InfoEd Update

1. InfoEd Update Angela R. Charboneau Wishon, J.D. Assistant Vice Chancellor for Regulatory Compliance CCTSI RKSC Core Director

2. Interwoven Process . 2007 InfoEd International, Inc.

3. Phases (Planning Purposes) • Phase I – Enterprise Module (Base Faculty Profiles) • Completed • Phase II – Human Subjects & Grants Modules • “Back Office” Completed • E-Submissions is ongoing • Phase III – Conflict of Interest • E-Submission Implemented • “Back Office” is ongoing • Phase IV – Environmental Safety • Targeted to start in Winter 2010 (various sections of ES as parallel phases) • Phase V – Clinical Trials (parallel for UC Denver) • Phase VI – Animal Care and Use Committee • Phase VII – Animal Facilities

4. Main Portal Page

5. HS – Submission

6. HS – Submission

7. HS – Opening a Protocol 2007 InfoEd International, Inc.

8. HS – Sample of Running Meeting 2007 InfoEd International, Inc.

9. Human Studies - Development InfoEd’s Human Subjects Development module provides researchers with an online portal for preparing, submitting and tracking their clinical studies and socio-behavioral surveys. • eForm protocols can be designed to respond interactively to researcher inputs. Study attributes that have regulatory or institutional implications can prompt questions or additional forms (e.g. Socio-behavioral study or clinical study? Conflict of interest? Populations include children? Radioisotope? etc.). • The system includes a dynamic informed consent builder that generates customized templates on-the-fly based on the nature of each study. • An intuitive trial design tool enables investigators to quickly build out the arms, visits and procedures that define a study, which once approved becomes an interactive roadmap for the study within InfoEd’s Clinical Trials module. • User-friendly interface with field level help, links to product manuals, and integrated email support.

10. Human Studies - Development • Upload supporting materials (e.g. science documents; investigator brochures; informed consents; etc.). • Application documents are watermarked with protocol status, board name, and date. • Upon submission records are automatically checked for completeness. Incomplete records are disallowed with missing items highlighted. • The module features an electronic routing and approval mechanism for departmental reviews, which then feeds the Human Subjects Management module. • InfoEd’s compliance workflow supports multiple board reviews of an individual submission, streamlining the submission and tracking process. • When used in conjunction with InfoEd’s other compliance modules for animal protocols and environmental safety plans, the system supports an interwoven cross-office workflow (e.g. a human study with a radioisotope can be routed to both the human studies board and the radiation safety committee simultaneously).

11. Human Studies - Development • Human Subjects captures the complete submission history of a protocol. The InfoEd protocol is in effect a file folder that contains an initial application and all subsequent submissions, with a complete communications history for each. • Protocol amendments and modifications can be conveniently cloned from the last submission so the researcher can focus solely on necessary changes, minimizing administrative burden. • eForms can track changes so reviewers can readily compare and contrast a new submission against the currently approved version of the protocol. • New protocols can be copied from existing records so researchers that focus on a narrow band of activity can leverage forms from previous efforts.

12. Human Studies - Management • InfoEd’s Human Subjects Management module provides comprehensive support for tracking protocol applications and organizing the operations of Human Ethics Boards. • The status of all protocols can be viewed at a glance via InfoEd’s Workflow Manager. • The Management module inherits all submission details from the Human Subjects Development record, eliminating redundant data entry (e.g. investigator; project titles; sponsor info; populations; drugs; devices; etc.). • With an integrated electronic workflow, intake coordinators no longer have to check forms for completeness or rekey information from documents, streamlining the processing of new submissions. • Every submission is a complete protocol application and serves as a running summary of what the protocol looks like today, eliminating the administrative hassle of tracking amendments and modifications as isolated details.

13. Human Studies - Management • Detailed board administration controls (e.g. support of multiple boards; board member appointments; reviewer assignment tracking; meeting management for recording notes, votes and determinations; etc.). • Post-approval, Human Subjects Management automates the monitoring of renewal dates. Deadlines are instantly computed based on start dates and advance reminder notifications can be automated. The renewal dates are available for easy system-wide tracking. • Automatically generates communications (e.g. agendas; minutes; office letters; renewal notifications; etc.) based on customer templates. • Official Board communications to researchers are linked to the relevant submissions. Any subsequent revision to the submission is in turn likewise linked, providing a comprehensive threaded communication history. • System includes integration with InfoEd’s Certification and Training utility, built into the GENIUS module. Track personnel development programs to ensure compliance with institutional training requirements.

14. Human Studies - Management • Adverse Event Reports are tracked as independent submission objects within the compliance modules, and can be batch associated to multiple protocols based on the event’s attributes (e.g. PI, drug, method, procedure, sponsor, etc.). • Human Subjects Management includes a compliance manager for tracking the details of current audits and reviewing the history of past audits. • Workflow security enables the organization to control who can create/edit/delete a record and on what occasions they are allowed to do so. • User activity is tracked at the system, record, and field level. Protocol change history is available on demand in support of 21-CFR-11 compliance.

15. CT – Study Design

16. CT – Track Study Personnel

17. CT – Study Budget

18. CT – Sample Form (Study Visits)

19. Clinical Trials InfoEd’s Clinical Trials module brings order to the complex world of human studies. The system combines comprehensive standalone functionality with built-in integration to InfoEd’s other software solutions so trials can be linked in meaningful ways to related protocols, grants or contracts, publications, and patents. With InfoEd institutions can phase out disjointed legacy applications and paper-based processes and replace them with a single browser-based application that facilitates collaboration between the research personnel that support all the various aspects of a trial. • Centralized trial database facilitates system consolidation, improved data integrity, and shared access. • Browser-based module provides a unifying online hub for collaborative trial management allowing individuals to contribute from either Macs or PCs from on and offsite. • Capture all trial information in a single study record (e.g. personnel; sponsor contacts; trial design; visit schedule; protocol approvals; financials; enrollment activity; etc.).

20. Clinical Trials • User-friendly interface with field level help, links to product manuals, and integrated email support. • Add any number of user-defined fields (e.g. pick lists; check boxes; radial buttons; text boxes; and numeric fields) to any page in the Clinical Trails module to accommodate unique institutional requirements. • Code all administrative details (e.g. sponsors; procedures; populations; methods; locations; centers; keywords; etc.) using normalized look-up tables for meaningful cross-study reporting. • Upload supporting documentation (e.g. investigator brochures; study protocols; case report forms; agreements; etc.). • InfoEd’s ad hoc Reporting Tool provides access to all fields in all records, enabling customizable views of the data on demand. The module can export data in SAS format, and is also ODBC compliant for data exports to 3rd party statistical analysis packages and institutional data warehouses.

21. Clinical Trials • Clinical Trials module leverages the InfoEd platform’s central contact management system. Communication history is maintained both centrally at the contact profile level, as well as discretely within each record. • Clinical Trials provides for links with other InfoEd modules, enabling tight coordination with other research offices on related grants, protocols, and agreements. • The status of all office records can be viewed at a glance via InfoEd’s Workflow Manager. • Workflow security enables the flexible division of administrative functions between distinct areas of operation (e.g. trial design; contract administration; participant management; etc.). • Access to trials is highly controlled. By default researchers only have access to those studies to which they are directly associated. Individuals with departmental or central management roles can be granted access to all trials in their area.

22. Clinical Trials • User activity is tracked at the system, record, and field level. Change history is available on demand. • Clinical Trials can capture the status and high-level details of all associated protocol reviews. The module is tightly integrated with the InfoEd Human Subject module, allowing changes in protocol status to seamlessly update linked studies. • Adverse Event Reports are tracked as independent submission objects within the Clinical Trials module, They can be batch associated to multiple protocols based on the event’s attributes (e.g. PI, drug, method, procedure, sponsor, etc.). • The system can track the status, terms and conditions, documents and communication history of every agreement related to a trial. • The system can track the inventory of study drugs within each trial. The trial design can account for use on a per visit basis. As clinicians record visits, the inventory counts are automatically decremented, which can in turn trigger alerts based on pre-defined minimums.

23. Clinical Trials • Flexible study binder for uploading important trial related documentation (e.g. investigator brochures, 1572s, consent forms, certifications, logs; etc.) facilitates regulatory compliance • Flexible study binder for uploading important trial related documentation (e.g. investigator brochures, 1572s, consent forms, certifications, logs; etc.) facilitates regulatory compliance • The module includes a Site Monitoring utility for tracking inspections and recording comments. • The module features an intuitive trial design tool, which allows investigators to quickly build out the arms, visits, procedures and cycles that define a study. The trial design serves as an interactive roadmap that drives participant and provider scheduling, as well as milestone billing. • Investigators can save and reuse trial templates to accelerate the design process.

24. Clinical Trials • Trial Design is a shared utility with InfoEd’s Human Subjects Development module. If the modules are used in conjunction with each other, trial design details can flow from the study’s protocol to the linked trial. • Procedures are stored in a normalized table controlled by the customer based on internal or industry standard codes. The procedure table is part of a sophisticated charge master that supports complex menu based pricing by charge class and performance site. • Within a trial, each selected procedure can be flagged independently as either a research procedure or standard-of-care to facilitate proper billing. The procedures can then be separately classified for recovery source (e.g. sponsor; internal account; participant; etc.). • The trial design utility rationalizes trial budgeting across all studies. The system provides valuable insights on trial costs and breakeven points that support effective negotiations. • InfoEd supports a variety of approaches to managing Case Report Forms from simply indicating a paper-based form or 3rd party CRF system, to storing and distributing CRFs as electronic documents, to developing electronic CRFs within InfoEd.

25. Clinical Trials • Organizations can flexibly design and maintain 100% electronic Case Report Forms (eCRFs) using InfoEd’s eForm technology. Investigators can develop unique eCRFs or leverage libraries of stored fields, sections, and complete forms available for re-use. • InfoEd’s Auto-Fill utility can conveniently load standard personnel and organizational details into new eForms upon creation, reducing effort and improving data quality. • eCRFs can be designed to respond interactively to clinician inputs. Details such as participant lifestyle, pre-existing conditions, or reactions to study drugs that might have medical or trial implications can prompt supplemental questions or additional forms. This dynamic quality also makes the eForms well suited for screening questionnaires. • The trial calendar is interactive. Each visit has drill down detail so clinicians need only open an appointment and follow the procedures dictated by the related trial design. • Trial calendars are automatically filtered based on security permissions. Coordinators and clinicians can further filter their calendar by any select study or participant. In addition, the calendar can be viewed by day, week, or month. All calendar views are printable.

26. Clinical Trials • Clinicians can reschedule any individual participant’s appointments to allow for missed visits or conflicts. • Clinicians can record any unplanned treatments performed during the course of a visit. Such procedures are automatically categorized as off-protocol procedures for record keeping purposes. • Trial design establishes a program for event driven billing. As studies are activated, protocols are approved, patients enrolled, and procedures delivered, charges can be automatically generated against the appropriate accounts. • The module can generate invoices and age receivables. Checks received can be distributed against existing receivables across multiple studies. • Completed budgets can be shared with InfoEd’s Proposal Development module to support any associated grant applications. • InfoEd is continually expanding integration support with evolving industry standards such as HL7 and CaBIG.

27. Electronic Research Administration ERA Access: https://era.cu.edu COMIRB Page: http://ucdenver.edu/ACADEMICS/RESEARCH/ABOUTUS/COMIRB/GETTING-STARTED/Pages/electronic-research-manager.aspx