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South Africa Medical Journal (SAMJ), Feb 2013

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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South Africa Medical Journal (SAMJ), Feb 2013

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  1. South Africa Medical Journal (SAMJ), Feb 2013

  2. 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

  3. 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)

  4. Results • 15 TB vaccine trials (each to MCC and HREC) • 30 amendments across all trials (each to MCC and HREC)

  5. 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

  6. Results

  7.     All p > 0.1

  8. 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

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