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Policy No: 2111
Responsible Office: Clinical Trials
Last Review Date: 03/29/2024
Next Required Review: 03/29/2029
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Policy No: 2111
Responsible Office: Clinical Trials
Last Review Date: 03/29/2024
Next Required Review: 03/29/2029
Clinical Trials
1. Purpose
The 黑料天堂 and USA Health System is committed to conducting scientifically sound and ethical clinical research. The Clinical Trials Office (CTO) is a USA Health system wide office providing support to investigators conducting clinical studies, including industry-sponsored, investigator-initiated, and federally funded trials. The Director of the CTO reports to the College of Medicine’s Associate Dean of Research. The purpose of this policy is to specify which studies are to be managed by the CTO, what activities the CTO is responsible for, and where to find specific policies and procedures related to clinical trials.
2. Applicability
This Policy and Procedure applies to Principal Investigators, Co-Investigators, Sub-Investigators, Clinical Research Coordinators, or any other USA or USA Health personnel who perform tasks related to clinical trials. This Policy and Procedure will also apply to non-USA personnel who perform clinical trials research on USA property or facilities. Research performed in any facilities owned and managed by USA or USA Health are subject to this policy. Exclusions apply to USA property that is leased by a private party.
3. Definitions
Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Clinical Trial Agreement (CTA): A legally binding agreement that governs the conduct of a particular study and sets forth the obligations of each party to the agreement.
Confidential Disclosure Agreement (CDA): A legal contract through which the parties involved in executing the agreement are obligated not to disclose any proprietary information covered under the CDA. A CDA outlines the scope of the confidential information the parties wish to share with each other for specified purposes. A CDA is also known as a nondisclosure agreement (NDA), confidentiality agreement or secrecy agreement.
Contract Research Organization (CRO): A person, company, or other organization that contracts with the sponsor to provide specific services in support of a clinical trial. A CRO often serves as a liaison between the research sponsor and the research site.
Principal Investigator: The individual of record who assumes the authority and responsibility for the conduct of a clinical study. In the event an investigation is conducted by a team of individuals, the principal investigator is the responsible leader of the team. “Sub-Investigator” includes any other individual member of that team.
Service Center: Service Center is a broad term used to define an operating unit that provides goods or services for a fee based on a rate schedule.
Sponsor: An individual, pharmaceutical company, government agency, academic institution, private organization, or other organization who takes responsibility for and initiates a clinical investigation.
4. Policy Guidelines
Any investigators at USA proposing to conduct a research study, including investigator-initiated or industry-sponsored trials, must first consult with the USA Clinical Trials Office (CTO) if their study meets any one of the following criteria:
- Studies meeting the above definition of a clinical trial;
- Studies requiring the study to pay for clinical tests, visits, procedures, etc.;
- Studies funded by a pharmaceutical or biomedical company.
The CTO consists of specifically trained, dedicated study coordinators, lab assistants, regulatory coordinators, and budget coordinators. All Clinical Research Coordinators (CRCs) and support staff involved in clinical trials are employees of the CTO. They are managed and assigned to studies by the Director of the Clinical Trials Office. Day-to-day supervision of CRCs and research support staff will be the responsibility of the CTO, with input from the Principal Investigators.
Services provided by the CTO include, but are not limited to:
- Contract/budget negotiation;
- Coverage analysis;
- Regulatory compliance;
- IRB submissions;
- Assignment of Clinical Research Coordinators (CRCs);
- Accounts payable/receivable;
- Sponsor/CRO communication and site visits;
- Study participant recruitment;
- Protocol execution;
- Data entry;
- ClinicalTrials.gov reporting;
- Investigational product storage and maintenance.
As a service center of the 黑料天堂, the CTO provides these services for a fee based on a rate schedule. The CTO will negotiate administrative fees in the Clinical Trials Agreement at the start of the study.
5. Procedures
Before agreeing to participate in a research study meeting the criteria outlined above, researchers must first consult with the Clinical Trials Office Director. If both parties agree to proceed with the study, the CTO staff will communicate with the sponsor/contract research organization and lead all necessary study procedures during the start-up, maintenance, and closure of the study, including the following specific procedures:
5.1 Prior to Study
5.1.1 If researchers are sent a Confidential Disclosure Agreement or Nondisclosure Agreement, this must be sent to the CTO for review and execution.
5.1.2 If researchers are sent a Feasibility Questionnaire, this must be sent to the CTO for review and completion.
5.1.3 Discussions on study feasibility or site qualification should be directed to the CTO. The CTO will be present for any feasibility or site qualification visits with the sponsor/CRO. If there is no feasibility visit, an internal discussion will take place to determine feasibility.
5.1.4 The study budget and contract negotiations will be managed by the CTO. The Clinical Trial Agreement (CTA) must be sent to the CTO for review and execution.
5.1.5 CTO will assign a Clinical Research Coordinator (CRC) to the study.
5.1.6 CTO will create initial IRB submission and prepare documents required for submission.
5.2 During the Study
5.2.1 Administrative fees negotiated in the study budget will be transferred to the CTO from the study fund.
5.2.2 The CTO will provide Clinical Research Coordinator (CRC) support for study participant recruitment and protocol execution. Time and effort of the CRC will be charged to the study fund.
5.2.3 The CTO will manage all study participant expenses and reimbursements, sponsor invoicing and payments. Expenses will be paid from the study fund.
5.2.4 Any budget and contract amendments will be negotiated by the CTO.
5.2.5 All study sponsor/CRO monitoring visits, including Site Initiation Visit (SIV) and Interim Monitoring Visits, will be scheduled and attended by CTO staff.
5.2.6 All IRB submissions and communication, including continuing review and study amendments will be the responsibility of the CTO.
5.2.7 Regulatory binders will be kept and maintained by CTO regulatory staff.
5.2.8 Investigational product storage will be managed by the CTO, either internally or contracted through a USA Pharmacy.
5.2.9 CTO will keep the study PI informed on the status of the study and individual study subjects.
5.3 Study closeout
5.3.1 The CTO will manage the close-out process, including IRB submission, sponsor/CRO closeout, and financial reconciliation.
5.3.2 The CTO will manage long term storage of study documents.
5.3.3 All residuals in the study fund after close-out will remain with the originating department
Detailed policies and procedures for the conduct of research performed through the Clinical Trials Office are maintained on an internal secure shared drive and can be obtained by contacting the Clinical Trials Office.
The Clinical Trials Office follows guidance as set forth by the 黑料天堂’s Institutional Review Board (IRB). The CTO staff and all researchers should be familiar with the USA IRB policies. Researchers requesting review by an external IRB must also be familiar with their policies and seek acknowledgement from the USA IRB prior to external IRB submission.
6. Enforcement
The 黑料天堂 Clinical Trials Office is responsible for this policy and for ensuring that the 黑料天堂 personnel are aware of its content. Noncompliance with this policy will be addressed by the College of Medicine or University Health leadership.