Table 4

Amendment chronology

Amendment numberSummary of amendmentDocuments impacted (and version)Date sent for classificationDate classifiedDate sent to MHRADate of MHRA approvalDate sent to ethicsDate of ethics approvalDate sent to R and DDate of R and D approvalEffective date
1Contraceptive advice amendedProtocol 1.2 dated 24 May 20164 September 2016Minor 16 September 2016NANA21 June 201621 June 20164 September 2016NANA
2Changes in the priority of existing objectives and endpointsProtocol 2.0 dated 30 August 2016
PIS ICF 1.1 dated 19 April 2016
4 September 2016Substantial 16 September 2016NANA23 September 201627 September 201611 October 201619 January 2017NA
3Type of blood amended and volumeProtocol 2.1 dated 9 January 20179January 2017Substantial 30 January 2017NANA7 February 20171 March 20171 March 201714 March 201714 March 2017
Minor 20 January 2017Addition of Keith Lowry and Lesley McFaulNANANANANANANA20 January 201713 February 201713 February 2017
4Sample collection changeProtocol 3.04 April 2017Substantial 8 May 2017NANA8 May 20172 June 201710 May 201714 June 201715 June 2017
5Letter to potential participants, modify exclusion criteriaProtocol 4.0 dated 11 September 2017
Letter 1.0 dated 11 September 201711 September 2017Substantial 21 September 2017NANA29 September 201710 October 201710 October 20179 November 201716 November 2017
  • ICF, Informed Consent Form; MHRA, Medicines and Healthcare products Regulatory Agency; NA, not applicable; R and D, Research and Development.