Protocol Management Services | Specific Aims | Clinical Research Team Managers | Contract and Budget Services | Regulatory Processing | Subject Recruitment | Data Collection | Clinical Research Data Coordinators | Clinical Trial Informatics | Web-Based Clinical Trial Access
The Clinical Trials Office Shared Resource provides a centralized resource of comprehensive management services for the OSUCCC investigators to conduct successful clinical trials in a methodologically sound, expedient and cost-effective manner. The CTO supports the OSUCCC member investigators conducting cancer-related clinical trials by providing the following services:
Protocol Management Services
The Clinical Trials Office (CTO) was formed in 1998 as a shared resource of the Ohio State University Comprehensive Cancer Center (OSUCCC) providing centralized administration of cancer clinical trials conducted by the Arthur G. James Cancer Hospital and Richard J. Solve Research Institute physicians, researchers and clinical staff. The mission of the CTO is to provide centralized resources to the investigators to successfully conduct cancer clinical trials in a methodologically sound, compliant, expedient and cost-effective manner. The conduct of clinical cancer research has become increasingly complex due to multiple investigational drug combination treatments, their associated correlative studies and increasing regulatory oversight. The CTO provides centralized management to bring the necessary expertise into progressively more specialized areas of clinical investigation. Over the last 12 years, clinical research at the OSUCCC has evolved into a centralized shared resource providing complete protocol support across the cancer center. A summary of the resources provided by the CTO include: 1) protocol development; 2) regulatory administration and management; 3) trial activation and coordination; 4) financial and contract management; 5) data management; and 6) protocol tracking and monitoring.
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- To assist CCC researchers in translating scientific discoveries into therapeutic clinical trials.
- To assist in the submission and navigation of clinical trials through the OSU and Comprehensive Cancer Center Review committees.
- To develop clinical budgets and contract language for clinical trial agreements as per Ohio State University Research Foundation (OSURF) requirements and provide financial management of clinical trials to ensure appropriate and compliant third party payer billing.
- To screen, consent and enroll subjects to clinical trials as per the CTO policies.
- To provide centralized subject registration and tracking of subjects enrolled on to clinical trials into the CTO Clinical Trial Management Systems (CTMS) to include subject demographics, treatment arm assignment, toxicity and response information, trial status and serious adverse events.
- To ensure quality control functions by providing training and oversight of the conduct of clinical trial activities in accordance with local, state, and federal and institutional regulations.
To further compliment this structure, the James Cancer Hospital and the Comprehensive Cancer introduced the concept of Disease Specific Committees to facilitate the aligning of cancer care and clinical research. This new model facilitates the alignment of leaders within a cancer disease specialty and enhances the development and conduct of trials by multi-disciplinary teams. The overall role of the Disease Leaders is to:
- Design quality clinical trials that will be activated and completed quickly
- Monitor the progress of existing trials
- Encourage multidisciplinary interaction
- Mentor junior faculty
- Assess trial accrual potential and potential overlap between competing trials
- Assist in the identification and allocation of resources for conducting clinical trials
The CTO consists of a central office with a Medical Director, Administrative Director, Clinical Research Team Managers, Clinical Research Specialist-research nurses, (CRS), Clinical Research Coordinators (CRCs), Regulatory Compliance Officers (RCO), Clinical Research Data Coordinators (CRDC), Protocol Implementation staff, Data Managers and Administrative Staff.
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Clinical Research Team Managers
The Clinical Research Team Managers recruited are leaders in their field, and brought extensive cancer and clinical research experience to their new positions as well as a thorough understanding of CTO operations. The Clinical Research Team Managers provide an essential layer of oversight and training for an increasingly large and complex clinical trials operation at the OSUCCC. They also serve as an important liaison with faculty disease team leaders in fulfilling the research mission of the OSUCCC disease specific research groups. The Clinical Research Team Managers responsibilities include:
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- Participating in the clinical trial portfolio management in conjunction with the faculty disease leader to reflect the research goals, patient resource management and CTO resource allocation of the group.
- Supervising and training of CTO coordinating staff to provide for the efficient and compliant conduct of clinical cancer research trials.
- Collaborating with the CTO auditor to monitor staff performance.
- Serving as a key liaison with James Cancer Hospital and OSU East clinic personnel.
- Assisting the CTO Medical Director and CTO Administrative Director in aligning and developing CTO resources to match with OSUCCC goals.
Contract and Budget Services
Once protocols have been approved by the Feasibility and Clinical Scientific Review Committee (CSRC), budget/contract negotiations for the trial begin. The Office of Contract Development and Coordination (OCDC) will perform an initial review of the contract to negotiate compensation for injury terms and review of the budget and protocol to determine standard-of-care versus research procedures so that this information can be included in the consent form. Once the consent form language regarding compensation for injury language and costs and payments has been identified for the consent form, the CTO regulatory staff will begin the completion of documents for submission to the IRB. The contract language is negotiated by the grant’s analyst who acts as the sponsor’s liaison with the OSU Research Foundation (OSURF). Once the final language has been agreed upon between the university and the sponsor, the OCDC will facilitate obtaining final approval and signatures to contracts working with the OSU Research Foundation (OSURF). Execution of documents is completed when final contact signatures and IRB approval are available.
Trial budgets are established by the budget analyst who handles all budget negotiations for the PI. The budget analyst works with the James Account Research Office (JARO) to determine research versus standard of care costs for all trials and establishes research accounts and billing numbers post contract execution.
The grant managers work with the CTO coordinators to determine completed research visits and procedures so that charges can be invoiced to sponsors. The grant manager will resolve any research billing inquiries and work with JARO to assure clinical trial billing compliance.
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A Regulatory Manager who oversees the day to day operations of the Regulatory Department that is staffed with Regulatory Compliance Officers (RCO). As trials receive approval from both the Feasibility Review and Clinical Scientific Review Committees, the assigned Regulatory Compliance Officer (RCO) begins the creation of the documents to be submitted to the IRB for review. The RCO works closely with the Principal Investigator to develop trial documents to be submitted and reviewed by either the OSU or Western Institutional Review Boards. They also work with the PI to submit Investigational New Drug Applications (IND) to the FDA when applicable. The RCO works with the sponsor to generate the required regulatory documents that are filed in the regulatory file and submitted to the sponsor for review and approval.
Once a trial has been approved by the IRB, the RCO works closely with the PI, CTO Implementation Team and coordinator to activate the trial. The RCO continues to monitor and maintain regulatory documents in compliance with institutional, state and federal guidelines. Trials are submitted at least annually to the IRB for continuing review. Any trials that require an amendment change are processed by RCO and are submitted to the appropriate IRB for review. Any Investigational New Drug Safety Reports are submitted to the appropriate IRB committee for review by the Regulatory Department as per the local IRB’s adverse event submission policy. The Regulatory Department assists with industry sponsored monitoring visits and auditing preparations for all trials.
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The CTO employs Clinical Research Specialists (CRS) who are licensed nurses who are spread across the disease teams and provide clinical support to the Clinical Research Coordinators (CRC) who are non licensed registered nurses. The coordinating staff report to the Clinical Research Disease Team Manager and are responsible for all aspects of subject trial management, from screening, enrollment, treatment and long term follow-up. The coordinating staff participates in the informed consent process, monitor toxicities, oversee treatment administration, and ensure that only eligible patients are enrolled onto protocols. The role of the coordinating staff includes the following:
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- Participating with the investigators in the design, writing, feasibility, and review of protocols and consent forms prior to regulatory submission.
- Screening of potential patients for protocols through scheduling and reviewing of pre-study tests and procedures.
- Confirming eligibility criteria of subjects by reviewing all pre-study testing and subjects’ medical history against the trial’s inclusion/exclusion criteria.
- Reinforcing the investigator’s consent form discussion and obtaining and documenting the written subject’s informed consent process.
- Registering patients into the CTO Clinical Trial Management System.
- Collaborating with investigators during protocol-defined treatment plans to ensure protocol adherence and correct application of dose modifications or hold of agent.
- Monitoring of the subject’s adverse events and providing accurate documentation in the medical records.
- Collaborating with the investigator in review of responses.
- Timely reporting of Serious Adverse Events to regulatory agencies as defined in the protocol.
- Collaborating with the data coordinators regarding data collection.
The Clinical Trials Office participates in Cooperative Group, ndustry sponsored, as well as Investigator-initiated trials, for which Data Coordinators of the CTO complete, collect and enter data via online databases or paper case report forms. Data collection requirements and deadlines are determined by the type of trial and the sponsors of the trials determine the format for submission of data. Training of staff is accomplished both by in-house staff and sponsor created training programs.
There are two Data Managers who oversee the collection of data for all research trials. They work closely with the PIs and Clinical Research Data Coordinators to manage work loads, special data requests, ensure timely submission of data to sponsors, and are responsible for the training of newly hired Clinical Research Data Coordinators. The Data Managers have significant data management experience with all trials. The Data Managers are responsible for assessing all data delinquency reports received from the cooperative groups to assure the timely submission of data. They review data to ensure accuracy. Since the data management needs for industry sponsored, CTEP sponsored, and cooperative group trials are vastly different, the data management responsibilities of the CTO are divided into two groups: Non-Cooperative Group versus Cooperative Group trials.
The Non-Cooperative Group Trial Data Manager provides oversight of data collected for Investigator Initiated, industry sponsored, Phase I U01 grant funded, and Phase II NO1 contract trials. The Data Manager assures that data needing reporting to the NCI occurs within the NCI specified and required intervals and assures that the accuracy of the transmitted data using the ACES or CDUS mechanisms occurs in a timely fashion. The Data Manager works with industry sponsors to assure timely completion of electronic and paper case reports. The Data Manager works with the investigators to provide summary data for analysis for the completion of abstracts and is responsible for the direct supervision of the Clinical Research Data Coordinators.
The Cooperative Group Trials Data Manager provides support to all Cooperative group trials, such as CALGB, RTOG, CTSU and other consortium trials. This individual works with the PI of the cooperative group grant to assure that data capture to cooperative group case report forms is accurate and is submitted in a timely manner. The cooperative group Data Manager holds bimonthly CALGB meetings with all staff working with CALGB trials to review CALGB updates, accruals and regulatory updates.
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Clinical Research Data Coordinators
The Clinical Research Data Coordinators (CRDC) are responsible for data management for patients enrolled onto clinical trials. They abstract data from the Ohio State University Medical Center Electronic Medical Record systems (EMR) and work closely with PI and investigators, and coordinators to ensure accurate and timely data entry onto both paper and electronic Case Report Forms (CRF). The data coordinators follow Good Clinical Practice Guidelines (GCP) when completing all research data forms. The timeliness of the data submissions is reviewed regularly by the two CTO Data Managers. The data coordinators utilize OnCore® which allows for real time monitoring of timeliness and completeness of data. The Data Managers review data submission dates and appropriately work with staff to ensure that the data are timely and accurate and to make any necessary changes due to workload disparity.
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Clinical Trial Informatics
Clinical Research Management System
In 2007, the OSUCCC supplemented the in house developed Cancer Research Information System (CRIS) with the commercial clinical trial management software (CTMS) OnCore® from Percipenz (Madison, WI). The OnCore® software is the most widely adopted CTMS among academic cancer centers across the United States. OnCore® is an enterprise system providing for protocol and subject life cycle management, subject safety management, study calendars, financials management, electronic data capture and data management, paperless committee functionality (CSRC, DSMC), study information portal and custom reporting. OSUCCC has aggressively implemented this software package and is now utilizing all components of this enterprise system. OSUCCC has also taken a very active role in the Onsemble Community of OnCore® users, an interactive group that shares information, best practices and helps guide the evolution of the software product. From its inception Percipenz has been actively collaborating with the caBIG initiative from NCI and at present has bronze compatibility designation from caBIG.
Functions available in the OnCore® application include:
- Patient registration, protocol registration
- Paperless protocol review for the Clinical Scientific Review Committee and Data Safety Monitoring Committee
- Regulatory review tracking, subject visit tracking, budget tracking, and sponsor invoicing
- Track staff workloads and disease team accrual trends
Ensuring that protocol and subject registration data is accurately obtained is critical to the administrative reporting requirements put forth by the OSUCCC. OnCore® offers standard CTMS case report form functionality, which is used by the CCC for investigator initiated trials. CTO staff has the ability to transmit trial data directly to the ACES database while maintaining local records for internal use. Principal investigators and bio-statisticians appreciate the ability to export their data into Microsoft Excel or SAS for analysis at any time. While OnCore® has proven to be a comprehensive solution; the CCC continues to work closely with PercipEnz to continue development.
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Web-Based Clinical Trial Access
The OSUCCC and the James provides informatics support, software development and expertise to support the conduct of cancer clinical research. The online system is accessible 24 hours/7 day per week and is utilized by all OSUCCC clinical investigators. The online system provides all current and active clinical trial listings by disease site, active protocol and consent form documents, clinical trial orders sets, and SOPs are available within the system. The CTO regulatory staff is responsible for posting the protocols and consent forms.
Customized reporting has been written for the various disease teams and programs (CALGB, U01, NO1 etc.) to allow leadership to track research progress. Electronic data transfer is now performed between OnCore® and then data is transferred to NCI CDUS and Theradex ACES data capture programs. Patient laboratory values from the OSU Medical Center electronic medical records (e-Results) are captured into OnCore® via the OSUMC HL7 feed and automatically populate the OnCore® electronic case report forms (eCRF). The home built CRIS application is still utilized for specialized reporting (e.g., International Trials), affiliate registrations, reporting solutions and quality assurance functions.
Ongoing development of our suite of software products includes the development of the Biorepository & Biospecimen Resource (BBR) informatics application (including caTissue), interfacing with the hospital billing applications for automated billing disambiguation (research vs. standard of care) and continued involvement in Onsemble Forum. The OSUMC is in the midst of a large scale adoption of the EPIC electronic medical record which will be termed Patient Linked Ambulatory (PLA). Interfaces between PLA and various CTMS software will continue along with the adoption of specialized functionality within PLA for patient screening and communication between researchers. We will continue to adopt and interface with caBIG components as they become available.
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