PercipEnz, the OnCore People

Collaborations & Special Interest Groups

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 OnCore community is comprised of people who are committed to excellence in clinical and translational 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 each other'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.

OnCore caBIG Collaborations

Primary Purpose: As 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.

Participating Centers: This initiative serves caBIG Deployment Leads primarily.

Compliance Collaborative Initiative

Primary Purpose: A 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.

OnCore Financials SIG

Primary Purpose: To 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.

Participating Centers: Participation in this SIG is open to all OnCore centers. Participation will be most valuable to people who are knowledgeable for the financials management

OnCore Software Development Toolkit (SDK) Collaborative Initiative

Launched: March 2009

Primary Purpose: During 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

Participating Centers: Technically 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).

OnCore Protocol Submission Collaborative Initiative

Expanded and Re-launched: March 2009

Primary Purpose: The 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.

Participating Centers: All 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.

OnCore Working Group

Primary Purpose: The 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.

Participating Centers: People 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.

Biospecimen Management Collaborative Initiative

Primary Purpose: To 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.

Participating Centers: All 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.

Standard Operating Procedure (SOP) SIG

Launched: February 2009

Primary Purpose: The 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.

Participating Centers: All OnCore Centers are encouraged to participate. People with the responsibility of creating SOPs at their institution will find this especially valuable.

Onsemble Metrics Collaborative Initiative "Metrics & Beyond"

Launched: April 2009

Primary Purpose: Observations 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:

  1. Observations regarding protocol performance. This has resulted in the establishment of methods to measure the impact of initiatives. The effectiveness of protocol selection rules have been measured and proven to improve protocol performance.
  2. Protocol implementation metrics. This has resulted in the establishment of protocol implementation benchmarks and score cards to allow centers to compare their performance against the Onsemble community and to pinpoint areas in need of improvement and/or further investigation.
  3. Regulatory staff effort. This has resulted in the ability to estimate regulatory capacity with more precision than previously known.

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.

Participating Centers: All OnCore Centers are encouraged to participate. People on the leadership teams in the clinical trials office at their institution will find this especially valuable.

Registries

Launched: April 2009

Primary Purpose: This 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 of 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.

Participating Centers: The five centers that will be piloting this technology.