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Managing Clinical Protocols That Safeguard Human Subjects

By Laura Hall
July 2010

Joan  Packenham, Ph.D.
"Before the Protocol Tracking and Management System, IRB administrators were dealing with huge paper files shuffled from desk to desk," said Packenham. "With central storage of files, PTMS eliminates the risk of misplacing documents and allows PIs and study staff to access their entire IRB study file." (Photo courtesy of Steve McCaw)

Darryl Zeldin, M.D.
"I'm extremely pleased with the job that the OHRC team did in rolling out the new Protocol Tracking and Management System, " said Darryl Zeldin, M.D., acting Clinical Director. "This new system will facilitate the IRB approval process for investigators." (Photo courtesy of Steve McCaw)

David Resnik, J.D., Ph.D.
"The new Protocol Tracking and Management System will streamline the IRB process by improving the speed of IRB expedited actions, since it does not require the chair to be on the NIEHS campus to sign documents," said NIEHS Bioethicist and IRB Chair David Resnik, J.D., Ph.D. (Photo courtesy of Steve McCaw)

On June 7, the NIEHS Office of Human Research Compliance (OHRC) launched a new paperless, integrated web-based system - the Protocol Tracking and Management System (PTMS). This system provides an electronic method for the submission, signing, tracking, review, and approval of information related to all NIEHS Institutional Review Board (IRB) activities. 

"The IRB's job is to safeguard the rights and welfare of human subjects by reviewing, approving, and monitoring proposed and continuing research activities involving human subjects within the NIEHS Intramural Research Program," said Joan Packenham, Ph.D., director of the NIEHS OHRC. "This system helps manage the process."

Training of all current NIEHS clinical principal investigators (PIs), study staff, and approving officials occurred during the month of May. New clinical PIs and study staff can receive PTMS training by contacting Andrea Glass, the NIEHS computer support trainer for the PTMS application.

PTMS Advantages

A major advantage of PTMS is that the IRB staff, approving officials, IRB members, principal investigators, and clinical study staff, can track and manage clinical protocols electronically in real-time - increasing efficiency. This system also allows for the paperless processing and approval of required Personal Financial Holding (PFH) forms by the NIEHS Office of Ethics. PFH forms are used to report any financial conflicts of interest for the investigators participating in the study.

The PTMS allows for electronic submission and approval by the NIH Office of Protocol Services (OPS) at the NIH Clinical Center, which serves as the final reviewing and approving authority for all IRB actions. Approving authorities and PIs sign documents digitally in the system.

Through this web-based system, clinical protocols are centrally stored, highly organized, and available 24 hours a day from any location with internet access. Investigators, study staff, and IRB members can access and review a protocol's history throughout the life-cycle of the protocol.

PTMS also facilitates IRB meetings, allowing for meetings to be paperless, giving reviewers easy access to protocol information and history, and capturing the reviewers' comments. In addition, IRB meeting agendas, minutes, and expedited action reports are generated and stored in the system.

The PTMS system was developed by the National Institute of Neurological Disorders and Stroke (NINDS) for government use. Nine of the twelve NIH Institutional Review Boards use this system for IRB protocol tracking and management. "The PTMS makes the IRB process from submission through approval more efficient," said Packenham.

(Laura Hall is a biologist in the NIEHS Laboratory of Toxicology and Pharmacology currently on detail as a writer for the Environmental Factor.)

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