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South Africa Medical Journal (SAMJ), Feb 2013. Objective. Describe the median regulatory and ethics approval time for tuberculosis vaccine trials conducted at SATVI Describe approval time according to trial-specific protocol and submission factors. Method.
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Objective • Describe the median regulatory and ethics approval time for tuberculosis vaccine trials conducted at SATVI • Describe approval time according to trial-specific protocol and submission factors
Method TB vaccine trials conducted by SATVI (2004-2012) Approval Time= date of submission to date on approval letter Protocol factors By body (MCC; HREC)By submission (1st; amendment)
Results • 15 TB vaccine trials (each to MCC and HREC) • 30 amendments across all trials (each to MCC and HREC)
Results Median times (in days): 1st MCC 118 (112-175), range 71-350 HREC 59 (30-74) range 17-125 amendment MCC 103 (76-141), range 23-191 HREC 6 (4-13) range 1-37
All p > 0.1
Summary • Approval times: National Regulatory Body (MCC) is the driver • Determinants of review time: protocol factors vs capacity factors • Variability and unpredictability • 1st submission vs amendment