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EditorialEDITORIALS
Open Access

Managing What You Can’t Measure—Institutional Review Board Decision Support Software

Stephen J. Rosenfeld
Ochsner Journal March 2020, 20 (1) 10-14; DOI: https://doi.org/10.31486/toj.19.0074
Stephen J. Rosenfeld
Freeport Research Systems, LLC, Freeport, ME
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Article Figures & Data

Figures

  • Figure 1.
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    Figure 1.

    In this context graphic, each circle represents a single study registered on clinicaltrials.gov of the intervention of interest. Studies are arranged horizontally by start date and vertically by the disorder being studied. The area of each study's disk is proportional to the planned or actual number of participants enrolled; the color of the disk indicates the status of the study (gray−completed, yellow−enrollment closed but study open, green−open and enrolling, red [not shown]−terminated). Studies with results reported on clinicaltrials.gov are enclosed in blue circles. Each disk also has a radial line corresponding to the clock-hand convention that indicates the phase of the study (eg, a phase 3 study has a radial at 3:00). Hovering the mouse over a disk reveals the full title of the study, and clicking a disk opens the corresponding webpage on clinicaltrials.gov. If a study has results, the results webpage will open. Notes: This figure is adapted from review tools developed by the author for personal use in institutional review board review. The actual names of disorders and interventions and the clinicaltrials.gov NCT numbers have been replaced by placeholder text. A color version of this graphic is available at www.ochsnerjournal.org.

  • Figure 2.
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    Figure 2.

    The history graphic has two sections. In the top section, each filled disk on the timeline represents a protocol or review event. For review events, disks are color coded to indicate if the review took longer than expected. For example, a red disk is a signal that the review discussion was extended and the record of that review is likely to be informative in the review of the protocol as a whole. Disks are arranged horizontally by date of occurrence and vertically according to the nature of the event. Hovering the mouse over an event disk reveals the meeting notes for that event, and clicking a disk opens the full record of that review. The bottom section of the graphic depicts the enrollment status and history of the study at each scheduled continuing review. A fully enrolled study is shown as a complete circle. The border of the disk is green if enrollment was open at the time of continuing review and red if it was closed. The interior is divided into colored slices (purple−active participants, red−participants who were withdrawn, and black−participants who have completed the study). As the graphic shows, enrollment typically begins with active participants, and over time, the number withdrawn or completed dominates. Notes: This figure is adapted from review tools developed by the author for personal use in institutional review board review. A color version of this graphic is available at www.ochsnerjournal.org.

  • Figure 3.
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    Figure 3.

    The precedent graphic shows other reviewed studies involving the same intervention (left panel) and indication (right panel). In the intervention panel, studies are organized horizontally by date of initial review and vertically by indication. In the indication panel, studies are organized horizontally by date of initial review and vertically by intervention. Hovering the mouse over a study disk reveals the full name of the study, and clicking a study disk opens the full review record. Similar graphics or actionable (clickable) text lists can be generated for studies that are similar in level of risk, use of placebo, or inclusion of minors. Notes: This figure is adapted from review tools developed by the author for personal use in institutional review board review. The actual interventions and indications in both panels have been replaced by placeholder text. A color version of this graphic is available at www.ochsnerjournal.org.

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Ochsner Journal: 20 (1)
Ochsner Journal
Vol. 20, Issue 1
Mar 2020
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Managing What You Can’t Measure—Institutional Review Board Decision Support Software
Stephen J. Rosenfeld
Ochsner Journal Mar 2020, 20 (1) 10-14; DOI: 10.31486/toj.19.0074

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Managing What You Can’t Measure—Institutional Review Board Decision Support Software
Stephen J. Rosenfeld
Ochsner Journal Mar 2020, 20 (1) 10-14; DOI: 10.31486/toj.19.0074
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