UPMC Clinical Protocol and Data Management Research Services

CPDM facilitates the following:

1. Assistance to the Principal Investigator (PI) in the development of clinical research studies:
   • Provides guidelines and format requirements for clinical research studies.
   • Serves as the central intake and distribution point for all cancer-related clinical research studies (NCI sponsored, investigator-initiated, pharmaceutical/biotech, and cooperative group), and ensures that all components of each study are completed prior to protocol activation.
   • Facilitates document preparation for submission to all governing bodies, in accordance with the Office for Human Research Protection (OHRP), Food and Drug Administration (FDA), and University of Pittsburgh IRB or other designated, accredited, central IRB.
   • Maintains a master regulatory file for each clinical research study that includes all communications, amendments, Serious Adverse Events (SAE) reports, and notices sent for activation, suspension, closure, and termination, as well as other relevant study correspondence.
2. Preparation of research studies for presentation at Hillman’s Protocol Review Committee/Protocol Review and Monitoring System (PRC/PRMS)
   • Ensures the review of the protocol by the Disease Center Medical Director and assists the PI in identifying the CPDM resources to be utilized and funding available for the newly proposed study. The review must occur prior to submission of the study to the PRC/PRMS. The PRC/PRMS utilizes a standardized checklist that provides pertinent information for the PRC/PRMS reviewers. The checklist must accompany the study and lists all resources that would be utilized, as well as documentation that the Disease Center Medical Director is aware of and approves the use of the resource.
   • Maintains documentation throughout the entire PRC/PRMS process, and assists with response to PRC/PRMS questions and comments.
   • Prepares PRC/PRMS-approved studies for submission to the appropriate IRB(s).
3. Preparation of research studies for the University Institutional Review Boards (IRBs)
   • Maintains a database containing information on all research trials including investigator-initiated, peer-review funded and cooperative group, and pharmaceutical/biotech-sponsored clinical research protocols. The database identifies where each study is in the approval process.
   • Provides timely submission of the study and all supporting documents to the appropriate IRB(s).
   • Amends all clinical research studies in a timely manner and submits to the IRB(s).
   • Informs investigators of the approval status of each clinical research study along with a report of the progress of all ongoing research trials.
   • Prepares study renewal forms and study progress reports for review by the appropriate IRB(s) in compliance with their guidelines.
   • Submits ongoing correspondence regarding the study status (i.e., study closure, suspension, and closed to accruals).
   • Submits all Data Safety Monitoring information received from sponsors on multicenter trials and from the Hillman DSMC to the IRB.
   • Submits all Serious Adverse Events (SAE) reports to the University IRB as per their guidelines. Updates consent forms based on new risks identified or changes in the frequency of risks.
   • Prepares monthly reports on study progress including adverse events, protocol deviations, and death while on study for the DSMC.
   • Facilitates communications between the IRB Executive Committee and the Hillman investigators by meeting regularly with the IRB Chairman, Director, and staff to review processes and problems in order to ensure rapid and effective resolution so as to maintain compliance of the federal regulations.
4. Preparation of research studies for the FDA, including investigator-held IND submissions; NCI/CTEP; and/or other research sponsors
5. Designation of Disease Center team members
   • A Clinical Research Manager (CRM) is responsible for day-to-day operations of a given Center, which includes oversight of research staff, ongoing clinical trials, and activities associated with activation of new clinical trials.
   • Clinical Research Coordinators (CRCs) are responsible for caring for research participants during screening and while on trial; ensuring protocol requirements are met; identifying the clinical requirements for new trials; assisting with biospecimen collection, processing, and submission; and developing study-specific source documents (data collection forms).
   • Regulatory Specialists are responsible for identifying the regulatory requirements of new trials and obtaining and maintaining all required regulatory approvals.
   • Clinical Research Associates (CRAs) are dedicated to specific trials and are responsible for timely data entry into case report forms (CRFs) based on completed data collection forms and other source documents obtained from the subject’s medical record; assisting with identification of the clinical and data management aspects of new trials; and assisting with biospecimen collection, processing, and submission.
6. Implementation of newly opened clinical research studies
   • The clinical team collaborates with a multitude of disciplines and support facilities in order to ensure effective implementation of each study. CRCs are responsible for facilitating and enabling communication among all departments, and for maintaining current clinical research and patient information on a daily basis. CRAs are assigned to assist the CRCs with data collection, data entry, and quality control.
   • The CPDM quality assurance/quality control (QA/QC), Education, and Compliance Department conducts routine monitoring of all CPDM-facilitated trials and is responsible for coordinating all CPDM activities related to internal and external audits. This includes complying with the auditing requirements of cooperative groups/NCTN, Theradex (on behalf of the NCI), FDA, and IRB, and responding expeditiously to any deficiencies identified during auditing. Official audit findings and reports are used by the Department as a tool to re-educate CPDM staff on appropriate clinical research practices.
   • The University of Pittsburgh Education and Compliance Office (ECO) monitors, at regular intervals, the research and regulatory files of investigator-initiated trials for which UPMC Hillman Cancer Center holds the IND application. The ECO provides CPDM with a formal report of its results following each monitoring visit. As required, the assigned Disease Center CRM works with the ECO team to resolve any outstanding inquiries in a timely manner.
7. Facilitation of budgets and contracts
8. Monitoring of accrual of subjects for clinical research studies, and regular distribution of reports on accruals
9. Facilitation of patient screening, registration to trials, and monitoring throughout treatment process
10. Coordination of clinical research studies at all UPMC Hillman Cancer Center sites in regard to safety, regulatory compliance, and other requirements for study implementation
11. Documentation/reporting of adverse reactions (serious and non-serious) to all appropriate regulatory committees, (e.g., IRB, FDA, NIH, OBA, NCI, UPMC DSMC, etc.)
12. Audit of trials and coordination of sponsor site visits with implementation of any corrective measures
13. Collection and entry of data entry into the Clinical Trials Management Application (CTMA) or sponsor-designated electronic data capture system