OGC is responsible for all administrative and financial management of Clinical Trials, to ensure the smooth conduct of the studies, and acts as the official liaison between AUB (the PI) and the Sponsor on administrative and financial queries. OGC also monitors sponsored Clinical Trials for compliance with Sponsor terms and conditions and University policies, and handles financial and administrative queries and matters including budget modifications, budget re-allocations, no-cost extensions, renewals, and reporting.
I. Responsibilities of the Principal Investigator (PI)
1. Clinical Trial Implementation
Upon signature of the Agreement, the PI may start the Clinical Trial implementation. The PI should abide by all clauses of the Agreement, and will be responsible for the performance of the scientific, technical, financial and administrative duties normally associated with the Clinical Trial including the submission of CRFs as required by the Sponsor. The PI is responsible for administering the trial in accordance with the signed Agreement terms and conditions and the approved clinical research protocol as well as in compliance with University policies.
2. Submission of Reports
The PI is responsible for cooperating with the Sponsor's CRA responsible for the Study, who will have regular site visits, and is responsible for providing the sponsor agency with reports detailing the trial administration process, patient recruitment, screening failures, drug administration among other requested information as agreed with the Sponsor.
3. Budget Expenditures
The budget included in a Clinical Trial Agreement is an integral part of the Agreement, and thus PIs should adhere to the budget for needed expenditures to successfully implement the CT. The PI must ensure compliance with the budget ceiling and line items as defined in the Agreement.
II. Responsibilities of OGC
Administrative and financial management of the trial is regularly performed to ensure that AUB and the PI are adequately compensated for in terms of resources used during the investigation, including personnel, supplies, hospital services, and administrative and indirect costs.
1. Account Set up
Upon the signature of the clinical trial Agreement, OGC opens the account (cost center) for the clinical trial under the PI’s name and the PI’s faculty, and requests the first payment from the Sponsor as agreed upon in the Agreement. OGC will give specific directives on the account and budget details.
If cost share is committed on the clinical trial, OGC will follow up with the PI and the Office of the Comptroller to ensure its recording, documentation and reporting.
2. Monitor Patient Recruitment and Expenditures
Throughout the duration of a Clinical Trial, OGC follows up with the PI to monitor the number of patients recruited to ensure that expenditures on account are charged in accordance with the approved budget. This will ensure expenditures are made in line with the actual number of recruited patients.
3. Relations with Sponsor Agencies
OGC develops and maintains positive and effective contacts with Sponsor and the Sponsors' CRAs, and handles correspondence with them on various administrative aspects of the Clinical Trial. It is the Sponsor’s responsibility to ensure the reliability and validity of the research data and the statistical and ethical correctness of the results through site audits, inspections and investigator’s reports.
4. Follow-up and Submission of Reports
OGC will follow-up and ensure the timely submission of final report on Clinical Trials to Sponsors. Reports submitted to sponsors are made, while safeguarding and protecting confidentiality and excluding any personal identifiable information.