SeluDex Regulatory Approvals

 

Substantial Amendment 01 (SA01) 19-Jul-2017

REC only amendment for changes following response to MHRA Grounds for Non-Acceptance

REC

HRA

Substantial Amendment 02 (SA02) 25-Oct-2017

REC & MHRA amendment including changes to outcome measures, response criteria and schedule of events

REC

MHRA

HRA

Substantial Amendment 03 (SA03) 08-Feb-2018

REC only amendment for a change of Chief Investigator and Principal Investigators

REC

HRA

Substantial Amendment 04 (SA04) 21-Mar-2018

MHRA only amendment for Reference Safety Information (used for assessment of SAEs not provided to sites) update and notification of change of Chief Investigator

MHRA

HRA

Substantial Amendment 05 (SA05) 05-Jun-2018

REC only amendment for change of Principal Investigator (Alder Hey)

REC

HRA

Substantial Amendment 06 (SA06) 20-Sep-2018

REC only amendment for change of Principal Investigator (Glasgow)

REC

HRA

Substantial Amendment 07 (SA07) 18-Dec-2018

Substantial Amendment 08 (SA08) 29-Mar-2019

MHRA only amendment for Reference Safety Information (used for assessment of SAEs not provided to sites) update

MHRA

HRA

Substantial Amendment 09 (SA09) 26-Apr-2019

REC only amendment for change of Principal Investigators (Great Ormond Street & Alder Hey) and addition of a site (Imperial)

REC

HRA

Substantial Amendment 10 (SA10) 08-May-2019

REC and MHRA Amendment following implementation of Urgent Safety Measure on 03-May-2019

REC

MHRA

HRA

Substantial Amendment 11 (SA11) 17-Sep-2019

Substantial Amendment 12 (SA12) 09-Oct-2019

Substantial Amendment 13 (SA13) 06-Dec-2019

REC & MHRA amendment including changes to schedule of events, DLT definitions, unequal splitting of AM & PM selumetinib dosing for paediatrics and other minor corrections/clarifications

REC

MHRA

HRA

Substantial Amendment 14 (SA14) 10-Mar-2020

REC only amendment for change of Principal Investigators (Bristol) and addition of a sites. (Imperial)

REC

HRA