section and reviewing “Training & Certifications.” In the event that this has not been completed, please contact your DCG Officer and they will generate an e-mail to the faculty/staff member so that they can complete.

The HHS regulation 42 CFR Part 50 Subpart F, Promoting Objectivity in Research (FCOI regulation), establishes standards that provide a reasonable expectation that the design, conduct, or reporting of Public Health Services Sponsors  (e.g. DHHS, NIH, SAMSHA, HRASA) funded research will be free from bias resulting from any Investigator’s conflicting financial interest. HHS requires recipient institutions and their investigators to fully comply with all FCOI requirements.

For more information about this policy please feel free to review:

• NIH Financial Conflict of Interest – https://grants.nih.gov/grants/policy/coi/index.htm
  
  
• 42 CFR Part 50: https://www.govinfo.gov/content/pkg/FR-2011-08-25/pdf/2011-21633.pdf

In order to comply with FCOI requirements the following must be completed:

Complete Disclose:

Required for all personnel in an investigator role. “Investigator” means the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research. This must be completed annually. DCG can confirm completion by looking up the investigator in the “Admin” section of Cayuse SP and reviewing the “Training & Certifications” section. 

Complete Conflict of Interest Training:

This training is required for all personnel in an investigator role. “Investigator” means the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research. This must be completed every 4 years.  

On September 16th, 2016, The The U.S. Department of Health and Human Services issued a final rule that sets forth expanded requirements for registration and results information to clinicaltrials.gov for FDA-regulated drug, biological, and device products.  Simultaneously, NIH issued a complementary policy requiring registration and results information to clinicaltrials.gov for all NIH-sponsored clinical trials, regardless of whether the trial is covered by the HHS Final Rule.

USC’s IRB’s Policy further states:

Registration and results reporting are required for applicable clinical trials; however, ClinicalTrials.gov allows voluntary reporting of other studies that:

• Are in conformance with any applicable human subject or ethics review regulations (or equivalent) and
• Are in conformance with any applicable regulations of the national (or regional) health authority (or equivalent) Investigators may choose to register a study that is not an applicable clinical trial as a condition to publish study results in a journal. FDA regulations require reporting of results from registered trials.

The Responsible Party must generally report results no later than 12 months after the trial completion date. Results must include participant baseline characteristics, participant flow diagram, outcomes, and adverse events. Instructions for submitting results are available at ClinicalTrials.gov. FDA also requires sponsors or investigators to certify compliance with ClinicalTrials.gov registration when submitting certain applications to the FDA. Form FDA 3674 is used to certify compliance. 

The text above may be used in NIH applications requiring a statement of USC policy.

Registration is required by law and USC IRB policy for:

• FDA Clinical Trials defined as intervention studies that include drugs, biological  products, and medical devices;
• NIH Clinical Trials defined as biomedical and behavioral studies of human subjects;
• Publication of research studies that assigns human subjects to health-related interventions and evaluates their outcomes.  Other public registries are also available to meet criteria for ICMJE and WHO; and
• Reimbursement of Medicare claims for items and services in clinical trials that are qualified for coverage.

Registration of an applicable clinical trial must be submitted no later than 21 days after enrollment of the first participant, and the data that must be reported includes

• Participant Flow
• Demographic and Baseline Characteristics
• Primary and Secondary Outcomes
• Results of any Scientifically Appropriate Statistical Tests
• Adverse Event Information

Non-compliance of these requirements may result in civil monetary penalties, withholding/recovery of federal funds, and/or withholding of publications.

Principal Investigators are responsible to register their studies prior to participant enrollment in the Protocol Registration System (PRS).

Contacts to Request a PRS User Account

For Cancer Center Studies

• Victoria Soto
• Email:  Victoria.Soto@med.usc.edu
• Phone:  (323) 865-0432

For Non-Cancer Studies & All Other Requests

• Jean Chan, HSC Associate Director
• Email:  jeanbcha@usc.edu
• Phone:  (213) 764-1552

Additional Information

• Registration Steps
• Requirements Summary
• Responsible Party
• Clinical Trials at USC

Training Resources

• Final Rule Webinar Series (Overview of the Final Rule & Information Requirements)
• How to Submit Results Data (Overview of Each Results Module)
• Example Studies

STEPS TO REGISTER STUDY ON CLINICALTRIALS.GOV