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Protocol Tracking and Management System (PTMS) is a secured web-based information management system designed to make the clinical protocol submission, review and approval processes more efficient, well organized, and accurate throughout the life cycle of a clinical research protocol. The system enables the principal investigators to initiate, track and organize any types of clinical studies, monitor review processes, view status changes, and quickly respond to reviewers or Institutional Review Board (IRB) requests for additional information, etc. In addition, it allows the protocol coordinators from different institutions to centrally track and manage the entire review and approval processes as well as regulatory reporting requirements. The new features with dynamic generated IRB meeting agenda and minutes, auto-generated IRB memos and electronic signatures completely eliminate the need for paper process and enable IRB office to fully automate the clinical protocol review processes from its initial submission, review to final approval.
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PTMS is a multi-tier web-based application that utilizes open source J2EE technology with Oracle database. With its open service oriented architecture (SOA) and modular designs, the system can be easily adapted to run on any Linux OS with any databases. Here are some highlights of features and functions that make PTMS successful and unique from other commercial or open source software:
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- Role based security and functions; users with multiple roles can auto-switch roles without re-login, the system will automatically adjust the data security assigned to the role.
- Central documentation repository for different review types with versioning controls throughout the life cycle of the protocol.
- An easy grid view of all the review status in one simple interface.
- Central management of all review actions (assign reviewers, meeting date, IRB approval, etc.) through one central review manager interface.
- Dynamic generated meeting agenda with links to each protocol that is assigned to that meeting date for IRB meeting on-line review.
- Allow on-line entry of meeting minutes during the IRB review meeting and auto-generate IRB memos with proposed actions.
- Auto email notifications and reminders throughout the review processes to keep PIs and IRB staff informed.
- Audit trails that record all actions and change history throughout the life cycle of each protocol.
- Powerful advanced and ad hoc search features that allows PIs and IRBs quickly query and export results for reporting.
- Additional features such as DSMB, SAE, conflict of interest and ethics reporting.
- Electronic signatures to enable full work flow automation and efficiency.
- Open software architecture and modular designs that can be quickly configured and adapted to any IRB workflow as well as linked to other data sources for data integration and reporting.
- Meets federal NIST security accreditation and certification standards.
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PTMS is currently used by NIH Combined Neuroscience IRBs (white and blue panels) which include NINDS, NIMH, NEI, NIAAA, and NIDCD. In addition, the system was recently deployed to NHGRI and will soon be utilized by NIDA, NIDDK/NIAMS, NIEHS and NIDCR.
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 PTMS has won the honorable recognition from Bio-IT World Best Practice Awards for 2008 in "Clinical Research" category, See the press release and Bio-IT World Web site:
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http://www.bio-itworld.com/2008/05/best-practices-winners.html
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http://www.bio-itworld.com/Corporate_Content.aspx?id=75256 |
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The PTMS system with source codes is freely available through a software transfer agreement (STA) from NINDS Technology Transfer Office; please contact Dr. Yang Fann (email: fann@mail.nih.gov) with your request and/or questions.
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* The United States government explicitly retains all rights to use the software for any purpose, to have it used on the government's behalf or to allow others to use it.
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