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The Regulatory Compliance module (Protocol Builder) reaches into the proposal record and pulls the starting
information for the creation of the protocol. The investigator then adds the research specific materials (such as abstracts, hypothesis, subject selection criteria, risk/benefit statements, etc. as sections of the protocol. Upon completing the protocol content, the system will automatically compile a Table of Contents from
the section and sub-section titles. Once the protocol is assembled, it is
submitted to the board as either a paper document, a PDF file attached
to an e-mail or a link to a special board member viewer of the
assembled protocol. Board review results will then update the
proposal and award records as required.
Protocols consist of a header, which identifies basic information like title, PI’s,
protocol type, pertinent dates, protocol status, etc., much of which can be pulled
from the proposal record; a table of contents (which is assembled automatically from
the section/subsection titles); sections (and sub-sections) which contain the actual content; and a signature page.
Each institution can create a standard protocol “template” for each protocol type. The template can be created from a completed protocol by simply saving the protocol’s structure, and can then be retrieved and used to build a new protocol by connecting to an existing proposal. The system will notify the designated compliance officer each time a protocol is submitted for review. The officer can view the submission directly through the application user interface or as a PDF document. The compliance office contact can also distribute access to the protocol to other committee members. The compliance office can make notes on the protocol, update its status and return the protocol to the PI.