Evaluation of Structure – IRB composition and qualifications.

<p>Evaluation of Structure – IRB composition and qualifications.</p

Evaluation of Structure – IRB workload & different types of new non-exempt protocol reviews, 2010–2013.

<p>Evaluation of Structure – IRB workload & different types of new non-exempt protocol reviews, 2010–2013.</p

Effects of issues reviewed and notified for revision on “above target duration” in total time from submission to final approval (>60 days).

<p>*PR = Prevalence Ratio.</p><p>Effects of issues reviewed and notified for revision on “above target duration” in total time from submission to final approval (>60 days).</p

Evaluation of Process – Timeliness of protocol review, 2010–2013.

<p>Note:</p>a<p>Excludes 14 studies in 2010–2012 (6 withdrawn by investigator due to internal study team matters; 8 terminated by the Ethics Committee due to very long delay/non-response after notification).</p>b<p>Excludes 41 studies that required no revision.</p>C<p>Includes all new non-exempt study submissions.</p>d<p>Some studies were amended more than once.</p><p>Evaluation of Process – Timeliness of protocol review, 2010–2013.</p

Evaluation of Outcome - Decision on new non-exempt and continuing/amended protocols reviewed by FTM-EC, 2010–2013.

<p><i>Note: Excludes 7 studies that are pending decision outcome at data cutoff, and 13 studies withdrawn by PI (for various reasons) or by EC (due to long non-response period).</i></p

Evaluation of Outcomes - Ethical issues notified to researcher.

<p>Evaluation of Outcomes - Ethical issues notified to researcher.</p

IRB Metrics structure-process-outcome model used at FTM-EC.

<p>IRB Metrics structure-process-outcome model used at FTM-EC.</p

Benchmarking FTM-EC performance with selected indicators from AAHRPP-accredited institutes, 2012.

<p>*AAHRPP has compiled an information database from data supplied by 183 client organizations in 2012, <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0113356#pone.0113356-Donabedian1" target="_blank">[40]</a>.</p><p>Benchmarking FTM-EC performance with selected indicators from AAHRPP-accredited institutes, 2012.</p

Evaluation of Structure – IRB workload & number of protocols/documents reviewed, 2010–2013.

<p>Evaluation of Structure – IRB workload & number of protocols/documents reviewed, 2010–2013.</p

The proportion and geometric mean titer of NT dengue antibodies of 141 maternal and cord paired sera.

<p>Note: p-values for comparisons of seroprevalence are based on symmetry test; p-values for comparisons of GMTs between mother and cord are based on paired test of log (NT)</p><p>The proportion and geometric mean titer of NT dengue antibodies of 141 maternal and cord paired sera.</p