Research Information Technology

Clinical Research Current IRB Operations Potential IRB Improvements using the CCRC Basic Research Medical Informatics Research

Clinical Research

Clinical research is a complex, highly regulated, data intensive activity. Technology has much to offer:

• Management
  • IRB library of background documents and forms
  • IRB submissions and tracking
• Patient Enrollment
  • Identification of candidates by IRB approved alerts in the EMR
  • Presentation of appropriate consent documents and validation of requirements
• Data management
  • Collection of required data through reminders and data entry screen
  • Extraction of de-identified data for analysis
• Clinical Trials Center
  • Managing patient registries
  • Biostatistical and informatics support of trial design and oversight
  • Enhancing CMH's role as the center controlling multi-institutional clinical trials

Current IRB Operations

The IRB Policy and Procedures Manual components and the relevant subsections (IRB submission packet, consent/assent document templates, HIPAA related waiver request/approval/accounting for disclosure forms) are available electronically. In the last 9 IRB sessions, the documents have been returned in electronic form and distributed on CD-ROMs to the IRB reviewers. Approximately 80-90 documents per meeting are now managed by a single staff person and the IRB Chair. Cooperation from investigators in conforming to the electronic requirements has been excellent.

An increasing number of investigators/research assistants are also submitting required annual (progress) reports, adverse events, and minimal risk protocols (expedited review) electronically (via e-mail with documents attached). This permits rapid review (almost always within 24 hours) and response to the investigator and copies to IRB staff. Print outs of the correspondence are still required for the official IRB paper protocol files and the official approval documents, including the IRB date stamped consent/assent forms sent to the investigator.

Potential IRB Improvements using the CCRC

The Children’s Computing Resource Center (CCRC) could provide online support for the IRB and clinical investigators.

1. Web based intra- and inter-net sites for IRB management and submissions. Several systems at other institutions are being tested. NU’s IRB is currently considering several options. Customizing various commercially available packages or internally developing systems have been done at other institutions. CMH/CMIER (via Phil Spina) has previously expressed interest in a system geared to smaller academic institutions (vs. the mega institution such as NU).
2. Automated identification of potential research subjects. After IRB approval, it would be desireable to have templated CCRC tools which are completed by the PI and registered with the CCRC. These templates would permit extraction of data from the EMR and the accrual of patients into the clinical research project.
3. Automated tracking of consented research subjects.
4. Patient Registries. There are currently an estimated 14 IRB databases at our institution with approved HIPAA waivers. Most are for institutional (divisional) databases, but a few involve data from/to other institutions.
5. Remote Data Entry (RDE). RDE systems would permit CMH to be in the driver's seat in managing multi-institutional clinical trials. It would also facilitate participation in trials run out of other institutions. The Children’s Oncology Group, ACTG, and the COG Pathology Center headquartered at CMH (under Dr. Elizabeth Perlman) are examples that could be emulated in an expanded RDE facility.
6. Core Personnel. Managing clinical trials requires a cadré of technology support personnel, biostatisticians, informaticians, and monitors. These are more readily developed in a core facility such as the CCRC with a bioinformatic program.

Vita Land, MD, MBA

Basic Research

Defining the basic research technology requirements is an unfinished item of business for the PTTF. There are currently major transitions at CMIER and the new Director is engaged in an important strategic planning process. At the time this report was compiled this process was still actively under way and it was premature to propose recommendations. However, it is important to emphasize that the basic research enterprise have similar frustrations with technology support and a need for strategic investments in technology. There are important aspects of the basic and clinical research endeavors that would benefit from collaborative planning. CMIER is thus viewed as a key constituency in the proposed CCRC.

Informatics Research

Health care informatics is a fertile area for research. Bioinformatics techniques in decision support and molecular epidemiology share many common techniques and illustrate how complementary resources could be developed in an integrated facility. Informatics has defined itself as a discrete branch of medical science with professional associations, scholarly journals and training programs. Supporting the proposed CCRC will require a core group of faculty and staff in an Informatics Program. This will require a significant investment for the recruitment and development of faculty and staff for this Informatics Program.