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A LOTUS NOTES APPLICATION FOR PREPARING, REVIEWING, AND STORING NHEERL RESEARCH PROTOCOLS
Citation:
Rogers, R R. AND J. C. Mabellos. A LOTUS NOTES APPLICATION FOR PREPARING, REVIEWING, AND STORING NHEERL RESEARCH PROTOCOLS. Presented at 20th Annual Conference on Managing Environmental Quality Systems, St. Louis, Missouri, 4/2-6/2001.
Description:
Upon becoming QA Manager of the Health Effects Research Laboratory (HERL) in 1990, Ron became aware of the need to simplify and streamline the research planning process that Laboratory Principal Investigators (Pls) faced. Appropriately, animal studies require close scrutiny, both in planning and in implementation. However, the planning process in place at HERL at that time involved three separate resource intense, overlapping/redundant, and yet divergent.protocol requirements. In order to comply with the Animal Welfare Regulations and Public Health Service Policy and to maintain AAALAC accreditation of our research program and animal facilities, PIs prepared detailed Laboratory Animal Project Review protocols (LAPRs) for each study in which they would use laboratory animals. These protocols were reviewed for approval by the Institutional Animal Care and Use Committee (IACUC). Each PI who planned to use hazardous biological or chemical agents in their research prepared a detailed Health and Safety Research Protocol for Hazardous Agents, which was reviewed for approval by the Laboratory Safety Committee. The key job of the HERL QA Manager was to ensure compliance with EPA Order 5360.1, which requires that each project be described in an approved QA Project Plan (QAPP) - the third research planning document. There had to be a better way!
Over the next 8 years, little was accomplished to address this widely recognized need to streamline this process. Then, in 1998, the National Health and Environmental Effects Research Laboratory (NHEERL), which was formed in 1995 by combining HERL and four ecological effects research laboratories, decided to employ Lotus Notes as the major platform for e-mail and a host of other Lab-wide functions. With that, the time had finally come to tackle in earnest the protocol merge task! In late 1998 a workgroup was convened to do so, consisting of nine NHEERL stakeholders representing the interests of QA, IACUC, Health & Safety, and the PIs. Since that time, four others with new QA or IACUC roles have been added to the workgroup.