18 November 2010 | CAPRISA 008 protocol V.1.0 finalised and submitted to MCC |
20 January 2011 | First set of queries received from MCC |
28 January 2011 | Response to queries+V.1.1 of protocol submitted |
21 June 2011 | Request from MCC (5 months later) for a face-to-face meeting with the investigators on 1 July 2011 |
21 June 2011 | Response to MCC indicating that the principal investigators (PIs) were committed to conference presentations in the USA on this date and requested the meeting to be rescheduled after mid July 2011 |
14 July 2011 | Submission of CAPRISA 008 Ethics Committee approval to MCC |
20 August 2011 | Request from MCC for face-to-face meeting with the investigators on 26 August 2011 |
26 August 2011 | Investigators attend the face-to-face meeting at the MCC |
21 September 2011 | MCC requested a copy of the 1% tenofovir gel investigator's brochure (telephonic request)—4th edition of investigator's brochure (IB) (dated 12 November 2010) submitted via email |
4 October 2011 | MCC queries following discussions at the face-to-face meeting received |
12 October 2011 | Responses to queries submitted to the MCC |
16 November 2011 | Additional recommendations received from the MCC |
23 November 2011 | Response to the MCC's additional recommendations+V.2.0 of protocol submitted |
14 December 2011 | MCC requested the CAPRISA 004 CSR(telephonic request)—CAPRISA 004 draft CSR submitted to the MCC |
26 January 2012 | MCC hosted a scientific meeting on tenofovir-based vaginal microbicide gels |
28 February 2012 | MCC requested the final CAPRISA 004 CSR—MCC was informed that the final CAPRISA 004 CSR will be submitted to all regulators on or before 30 March 2012 |
12 March 2012 | Letter received from the MCC noting that the review of CAPRISA 008 will commence once the CAPRISA 004 final CSR has been submitted and analysed |
21 May 2012 | Full approval for protocol V.2.0 |
CSR, clinical study report; MCC, Medicines Control Council.