Apr 3
Common Protocol Development Errors (Part Two) 
3 Apr, 2015. 0 Comments. News. Posted By: bflint
Some investigators are unclear about what to include in a research protocol vs. what is supplementary information. For example, some investigators may consider recruitment materials to be supplementary information. However, a complete protocol should specify the “recruitment plan,” describing how potential subjects will be identified and contacted. This description should contain details about how, when, where and by whom identified individuals will be approached about possible participation in the study. If, for example, the investigator needs to access medical records…
Feb 16
Common Protocol Development Errors (Part One)
16 Feb, 2015. 0 Comments. News. Posted By: bflint
It is a common sentiment among clinical investigators that the process of developing and submitting a human subject research protocol for review and approval by an IRB is onerous, lengthy and complicated. A protocol with missing, incomplete or incorrect information makes it difficult for an IRB to understand the trial, which can lead to increased protocol revisions, and delays in approval and enrolling participants. There is much that an investigator can do to improve the efficiency and turn-around time of IRBs by simply having a thorough and compliant protocol submission. The primary responsibility of an IRB is to…
Jan 19
Jan 13
BRANY launches Protocol Builder™ for investigator-initiated clinical trials
13 Jan, 2015. 0 Comments. News, Press Release. Posted By: bflint
Web-based and iPad tablet application solution for writing investigator-initiated research protocols (Lake Success, NY) — BRANY has announced the launch of Protocol Builder™, a first-of-its-kind solution to assist researchers in the development of investigator-initiated clinical trials protocols. This web-based application, accessible from any desktop and iPad tablet, is designed to provide expert guidance and a step-by-step process to make clinical trial protocol development faster and less onerous. Resources necessary to navigate the elaborate regulatory infrastructure that surrounds clinical research in the U.S. are at researchers’ fingertips in this thoughtfully designed application. “Many investigators find the regulatory and compliance hurdles difficult…
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