FAQs (Frequently Asked Questions)

What is RTRN and how does it operate?

RTRN stands for Research Centers in Minority Institutions (RCMI) Translational Research Network. RTRN or the Network represents a groundbreaking effort to integrate clinical, biomedical and behavioral researchers from RCMI institutions across the United States and Puerto Rico working together with providers and community leaders in novel geographic and ethnically diverse research partnerships aimed at improving patient outcomes identified as key national public health priorities.

RTRN is designed to facilitate multi- and inter-disciplinary translational research teams to create evidenced-based knowledge and techniques to diagnose, prevent, and treat those diseases that are Healthy People 2010's priorities for improving the nation's health. The Network encompasses a cluster system (a geographically diverse working group linked by cyber workspaces) which promotes intellectual exchange and generates inter- and multi-disciplinary research, thus translating research from phase to phase. In addition, as research is generated, the Network will support multi-site studies conducted at the RCMI Clinical Research Centers (CRC), thus promoting large scale translational research. All research activities are supported by the Administrative Core and RTRN Data Technology Coordinating Center (DTCC). RTRN will capitalize on existing and emerging technologies and strategies, develop coordinated systems through shared governance and standardized protocols, and ensure data security and privacy issues are well established prior to engaging in highly sensitive research activities (genetic studies, electronic health records).

A highly active educational system using synchronous and asynchronous collaboratory learning tools are available to researcher clusters. As research concepts are generated through the clusters and developed into draft proposals, they are submitted to the RTRN Protocol Review Committee (PRC) to obtain concept approval. This is the first step of the process flow. Once approval is obtained, a protocol is then generated by the cluster project investigators across sites. The protocols are then submitted to the PRC for final approval and then moved forward through the process flow for refining and study implementation.

In reviewing project protocols, the PRC assesses available clinical research resources and expertise, DTCC resources, potential biomedical ancillary studies, feasibility of multi-site implementation, community level assessments, potential cost implications and recommendations for required resources that may be needed for implementation. The PRC makes recommendations for collaborations and sites for the multi-site research. Once the project has been approved and registered with the RTRN, it will follow a typical clinical research project life-cycle. The DTCC will assist in the MOO development, creation of data collection forms and protocol design including creation of stop points, and content and timing of generation reports.

What is the role of the National Institutes of Health (NIH) in the RTRN project?

RTRN represents an NIH investment that leverages existing health disparities research at 18 minority institutions (RCMIs) united in the purpose of improving the nation's health for the underserved. RTRN is supported by a grant provided by the National Center for Research Resources, a part of the National Institutes of Health (NIH).

What is RCMI?

National Center for Research Resources’ (NCRR) Research Centers in Minority Institutions (RCMI) program enhances the research capacity and infrastructure at minority colleges and universities that offer doctorates in health sciences. Because many investigators at RCMI institutions study diseases that disproportionately affect minorities, the program serves the dual purpose of bringing more minority scientists into mainstream research and enhancing studies of minority health.

RCMI support is provided by the NCRR Division of Research Infrastructure. It provides funding to recruit established and promising researchers, acquire advanced instrumentation, modify laboratories for competitive research, fund core research facilities, and other research support.

Graduate institutions eligible to apply for the RCMI grants must award doctoral degrees in health-related fields and have a 50 percent or greater enrollment of students from minority communities underrepresented in the biomedical sciences. These communities include African Americans, Hispanics, American Indians, Alaska Natives, Native Hawaiians, and Pacific Islanders.

RTRN is the nexus for leveraging the existing resources of the Research Centers in Minority Institutions (RCMI) in a well-coordinated and integrated manner to result in programmatic and training activities that are much larger than its individual parts.

What is the goal of the RTRN?

The overarching goal of RTRN is to produce tangible health benefits for diverse minority populations across the country through a translational research network aimed at reducing health disparities. The Network design therefore was created to look at diseases and areas of health concerns that impact most minority and underserved communities— diseases such as cardiovascular disease and related diseases, neuroscience and mental health, metabolic diseases, cancer and HIV-AIDS. Researchers from each of the RCMI centers across the nation will have the opportunity to collaborate, transfer knowledge, and communicate with others conducting research in the same health area. Important to health disparities work are activities that engage community, provide education, and disseminate evidence-based findings. All research activities will be supported by the Data Technology Coordinating Center.

What service(s) does RTRN provide?

RTRN facilitates translational research through cluster activities, education and training, community engagement, protocol review, regulatory activities and data management and analysis to support more robust and sustained research activities.

What is the DTCC? How does it operate?

Because the science generated through the Network defines the technology needs, the Data Technology Coordinating Center (DTCC) encompasses a service oriented architecture that is scalable, flexible, and inclusive of supportive regulatory safety structures. The DTCC is charged with enhancing human performance strategies, and supporting the dissemination of research information to the RTRN community (including providers and provider networks). The DTCC has established a secure web-based coordinated clinical data management system for the collection, storage, and analysis of data from multiple clinical and translational research activities. This unique web portal has functionality that includes data capture and integration of many different forms of data (clinical, imaging, biomarkers, etc). These data are generated in large part through studies utilizing existing RCMI Core labs which are integrated into RTRN. The DTCC provides a user-friendly system for cataloging the recruitment and referral of participants for clinical studies; tool kits for data mining and data sharing; and a public portal to facilitate information dissemination to clinicians, researchers, the lay public, and health policy officials. Through this web portal, the DTCC supports sharing and dissemination of educational, research, and community resources, and ongoing Network accomplishments.

The DTCC develops and manages operational templates for 1) clinical/biomedical activities (including socio-cultural) providing a coordinated clinical data management system for data collection, storage, exchange, and analysis, and 2) a highly active educational system using synchronous and asynchronous collaboratory learning tools. The DTCC is grounded in solid research design, biostatistics, clinical ethics, regulatory knowledge and data management to provide coordinated data collection, management, and analytic support for each of the three major Network platforms—clinical, biomedical, and educational.

The DTCC provides a secure and user-friendly environment across the entire spectrum of RTRN researchers, thereby providing a single framework to foster the accelerated advancement of novel research to the bedside.

Why participate in the RTRN?

RTRN provides a critical element of the translation of research from clinical to the real world by enhancing partnerships with diverse community stakeholders, promoting practical trials and/or effectiveness studies, and redefining research goals and methods such as focusing on cost-utility and econometric analyses to better inform everyday practice decisions and truly translate emerging scientific advances to improved healthcare delivery. RTRN is the nexus for leveraging the existing resources of the RCMI in a well-coordinated and integrated manner to result in programmatic and training activities that are much larger than its individual parts.

The Network expands research opportunities for students, fellows, faculty and magnet investigators. Through collective participation in Network clusters between basic, clinical, and community-participatory researchers, Network members will increase the quantity and quality of their studies, improve institutional capacity for health disparities research, training and education, and bring tangible benefit in terms of new evidenced-based advances and improved health outcomes to their communities as well as to the nation.

RTRN has provided specific funds to support proposals for innovative “proof-of-concept" projects to foster interdisciplinary and inter-institutional collaborations and address complex questions that so far have been refractory to solution through conventional strategies. Researchers participating in the Network can become members of multiple clusters with access to shared educational, research, and community resources available through the DTCC's secure Web-based platforms.

Data generated from RTRN studies will be available to the broader healthcare community to enhance their understanding of disease processes and its relevance to their health. The Network will nurture its members in an unprecedented way, encouraging exciting new collaborative relationships that strive beyond traditional disciplinary limitations.

Describe the DTCC portal.

The DTCC portal is a secure web-based window that provides access to a coordinated clinical data management system for the collection, storage and analysis of data from multiple clinical research centers.  This unique web portal has functionality that includes data capture and integration of many different forms of data (clinical, imaging, genetics, etc).  It provides a user-friendly system for recruitment and referral of participants for clinical studies; tool kits for data mining and data sharing; and a public portal to facilitate information dissemination to clinicians, researchers, the lay public, and health policy officials.  The DTCC portal is designed to foster collaborations between basic, clinical and community and participatory researchers. 

The DTCC portal provides access to an electronic library that will be accessible to scientific and lay community as an avenue for data sharing. The portal will:

  • Help users identify numeric data computer readable formats;

  • Acquire RTRN data for the Network's collection, yet available to the public; and

  • Provide a common user-interface to the archived data.

Is the information processed at the DTCC secure?

RTRN, through the DTCC, provides a secure, sophisticated computerized network and infrastructure that has multiple forms of physical and electronic security including: multiple firewalls, real-time intrusion detection systems, and network based virus, vandal scanning, prevention systems, and multiple levels of physical access control.

Safety and privacy limitations, the individual project research team, and the Steering Committee determine the depth of RTRN project data available through this portal. The data available to the general scientific public and the RTRN investigators may have different levels. The RTRN scientific community may have additional access due to their research needs, contingent upon pre-specified privacy restrictions.

Safety of human subjects will be accorded the highest priority in RTRN research projects. In addition to the many layers of protection afforded to participants through adherence to NIH and federal guidelines, institutional review processes and approval requirements, and oversight by the investigators and research staff, the research subject advocate (RSA) for each RCMI CRC will be involved in RTRN studies.

A Data Safety and Monitoring Committee (DSMC) will be established for relevant trials to periodically review study results in relations to participant safety and to provide the study investigators, the RTRN Steering Committee, and NCRR program office with frequent updates on the progress of studies in the RTRN.

Where is the DTCC located?

The DTCC is located in the Mississippi e-Center at Jackson State University and has over 6,500 square feet of dedicated space with redundant high-speed internet connections and Network infrastructure.

Why was Jackson State University (JSU) selected as the DTCC site?

Jackson State University has experience in delivering technology-based solutions that can be leveraged to ensure success of the RTRN DTCC. Additionally, they have a Video Access Grid which can be used for distance training, a strong partnership with Duke Clinical Research Institute, a remote data capture system already in place, access to the biostatistical staff of JSU, and a service oriented architecture to implement the Network. Also, they are able to build upon the Jackson Heart Study HL 7 platform.

What is the RTRN Administrative Core?

Within the Network lies the Administrative Core, an administrative structure that ensures that the Network's objectives are achieved in a timely manner, scientific productivity is maximized, and Network resources are optimally utilized. The Administrative Core's key role is coordination, operation and evaluation of RTRN, including oversight and implementation of key activities such as procurement, finances, personnel, fiscal planning, budgeting, strategic planning, science direction and program planning, and data coordination. The Administrative Core, in conjunction with the DTCC, also provides the support and start-up of all translational research activities.

The Administrative Core functions in a cooperative arrangement with the NIH program office, to oversee the operations and evaluation of the Network.

What is a RTRN Translational Research Cluster System?

Central to the Network's ability to transition from laboratory research to clinical research and from clinical research to the community and public health practice (and vice versa) is the implementation of translational research clusters linking clinical, biomedical and behavioral researchers with providers and community leaders into novel geographic and ethnically diverse research partnerships aimed at improving patient outcomes identified as key national public health priorities by the National Institutes of Health. The Translational Research Cluster System is the "brain-trust" of the Network; the clusters generate new ideas for educational activities and research collaborations.

Translational Research Clusters is a system of collaborative research clusters embedded within cyber workspaces to promote intellectual exchange, generate innovative inter- and multi-disciplinary research, and facilitate the movement of scientific advances across the translational research spectrum. Research clusters overcome the limits of space and time by functioning primarily through cyber workspaces within the RTRN portal using online collaboratory technology (technology to support videoconferences (seminars, works in progress, meetings), project management tools (WebCT, Microsoft Share Point), posting activities, projects and concepts, and other research and educational activities to optimize multi/-interdisciplinary interactions within RTRN).

The TRC system consists of three types of clusters: health/disease, research methods and supportive. Health and disease cluster encompasses groups of researchers and community representatives (including providers and provider networks) interested in a particular health area. The second type of cluster is the research method. Research Method cluster focuses on specific research methods. Researchers with expertise in various disease areas participate in this cluster. The third type is the supportive cluster. Supportive clusters are designed to facilitate community engagement, training and education, dissemination, and collaboration through the translational research cluster system.

What is the Educational Platform?

Creating an educational component in conjunction with the DTCC allows for increased access to the various educational and training materials at each institution and provides each institution additional resources and flexibility for their students and scholars.

RTRN's educational platform is a component of the Network which allows the partnering institutions to combine and share resources to enhance the development of a new generation of scientists grounded in the principles of multidisciplinary research to address complex translational research challenges and ultimately improve health outcomes. The DTCC supports the educational portal that allows participants to develop skills and/or keep their skills current through improved access to both live training schedules within the network and archived training materials that are provided via other venues (Web casts, documents, publications, interactive web-based certification training etc). Multimedia technology based educational and training activities for the RTRN members is a primary focus of the RTRN DTCC educational portal. The portal provides on-line training services delivered in the form of written documents, slide presentations, archived or live video streams/web casts, study guides and videotapes. The portal also provides a listing of on-line courses available to staff and members.

Users of the portal (i.e. members from the clinical study teams of the various RCMI sites) are able to choose a course and view training materials associated with that course. One of the training courses available is how to use the DTCC portal itself – an animated presentation which walks a user through the various sections of the portal using screenshots and voice prompts.

What is CRECD?

The Clinical Research Education and Career Development (CRECD) and RCMI programs currently offer clinical research, education and training, and research opportunities to develop minority clinicians and researchers. Supporting the development and interest in multi-center clinical trials aimed at reducing health disparities across minority populations will provide yet another compelling and clinically relevant career development tract for minority as well as majority students.

The Clinical Research Education and Career Development (CRECD) in Minority Institutions program has enabled the minority institutions who also have RCMI funded CRCs to establish a Master of Science in Clinical Research or related program. A formal structured curriculum, consisting of introductory and advanced courses in biostatistics, epidemiology, study design, bioethics, laboratory and molecular methods, bioinformatics and biomedical computing, as well as sessions and workshops on the preparation of NIH grant applications, in whole or part, are offered to eligible, promising students.

The following RTRN institutions currently have CRECD programs: Drew University, University of Hawai'i, University of Puerto Rico, Morehouse School of Medicine, and Meharry Medical College.

What is the Community Engagement Cluster?

The RTRN Community Engagement Cluster provides generalized input and ensure appropriate community representation in research clusters, provide assistance to health disparities researchers with regard to patient recruitment, and pursue strategies to enhance community/academic collaborations and community-based research infrastructure. The Community Engagement Cluster is responsible for establishing active community representation in research clusters and providing technical assistance to RTRN research projects with regard to participant recruitment and dissemination of research findings and information.

This Community Engagement Cluster enhances the Network's ability to inform basic researchers of potential real-world applicability and effectively translate clinical research findings to community and public health practice by ensuring that the communities being served by RTRN are involved with the planning, implementation, and evaluation of the research and by assisting RTRN researchers to maximize their participant recruitment efforts. Additionally, the Community Engagement Cluster provides assistance to health disparities researchers working with minority communities to overcome traditional barriers in collaborative community participatory research.

Community engagement is a collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. The Community Engagement Cluster:

  1. Recognizes community as a unit of identity;

  2. Builds on strengths and resources within the community;

  3. Facilitates collaborative, equitable partnership in all phases of the research;

  4. Promotes co-learning and capacity building among all partners;

  5. Integrates and achieves a balance between research and action for the mutual benefit of all partners;

  6. Emphasizes local relevance of public health problems and ecological perspectives that recognize and attend to the multiple determinants of health and disease;

  7. Involves systems development through a cyclical and iterative process;

  8. Disseminates findings and knowledge gained to all partners and involves all partners in the dissemination process; and

  9. Involves a long-term process and commitment.

What is translational research?

The mission of translational research is to translate scientific discoveries across and within disciplines to provide a more complete understanding of complex disease mechanisms and clinical outcomes. Although traditional translational research focuses on the integration of activities from bench to bedside, the Network has expanded this definition to include community and public health practice as the endpoint.

The translational research cluster activities for generating translational research include the following:

  • Review current basic and clinical research activities and capacity

  • Identify active basic research projects that have the most relevant clinical implications

  • Identify active clinical research projects that have the most relevant community/public health implications

  • Develop a research agenda for the Network, including recommendations for potential translational projects

  • Develop project concept plans for potential translational research projects

  • Facilitate communication and interactions between basic scientists, clinical researchers, and community stakeholders

What technology is in place to support the RTRN goals?

A scalable and highly functional platform will support clinical research (HL7), while a stable high performance Internet2-based network will allow sharing of large amounts of biomedical research data (e.g. imaging/molecular modeling/genomic and proteomic data), accessing high-end instrumentation (e.g., microscopy), as well as inter-institutional educational activities (e.g., video access grid, sharepoint).

The DTCC uses HL7 specifications that enable the semantically interoperable exchange of research data. This allows two or more systems or components to exchange information (across different domains) and to predictably use the information that has been exchanged, integrating structure, meaning and context.

These new Internets-mediated research Collaboratories represent a powerful platform and a significant opportunity for implementing major NIH initiatives related to cross-disciplinary research and translational research. However, data from the National Science Foundation (NSF) funded Science of Collaboratory project indicates that the number and scope of Collaboratories within the United States that are dedicated to biomedical research is very limited compared to the magnitude of currently funded NIH research activity. A panel of experts convened by NCRR identified requisite conditions for the development of successful biomedical research Collaboratories. These conditions include the broad and systematic evaluation of new generation Collaboratories and related technologies, the assessment of the impact of Collaboratories on the organization of scientific activity, and the assessment of scientific productivity associated with Collaboratories.49 New generation Collaboratories constitute an efficient vehicle for providing access to high quality research resources and research expertise to the type of institutions (e.g., RCMI, RCMI affiliates and partners) and type of populations (e.g., women, socio-economically disadvantaged communities, underrepresented minorities). Participation of these diverse institutions and populations will increase research relevance and facilitate translation of research advances.

What is the technology collaboratory cluster?

The technology collaboratory cluster is a consortium of faculty and/or scientists that are interested in collaboratory technologies within the community. They are the individuals who will attend virtual meetings, and be actively engaged in creating and developing dynamic and innovative tools to enhance collaboration by utilizing this innovative technology. Technological advances have already led web postings to be done through videoconferencing, computer access grids, and Google site; technology collaboratory cluster will be focusing on strategies that move the network forward. The technology collaboratory cluster will work with the DTCC Collaboratory and Educational Technology working group –an operational workgroup comprised of DTCC staff concentrating on maintaining and ensuring that what already exists will be functional and in place.

Describe the RTRN Proof of Concept process.

The Network is designed to facilitate the conduct of multi-site studies and encourage innovative translational approaches to basic mechanisms, prevention, diagnosis, and treatment of diseases that disproportionately affect minority and underserved communities. As a Network support structure, the RTRN Data Technology Coordinating Center (DTCC) will establish a secure web-based coordinated clinical data management system for the collection, storage and analysis of data from multiple clinical and translational research activities. The "proof of concept" pilot project is designed to establish the Network's capacity to effectively conduct multi-site studies with uniform standards (HIPAA), good clinical practices, and to disseminate study results.

The DTCC will work with the proof-of-concept study team to create the study specific process, and associated forms, policies and procedures.

What is the Protocol Review Committee?

The Protocol Review Committee (PRC) is responsible for providing the RTRN with a thorough scientific, ethical, and operational assessment of study concept plans and research protocols. A subgroup of the PRC reviews Concept Plans. Review criteria includes: 1) Potential for improving health outcomes; 2) relevance to health disparities; 3) cultural appropriateness and relevance; and 4) potential for translation of findings. The PRC will identify clinical research resources and expertise, DTCC resources, potential biomedical ancillary studies, feasibility of multi-site approach, and assess community level involvement, potential cost implications and make recommendations for required resources that may be needed for implementation.

Protocol reviews will be conducted by the entire PRC because they are more detailed and involve evaluation of both the study design as well as the proposed operations. The PRC will ensure that study protocols are accurate, consistent, complete and, to the extent possible, standardized relative to other RTRN protocols. The PRC membership includes the RTRN PI and co-Pis, the DTCC program director and CRC program directors, and an NCRR program officer, a community member representative (the chair from the community working group) and one BRC representative from a non-CRC institution.

The PRC's responsibilities will include, but not be limited to, the following tasks:

  • Prioritizing areas of research focus;

  • Determining guidelines for protocol submission to the RTRN;

  • Reviewing and approving RTRN ancillary studies;

  • Identifying institutional and national resources aimed at potential collaboration; and

  • Reviewing all existing relevant clinical studies in participating CRCs for inclusion in RTRN.

What are “proof of concept” projects?

The proof-of-concept projects are to be designed to foster interdisciplinary and inter-institutional collaborations to address complex questions that so far have been refractory to solution through conventional strategies. Specifically, the Network has provided specific funds to support proposals for innovative proof-of-concept projects to advance interdisciplinary research in health disparities. This project is designed to promote the National Institute of Health (NIH) "Roadmap Initiative", specifically as part of the program "Research Teams of the Future".

What does community participation entail?

Community-wide risk reduction could be achieved through community interventions such as mass education campaigns, clinical service provision, and worksite health promotion.

The RC will build upon this body of research demonstrating that community-based interventions employing participatory methods can produce positive health outcomes, community empowerment, and sustainable interventions for improving the health of disadvantaged communities.

It is important to acknowledge and address barriers to participation in research by minority groups and understand that barriers encompass issues that include and go beyond the participant level.

How are the RTRN Translational Research Clusters and DTCC Operational Groups different?

Operational groups are teams of DTCC faculty and staff that provide technical support for RTRN activities, whereas clusters are groups of researchers and community representatives interacting in cyber workspaces with the goal to foster translational research activities and intellectual exchange.

Describe the Multi-site research component of the RTRN.

The RTRN Multi-Site Research Component is a collaborative research process by which multi-site projects are implemented with a common research design and standardized/validated procedures and tools.

Central to the Network is the development of innovative multi-site research studies directed toward improving heath outcomes that will be coordinated through and supported by the DTCC. As support structure for the RTRN multi-site studies, the RTRN Data Technology Coordinating Center (DTCC) will establish a secure web-based coordinated clinical data management system for the collection, storage, and analysis of data from multiple clinical and translational research activities.

Multi-site research designs can be implemented to enhance sample size and obtain a more representative sample in a shorter time than at a single site. This enhanced generalizability of data will facilitate the more rapid translation of research at a broader level. In addition, consortiums and multi-site trials are becoming more prominent as they allow institutions to capitalize on one another's expertise, structure, resources, and strengths.

The RTRN institutions will address the challenges in multi-site research through the design of the collaborative Network and by training investigators to conduct multi-site clinical research. In addition to new investigators, key staff members who will be engaged in the multi-site clinical research trials will also require training to ensure that' protocols and procedures are followed and that studies maintain a high level of quality.

Through the implementation of the Multi-Site Research Component, RTRN proposes to establish a network of RCMI clinical and biomedical research centers and a data technology coordinating center that will streamline the identification, planning, and implementation of multi-site research studies. The Network will facilitate inter-institution collaboration and communication, standardization of research protocols and data management activities, and webcast trainings for multi-site research staff in data safety and project implementation issues.

The proof-of-concept pilot project is designed to establish the Network's capacity to effectively conduct multi-site studies with uniform standards (HIPAA) and good clinical research practices.

How do clinical research projects become a part of the RTRN?

Clinical research projects can become a part of the RTRN through one of several ways:

  • Translational research clusters develop a concept plan and submit it to the Protocol Review Committee for approval for implementation through RTRN. Projects currently conducted at the RCMI CRCs can provide preliminary data for multi-site clinical or interdisciplinary research.

  • A sponsoring agency such as National Institutes of Health (NIH) may solicit applications via Funding Opportunity Announcements (FOAs) and fund projects that will be carried out in the RTRN.

  • Sponsoring agencies may request that studies or trials be conducted in the RTRN. RTRN will release calls for proposals proof-of-concept pilot projects and small projects to be implemented during Years 3-5 (funds are set aside and a call for proposal for both proof-of-concept pilot and small project awards will be disseminated within the research clusters and throughout RCMI institutions).

  • RTRN clusters may solicit potential multi-site projects from RCMI institutions' portfolio clinical research by junior and senior investigators independent of NCRR sponsored programs, i.e., R01s, etc. RTRN may invite mainstream multi-site Pis who are interested in expanding their studies to include minority populations through involvement of the RTRN.

What is the clinical research process?

  • Initiation

  • Review and approval

    The Protocol Review Committee (PRC) is responsible for providing RTRN with a thorough scientific, ethical, and operational assessment of study concept plans and research protocols. A subgroup of the PRC reviews Concept Plans. Review criteria includes: 1) potential for improving health outcomes; 2) relevance to health disparities; 3) cultural appropriateness and relevance; and 4) the translational component. Protocol reviews will be conducted by the entire PRC because they are more detailed and involve evaluation of both the study design as well as the proposed operations. The PRC will ensure that study protocols are accurate, consistent, complete and, to the extent possible, standardized relative to other RTRN protocols. In reviewing project protocols, the PRC will assess available clinical research resources and expertise, DTCC resources, potential biomedical ancillary studies, feasibility of multi-site implementation, community level assessments, potential cost implications and recommendations for required resources that may be needed for implementation. The PRC will also make recommendations for collaborations and sites for the multi-site research.

  • Study Design

    Once the project has been approved and registered with the RTRN, it will follow a typical clinical research project life-cycle. The DTCC will assist in the MOO development, creation of data collection forms and protocol design including creation of stop points, and content and timing of generation reports.

    The research team (investigators, nurse coordinators, research coordinators, research associate, and administrative staff) will develop the Protocol Design for the project. In parallel with the Protocol Design activities, the Manual of Operations (MOO) for the project will also be developed. While the Protocol Design describes the 'What' (i.e., what needs to be done during the project), the MOO will describe the 'How' (i.e., how the operations will be conducted during the project). It will contain detailed instructions for data collection and other study activities. During this phase custom 'Informed Consent' drafts will also be created. The MOO will be updated during the life-cycle of the project. Each research project will have its unique ethical requirements. These requirements will be identified during the Study Design Phase. These ethical requirements will be further reviewed by the research subject advocates and ultimately the institutional review boards. The RTRN regulatory specialist (RS) will coordinate, review, and monitor bioethical issues that are salient at each potential study site and population.

    The outcomes of the Study Design Phase are

    • Protocol Design

    • Manual of Operations

    • Institutional Review Board (IRB) drafts

    • Training sessions scheduled for the research staff

    • Investigation Meetings scheduled

    • Database Design and Setup including Case Report Form (CRF) design, layout of eCRF data entry screens, identification and setup of rules for data validation and derivation

  • Recruitment

    The patient recruitment phase pertains to the enrollment of patients into the clinical research project based on the criteria established in the protocol design. This process will be conducted in strict adherence to the operating guidelines specified in the MOO and also as per the ethical and patient privacy guidelines established for the project. The DTCC will work with the project team to develop clinical data forms and provide feedback to clinical sites regarding enrollment entry or exclusion. Periodic reports will be provided to sites and project recruitment subcommittees as needed for selected projects.

    Recruitment phase involves patient recruitment, patient screening and patient enrollment.

  • Data Collection and analysis

    As patients are enrolled into the program and undergo the various tests and procedures outlined in the protocol, the data will be captured electronically. This data will be transmitted to the DTCC for review and analysis by the biostatisticians and other members of the research staff. Data Collection and analysis process involves data collection, data review and data analysis.

  • Study results and publication and closeout

How will the DTCC handle copyright issues of these publications, since the Copyrights are often owned by the publishing company?

Copyrights of new materials will be owned by the DTCC or shared by the DTCC and partnering institutions if pre-negotiated prior to starting of study. Anything owned by a publishing company will not be stored by the DTCC unless approved by the publisher. If approval is not given, there will be a link to the publishing company.