# Presentation: 383710

## Building Clinical Infrastructure and          		  Expert Support  		Michael Steinberg, MD, FACR 	ULAAC Disparity ProjectCentinela/Freeman Health System

## Functional Specifications  Address Limitations	Budget 	Personnel  Availability Develop Job Titles and Descriptions 

## Developing Functional Specifications for Implementation of Clinical Trials  Generic for all Clinical Trials Implementation  Specific to Disparity  

## 			Specifications and Requirements  a.       Responsible for promoting and maintaining good communication with physicians and patients regarding clinical trials  b.       Prepare reports, documents, and other data required for departmental administration. c.       Participate in the Cancer Program’s ongoing Quality programs. d.       Responsible for and participates in the management of data collection, analysis, monitoring case management of protocol patients, recruitment or enrollment of human subjects, development of informed consents, preparation of adverse event experience reports, or audit; construction or monitoring of case report forms; oversee maintenance of drug records; education of other health care professionals, patients of family.e.       Recruitment and randomization of oncology patients.f.        Ensure accurate delivery of Research forms, radiation Therapy and Pathology required by National Groups.g.       Assist at audits required by National groups, presentation of materials.h.       Responsible for review of treatment charts for accuracy in the delivery and recording of treatments.i.         To inform the respective National Groups, National Cancer Institute, and Institutional Review Board of Deviations of adverse reactions of participating patients.j.         To prepare all protocols for Institutional Review Board approval.k.       To modify all patient consents in accordance with the law in the state of California and within the bounds of DFMH.l.         To maintain the protocols in an orderly fashion so they are easily and readily available to physicians.m.     Coordinate activities of Protocol patients at other research sites.n.       Educate patient and family of patient on study o.       Ensure accurate delivery of results of research to the Institutional Review Board on an ongoing basis. p.       Maintain and deliver all official forms with the Department of Health and Human Services for all physicians involved in existing research programs.q.       Maintain and deliver all required forms for the Protection of Human Subject.r.        Supply  pharmacy with appropriate protocols concerning non-commercial and commercial drugs.s.       Order investigational drugs as needed for protocol purposes.

## t.       Periodically review navigator function in successful accrual to clinical trials u.       Evaluation in determining the eligibility of patients to the research programs.v.       Interviewing and assisting each prospective patient – Adult and Geriatric.w.       Discuss program with prospective physicians concerning patient referral to Research Program.x.       Prepare reports, documents, and other data required for departmental administration. y.        Participate in the Cancer Program’s ongoing Quality programs. z.       Responsible for and participates in the management of data collection, analysis, monitoring case management of protocol patients, recruitment or enrollment of human subjects, development of informed consents, preparation of adverse event experience reports, or audit; construction or monitoring of case report forms; oversee maintenance of drug records; education of other health care professionals, patients of family.aa.       Recruitment and randomization of oncology patients.bb.         Ensure accurate delivery of Research forms, radiation Therapy and Pathology required by National Groups.cc.         Assist at audits required by National groups, presentation of materials.dd.       Responsible for review of treatment charts for accuracy in the delivery and recording of treatments.ee.         To inform the respective National Groups, National Cancer Institute, and Institutional Review Board of Deviations of adverse reactions of participating patients.ff.      Prepare culturally and linguistically appropriate educational materials gg.       To modify all patient consents in accordance with the law in the state of California.hh.       To maintain the protocols in an orderly fashion so they are easily and readily available to physiciansjji.       Coordinate activities of Protocol patients at other research sites.kk.       Educate patient and family of patient on study ll.        Ensure accurate delivery of results of research to the Institutional Review Board on an ongoing basis. mm.       Maintain and deliver all official forms with the Department of Health and Human Services for all physicians involved in existing research programs.nn.        Maintain and deliver all required forms for the Protection of Human Subject.oo.       Supply  pharmacy with appropriate protocols concerning non-commercial and commercial drugs.pp.       Order investigational drugs as needed for protocol purposes.qq.     Periodically review investigational drug logs and inventories with pharmacy staff to assure that appropriate documentation is maintained and that federal guidelines are being metrr.       Evaluation in determining the eligibility of patients to the research programs.ss.       Interviewing and assisting each prospective patient – Adult and Geriatric.tt.       Discuss program with prospective physicians concerning patient referral to Research Program.

## 	Develop Job Titles and Descriptions  	 	Clinical Research Coordinator 	 	Clinical Nurse Specialist 	 	Community Health Educator 

##   Clinical Research Coordinator Coordinates data management activities. Coordinates administration and outcome of clinical studies.   Assures administration of IRB regulations, departmental guidelines for the CDRP project.  Completing regulatory requirements for research approved by the project IRBTranscribing information from patient charts to a Case Report formAct as a "coordinator" helping to screen for patients in the Radiation Oncology serviceAssisting with informed consent, ordering tests, collecting data and producing reports of final data  

##  Clinical Nurse Specialist Serve as the primary contact person for patients enrolled in the ProjectResponsible for ongoing medical and social needs assessmentsAssist entering data into Project database. Serve as administrative liaison and coordinate services for Project 	enrollees.  Work with patients in clinical settings in the Project target 	community   Supervise of the Patient Navigators assigned to the patients enrolled in 	project.  Responsible for ongoing coordination of care, telephone follow-up, 	patient education, data collection, quality assurance, report 	preparation, and individual patient Care plan preparation.

##  Health Educator   Reviews  available education materials about clinical trails Develops appropriate new  materials for these subjects assuring cultural 	and linguistic integrity  Develops community physician education about the Project Develops patient education regarding clinical trials and the program in 	physician officesCoordinates Navigator activities and outreach in the communityCoordinates community outreach   

## Expert Support – Identifying Partners 	Rationale for Partner Selection   		Particular experience  		Resources 		Research know-how 

## Characteristics of  Partners  	 Partners Will Be Actively Involved In: (1) 	development and conduct of the clinical trials(2) 	assessment capability as to  the extent to which the Project reaches 	out effectively to target population persons3) 	preparing Project outcome products (4)   help with RO1 applications 

## Mutual Benefits to Partners (1) opportunity to collaborate in research findings(2) opportunities to develop competence to more effectively diminish 				disparity(3) mutual educational opportunities(4) opportunities to increase experience in the use telemedicine and 	teleconferencing technologies(5) increase accrual to existing national and partner institution clinical 	trials(6) partners  to  increase  tertiary referral(7) opportunity for partner to increase its interaction with the local community as it monitors and evaluates the process and  impact of the Project on patients, community-based practitioners and the partner 	institutions so as to develop policy and programmatic recommendations 	with regards to disparities in cancer treatment and access to clinical trials. 

## How Partners Will Contribute to Achieving Project Goals 	Serve as members of the Project’s Clinical Advisory Council 		Clinical  trials capability	Provide health services expertise that will enable more effective 			project-community linkages  	Facilitate Program monitoring and evaluation to develop pertinent 			policy 	recommendations  

## Community Expertise	 Faith based organizationsPublic health organizationsCommunity action groupsCommunity based patient support organizations and 		groupsCommunity organizers and leaders