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Collaborations
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At PercipEnz, we believe that the people who use OnCore every day are the best resource for understanding the workflows and processes supported by OnCore. Therefore, all major development projects for OnCore are conducted in collaboration with key research institutions and individuals. These people contribute real-world operational knowledge and experience throughout the project. Past initiatives have resulted in the ePRMS module for paperless committee management and the OnCore system for biospecimen management. The Onsemble community is comprised of people who are committed to excellence in cancer clinical research. Often, people in the community will form Special Interest Groups (SIGs) as a formal way to explore improvements to clinical research operations or to leverage eachother’s expertise. PercipEnz hosts these SIGs providing such things as a facilitator, webinar and teleconferencing resources, a meeting calendar, ListServ, and a document repository. The current active collaborative initiatives and SIGs within the OnCore community are listed below. To submit information on any of these initiatives or if you have any questions regarding them, please send an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (608) 826-6000. CollaborationsOnCore Product Enhancement Focus Groups OnCore caBIG Collaborations | Compliance Collaborative Initiative | OnCore Software Development Toolkit (SDK) Collaborative Initiative | OnCore Protocol Submission Collaborative Initiative | OnCore Multi-Center Trial Support Collaborative Initiative | OnCore Working Group | Biospecimen Management Collaborative Initiative | Onsemble Metrics Collaborative Initiative “Metrics & Beyond” | Registries Special Interest Groups (SIGs)Biostatistics SIG | OnCore Financials SIG | Standard Operating Procedure (SOP) SIG Request an Onsemble.net Account |
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OnCore Product Enhancement Focus Groups
MissionMultiple "Product Enhancement Focus Groups" are being established to provide community inputs into the OnCore product enhancement process. These focus groups will be asked to submit and prioritize enhancement ideas for the specified OnCore functional area. The agreed upon enhancements will be implemented in an upcoming release. Biostatistics Special Interest Group
Launched: October, 2009 Mission
This special interest group was formed with the following objectives:
To start, there was an online workshop on October 14th, 2009. During this workshop, Tony O'Hare, Chief Scientific Officer at PercipEnz provided some background into technology available for study data extraction from OnCore. Following this, Tim Breen, PhD, MS, CCDM, Biostatistics Project Coordinator at Indiana University Simon Cancer Center and Michael Chiu, Biostatistician at UNC Lineberger Comprehensive Cancer Center shared their expertise and some of their successful strategies and techniques with the group. PowerPoint presentations from this workshop are now available in the document resources for this group. AttendeesAll OnCore centers are encouraged to participate. Biostatisticians will find this group most helpful. Standard Operating Procedure (SOP) SIG
Launched: February 2009 MissionThe Standard Operating Procedure SIG was created with the charter to create an online SOP library that all centers can utilize. Initially, the group will focus on five primary categories of SOPs: (1) Clinical, (2) Regulatory, (3) Quality Assurance, (4) Protocol Writing, and (5) Finance. To start, all Onsemble cancer centers are encouraged to share sample SOPs from their centers. The ultimate goal of this initiative is to create a library of SOPs based on agreed-upon best practices and interpretations of requirements. To create initial drafts of these SOPs, participants divide into groups of 2 to 4 people. Then, the larger group reviews and comments on these drafts. Final SOPs are then posted in the Documents section of the Onsemble.net website. Annually, these SOPs will be reviewed and updated. AttendeesAll OnCore Centers are encouraged to participate. People with the responsibility of creating SOPs at their institution will find this especially valuable. Participating Centers
Onsemble Metrics Collaborative Initiative “Metrics & Beyond”
Launched: April 2009 MissionObservations at Onsemble institutions indicated the need for a concerted effort to understand the magnitude of difficulties encountered regarding protocol performance, protocol implementation and research staffing metrics. Twice yearly Onsemble workshops addressed these issues. A poster based on the work done in this group will be presented at the ASCO meeting in May, 2009. Significant progress was made in three areas:
The Onsemble Metrics Collaborative Initiative was launched to build on these successes and provide a more formal framework to accomplish the work that is done in this area. AttendeesAll OnCore Centers are encouraged to participate. People on the leadership teams in the clinical trials office at their institution will find this especially valuable. Protocol Submission Collaborative Initiative
Expanded and Re-Launched: March 2009 MissionThe goal of this collaborative initiative is to get all OnCore centers connected to Crescendo services so they can share and transmit select protocol information as needed. Initially projects will include providing seamless integration with the NCI Clinical Trials Reporting Program (CTRP) and the ability to list investigator initiated trials in the Crescendo IIT Search database. This initiative will leverage the work that was done previously resulting in registering new trials and maintaining automatic status updates for existing trials with the NCI’s Physicians Data Query (PDQ®) registry and, via PDQ, with the ClinicalTrials.gov registry. Future objectives of this initiative will include automated or streamlined registration with other registries such as ClinicalTrials.gov. AttendeesAll OnCore Centers are encouraged to participate in this collaborative initiative. Regular attendance in this meeting will be most beneficial to members of the clinical trials office leadership team as well as OnCore coordinators. Participating Centers
OnCore Software Development Toolkit (SDK) Collaborative Initiative
Launched: March 2009 MissionDuring the ODEAN (OnCore DEveloper and Adopter Network) workshop that was part of the Spring 2009 Onsemble conference in Stanford, California, participants shared business cases for using and extending the existing framework for programmatic access to OnCore. As a result of the interest generated by this workshop, PercipEnz launched this collaborative initiative to guide the further development of the OnCore Software Development Toolkit (SDK). The goal of this effort is to develop and deploy interfaces and other mechanisms designed to allow ODEAN members to more easily connect OnCore with other software applications and information systems. Although there will likely be opportunities for each center to pilot such interfaces as part of specific projects, the intent is to create an SDK that is of general utility rather than serving the specific needs of one institution. To that end, the participants in this initiative will help to identify, define, and deploy mechanisms that will help them and their colleagues to interface with OnCore in the context of other projects and activities such as: (1) Integrating with local systems, (2) Creating and sharing custom reports, (3) Creating and customizing intranets and portals, (4) Developing special applications and tools, (5) Supporting and maintaining systems, and (6) Piloting new technologies AttendeesTechnically oriented software developers and database administrators with an interest in leveraging OnCore within the local context of their institution. These people are typically already members of the OnCore DEveloper and Adopter Network (ODEAN). Participating Centers
OnCore Multi-Center Trial Support Collaborative Initiative
Launched: November 2008 MissionAs more and more OnCore centers engage in multi-center studies, there is an unprecedented opportunity to enable them to share study data electronically. The goal of this collaborative initiative is to make mounting a multi-center clinical trial as easy as mounting a local study. This is done by leveraging the frictionless plane offered by inter-connecting OnCore systems to create and refine open data exchange standards. Ultimately, these standards can be used by any center with any system, not just OnCore centers. OnCore already supports affiliate networks by providing controlled, web-based access over the Internet. Users at an affiliate site merely log onto OnCore and proceed to enter data according to the policies set by the cancer center. For example, some centers allow affiliates to register subjects to a study while others only allow them to enter the registration data which is then reviewed by cancer center personnel who then complete the registration process. Over the last few years, this support has been proven to be effective and efficient for affiliate sites. The new challenge is to connect these cancer centers with affiliate networks together into a network of networks. Working with the original five cancer centers (all of which are using OnCore) that comprise the South East Phase II Consortium (SEP2C), we are piloting capabilities for each center to enter data into their local OnCore instances and then exchange that data electronically with other consortium members, as needed. AttendeesInitial collaborators include representatives from the South Eastern Phase II Consortium who are piloting the OnCore Multi-Center Support functionality. Participating Centers
OnCore Financials SIG
MissionTo create an understanding of the complex requirements of clinical research informatics in regards to financials. Participants discuss issues and concerns regarding billing compliance, budgeting, invoicing, receipt reconciliation, payables and financial deviations caused by expected and unexpected events along with financial reporting needs. Participants also share information about their processes and their relationships with sponsors, hospital billing, and other entities both within and outside of their organization. AttendeesParticipation in this SIG is open to all OnCore centers. Participation will be most valuable to people who are knowledgeable for the financials management Participating Centers
Compliance Collaborative Initiative
MissionA collaboration with select cancer centers to enhance the auditing capabilities and functionality of OnCore. The goal is to develop functionality to support all aspects of the auditing process from the initial selection of subjects and data elements to be audited to presenting this information to the auditors and capturing the auditor's responses. Future areas of this collaboration will include auditing with respect to subject case report forms, regulatory, and pharmacy information. Participating Centers
Biospecimen Management Collaborative Initiative
MissionTo develop a biospecimen management system that is integrated with OnCore. This system supports all aspects of the general biospecimen management process including collection, processing, annotation, storage, distribution, and the associated quality assurance mechanisms. This successful collaborative initiative resulted in the OnCore-BSM system which becaue generally available in 2007. Participating centers continue to meet regularly to provide operational feedback and to help guide the continuing evolution of the system. AttendeesAll OnCore Centers that currently use the OnCore-BSM system, or are implementing the technology, are encouraged to participate. People who will benefit from regular attendance include biorepository resource directors, managers and coordinators, OnCore coordinators, and laboratory technicians. Participating Centers
OnCore Working Group
MissionThe OnCore Working Group is a forum to discuss issues that affect the majority of the OnCore centers. Discussions will include such topics as: enhancements to OnCore functionality, training resources, OnCore release schedules, regulatory issues, reporting requirements, operational issues, and conference updates. AttendeesPeople who will benefit from attending these meetings include members of the leadership teams of their center’s clinical trials office. This includes clinical trials office directors and managers. OnCore Coordinators will also benefit from regular attendance in these monthly meetings. Others are invited to attend as needed based on the relevance of specific agenda topics. Participating CentersAll OnCore Centers
OnCore caBIG Collaborations
MissionAs part of their commitment to facilitating collaborative clinical and translation research, PercipEnz is providing resources to assist OnCore centers who are participating in the Getting Connected with caBIG program. This assistance includes liaisons at PercipEnz who are knowledgeable about caBIG technology and integrating caBIG and Oncore technologies. The liaisons will also facilitate communications and information sharing with a goal of leveraging the combined efforts of the participating centers. AttendeesThis initiative serves caBIG Deployment Leads primarily. Participating Centers
Unified Registries Management
Launched: April 2009 MissionThis collaboration is working to define a single information system capable of supporting multiple registries, which in part may be built using data from previously created registries. Although the registry system will permit the creation of isoloated registries that do not share data, several aspects fo the design are intended to promote data sharing. The most fundamental of these is the support for standardized common data elements that can be selected from a local library. Another important component of the registry system will be the ability to create a de-identified version of a registry. AttendeesThe OnCore centers that are participating in early pilots of the new system. Participating Centers
Biospecimen Management Workshop
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