Team # 474 -- Protocol Review And Management System (PRAMS)
Research

February 2002

Objective

PRAMS automates the review process for and data retention of protocols for research involving humans,
animals, biosafety and radioisotopes. This is accomplished through a web-based application and an imaging subsystem, which permits access to protocols being reviewed. The Office of Regulatory Compliance coordinates the review of more than 3,000 proposals annually.

Team Membership

  • Eva Pell, Sponsor
  • Ken Forstmeier, Leader
  • Chris Lose, Facilitator
  • Emily Broking, Member
  • Christy Cameron, Member
  • Peggy Considine, Member
  • Sharon Donachy, Member
  • Rich Gabel, Member
  • Kathleen Hay, Member
  • Stephanie Krout, Member
  • Jodi Mathieu, Member
  • Paula Morgan, Member
  • JoAnn Parsons, Member
  • Barbara Webb, Member
  • Candice Yekel, Member

Results Achieved to Date

  • Among the objectives for this improvement effort were to reduce data entry and procedural errors, to reduce costs, to reduce processing time, and to improve satisfaction with the protocol review process. Three significant ways costs and error rates were reduced include: developing a uniform administrative process for all protocol submission types (human, animal, biosafety, and radioisotope), consolidation of five separate databases into one, and automating the distribution of training certificates.
  • After the deployment of version 1.0, Penn State’s College of Medicine became involved. With its emphasis on clinical trials, the College of Medicine is bringing an important new perspective to system design.
  • In addition to basic improvements in PRAMS functionality, this has afforded the University to employ a best practices approach in order to make protocol processing and administration consistent between University Park and the College of Medicine.
  • The University is currently negotiating licensing PRAMS to a commercial software vendor.

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Contact

Office of Planning and Institutional Assessment
The Pennsylvania State University
502 Rider Building
University Park, PA 16802-4819
Phone: (814) 863-8721
Fax: (814) 863-7031
Email:

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