New data collection and storage tool helps studies manage regulatory documents
Keeping track of research-related regulatory paperwork just got easier thanks to use of REDCap, Penn State Clinical and Translational Science Institute’s data collection and storage tool. Penn State modified a similar project developed through partner members in the Clinical and Translational Science Award Network.
“With the trend towards electronic recordkeeping, there is increasing interest among the research community to create and manage essential and regulatory documents electronically,” said Paula Valencia-Moulton, manager of the Public Health Sciences Data Management Unit, which initiated the project. “In response to this need, the Public Health Sciences Data Management Unit in collaboration with the Penn State REDCap administrators and Research Quality Assurance office within the College of Medicine developed the Penn State e-Reg Binder.”
The e-Reg Binder helps study teams achieve and maintain regulatory compliance and adhere to federal, institutional and good clinical practice guidelines for research involving human subjects. It does this by making access to regulatory documents easier and increasing efficiency in organizing, maintaining and collating documentation. In addition, the tool reduces the time needed to print and store paper materials as well as decreases travel expenses for on-site monitoring visits.
The Data Management Unit adapted a similar binder created by the Partners Human Research Quality Improvement Program and Enterprise Research Infrastructure and Services, in affiliation with Harvard Catalyst, to meet Penn State standards for clinical research.
"An innovative feature of the Penn State e-Reg Binder is the addition of a multi-site clinical trial template, which will allow single- and multi-site studies to utilize this tool,” Valencia-Moulton said. “Penn State investigators can customize each of these templates to fit their study’s needs.”
The binder templates are for investigator-initiated trial use. Sponsored studies should follow the sponsor’s guidelines for storage of regulatory materials.
“From a research compliance standpoint, the e-Reg Binder will simplify the process of audits, inspections and general compliance requirements and requests for both the researcher and compliance team,” Nicole Matthews, Officer of Research Quality Assurance, College of Medicine said. “Because REDCap is so widely supported on the Hershey campus, a few clicks within a database will allow compliance teams to gather some of the vital study information remotely. The structure of the e-Reg binder and its ability to be customized for each study allows for a visual representation that allows one to quickly view which documents are available and applicable.”
The Data Management Unit plans to share its modifications back with Harvard for benefit of the Clinical and Translational Science Award Network.
The e-Reg Binder can be accessed on the Hershey campus through the Clinical Trials Office infonet page under Forms: Study Management. E-Reg materials and templates at University Park are controlled and overseen through the Quality Management office.