SeluDex Regulatory Approvals

Initial Clinical Trial Application to REC, MHRA and HRA

Ethics

• REC Initial Application Cover Letter 06-Mar-2017 [227 KB .pdf]
• REC Acknowledgement of Valid Application 27-Mar-2017 [206 KB .pdf]
• REC Provisional Opinion 18-Apr-2017 [253 KB .pdf]
• REC Provisional Opinion Response Letter 31-May-2017 [367 .pdf]
• REC Request for Further Information 19-Jun-2017 [139 KB .pdf]
• REC Request for Further Information Response Letter 03-Jul-2017 [310 KB .pdf]
• REC Initial Favourable Opinion 12-Jul-2017 [277 KB .pdf]

MHRA

• MHRA Initial Application Cover Letter 06-Mar-2017 [390 KB .pdf]
• MHRA Acknowledgement of Valid Application 10-Mar-2017 [148 KB .pdf]
• MHRA Notice of Non-Acceptance 05-Apr-2017 [42 KB .pdf]
• MHRA Notice of Non-Acceptance Response Letter 24-Apr-2017 [155 KB .pdf]
• MHRA Clinical Trial Application Approval 05-May-2017 [1,054 KB .pdf]

HRA (Initial approval issued following SA01 & SA02)

• HRA Notification of Assessment Arrangements 28-Jul-2017 [117 KB .pdf]
• HRA Submission of Documents Following SA02 08-Dec-2017 [77 KB .pdf]
• HRA Initial Approval 12-Dec-2017 (Re-issued 20-Dec-2017) [246 KB .pdf]

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

REC

• REC SA01 Cover Letter 19-Jul-2017 [208 KB .pdf]
• REC SA01 Acknowledgement of Valid Amendment 20-Jul-2017 [132 KB .pdf]
• REC SA01 Favourable Opinion 01-Aug-2017 [82 KB .pdf]

HRA

• HRA SA01 Categorisation 20-Jul-2017 [219 KB .pdf]
• HRA SA01 Confirmation of Assessment Arrangements 01-Aug-2017 [171 KB .pdff]

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

REC

• REC SA02 Cover Letter 25-Oct-2017 [396 KB .pdf]
• REC SA02 Acknowledgment of Valid Amendment 02-Nov-2017 [138 KB .pdf]
• REC SA02 Favourable Opinion 28-Nov-2017 [140 KB .pdf]

MHRA

• MHRA SA02 Cover Letter 25-Oct-2017 [380 KB .pdf]
• MHRA SA02 Acknowledgment of Valid Amendment 02-Nov-2017 [90 KB .pdf]
• MHRA SA02 Approval 27-Nov-2017 [882 KB .pdf]

HRA

• HRA SA02 Categorisation 02-Nov-2017 [218 KB .pdf]
• HRA SA02 Confirmation of Assessment Arrangements 28-Nov-2017 [223 KB .pdf]

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

REC

• REC SA03 Cover Letter 08-Feb-2018 [274 KB .pdf]
• REC SA03 Acknowledgement of Valid Amendment 13-Feb-2018 [156 KB.pdf]
• REC SA03 Confirmation of Opinion of NHS Sites 08-Mar-2018 [31 KB .pdf]
• REC SA03 Favourable Opinion 08-Mar-2018 [96 KB .pdf]

HRA

• HRA SA03 Categorisation 13-Feb-2018 [191 KB .pdf]
• HRA SA03 Approval 13-Mar-2018 [133 KB .pdf]

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

• MHRA SA04 Cover Letter 21-Mar-2018 [269 KB .pdf]
• MHRA SA04 Acknowledgment of Valid Amendment 27-Mar-2018 [33 KB .pdf]
• MHRA SA04 Approval 26-Apr-2018 [799 KB .pdf]

HRA

• HRA SA04 Submission of Documents following SA04 06-Jun-2018 [9,240 KB .pdf]
• HRA SA04 Categorisation 08-Jun-2018 [19 KB .pdf]
• HRA SA04 Approval 08-Jun-2018 [16 KB .pdf]

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

REC

• REC SA05 Cover Letter 06-Jun-2018 [267 KB .pdf]
• REC SA05 Confirmation of Opinion of NHS Sites 11-Jun-2018 [36 KB .pdf]

HRA

• HRA SA05 Categorisation & Approval 11-Jun-2018 [468 KB .pdf]

REC only amendment for change of Principal Investigator (Glasgow)

REC

• REC SA06 Cover Letter 20-Sep-2018 [244 KB .pdf]
• REC SA06 Confirmation of Opinion of NHS Sites 27-Sep-2018 [120 KB .pdf]

HRA

• HRA SA06 Categorisation & Approval 25-Sep-2018 [130 KB .pdf]

REC and MHRA Amendment following implementation of Urgent Safety Measure on 17-Dec-2018

REC

• REC SA07 Cover Letter 18-Dec-2018 [276 .pdf]
• REC SA07 Acknowledgement of Valid Amendment 21-Dec-2018 [152 KB .pdf]
• REC SA07 Favourable Opinion 04-Jan-2019 [105 KB .pdf]

MHRA

• MHRA SA07 Cover Letter 18-Dec-2018 [276 KB .pdf]
• MHRA SA07 Acknowledgment of Valid Amendment 21-Dec-2018 [44 KB .pdf]
• MHRA SA07 Approval 21-Jan-2019 [31 KB .pdf]

HRA

• HRA SA07 Categorisation 21-Dec-2018 [8,259 KB .pdf]
• HRA SA07 Approvals Outstanding for HRA Assessment 03-Jan-2019 [60 KB .pdf]
• HRA SA07 Approval Pending 04-Jan-2019 [115 KB .pdf]
• HRA Submission of Documents following SA07 21-Jan-2019 [99 KB .pdf]
• HRA SA07 Approval 22-Jan-2019 [16 KB .pdf]

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

MHRA

• MHRA SA08 Cover Letter 28-Mar-2019 [437 KB .pdf]
• MHRA SA08 Acknowledgment of Valid Amendment 02-Apr-2019 [47 KB .pdf]
• MHRA SA08 Approval 05-May-2019 [47 KB .pdf]

HRA

• HRA SA08 Submission of Documents 29-Mar-2019 [8,011 KB .pdf]
• HRA SA08 Categorisation 01-Apr-2019 [7,990 KB .pdf]
• HRA SA08 Submission of Approval Letter 08-May-2019 [134 KB .pdf]
• HRA SA08 Approval 17-May-2019 [15 KB .pdf]

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

REC

• REC SA09 Cover Letter 26-Apr-2019 [435 KB .pdf]
• REC SA09 Confirmation of Opinion of NHS Sites 09-May-2019 [46 KB .pdf]

HRA

• HRA SA09 Categorisation & Approval 09-May-2019 [57 KB .pdf]

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

REC

• REC SA10 Cover Letter 08-May-2019 [369 KB .pdf]
• REC SA10 Acknowledgement of Valid Amendment 30-May-2019 [133 KB .pdf]
• REC SA10 Favourable Opinion 12-Jun-2019 [105 KB .pdf]

MHRA

• MHRA SA10 Cover Letter 08-May-2019 [384 KB .pdf]
• MHRA SA10 Acknowledgment of Valid Amendment 10-May-2019 [47 KB .pdf]
• MHRA SA10 Approval 24-May-2019 [47 KB .pdf]

HRA

• HRA Submission of Documents following SA10 24-May-2019 [134 KB .pdf]
• HRA SA10 Categorisation 30-May-2019 [9,129 KB .pdf]
• HRA SA10 Approval 12-Jun-2019 [112 KB .pdf]

REC and MHRA Amendment following implementation of Urgent Safety Measure on 10-Sep-2019

REC

• REC SA11 Cover Letter 17-Sep-2019 [294 KB .pdf]
• REC SA11 Acknowledgement of Valid Amendment 24-Sep-2019 [146 KB .pdf]
• REC SA11 Favourable Opinion 30-Sep-2019 [81 KB .pdf]

MHRA

• MHRA SA11 Cover Letter 17-Sep-2019 [293 KB .pdf]
• MHRA SA11 Acknowledgment of Valid Amendment 23-Sep-2019 [47 KB .pdf]
• MHRA SA11 Approval 25-Sep-2019 [47 KB .pdf]

HRA

• HRA Submission of Documents following SA11 26-Sep-2019 [179 KB .pdf]
• HRA SA11 Categorisation 27-Sep-2019 [32 KB .pdf]
• HRA SA11 Approval 30-Sep-2019 [93 KB .pdf]

MHRA only amendment for the addition of an IMP site in Germany

MHRA

• MHRA SA12 Cover Letter 26-Sep-2019 [336 KB .pdf]
• MHRA SA12 Acknowledgment of Valid Amendment 10-Oct-2019 [47 KB .pdf]
• MHRA SA12 Approval 14-Oct-2019 [47 KB .pdf]

HRA

• HRA SA12 Submission of Documents 09-Oct-2019 [1,768 KB .pdf]
• HRA SA12 Categorisation 22-Oct-2019 [32 KB .pdf]
• HRA SA12 Submission of Approval Letter 24-Oct-2019 [131 KB .pdf]
• HRA SA12 Approval 28-Oct-2019 [15 KB .pdf]

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

• REC SA13 Cover Letter 02-Dec-2019 [526 KB .pdf]
• REC SA13 Acknowledgement of Valid Amendment 17-Dec-2019 [150 KB .pdf]
• REC SA13 Favourable Opinion 23-Dec-2019 [116 KB .pdf]

MHRA

• MHRA SA13 Cover Letter 02-Dec-2019 [375 KB .pdf]
• MHRA SA13 Acknowledgment of Valid Amendment 11-Dec-2019 [47 KB .pdf]
• MHRA SA13 Approval 06-Jan-2020 [49 KB .pdf]

HRA

• HRA SA13 Categorisation 17-Dec-2019 [155 KB .pdf]
• HRA SA13 Approval Pending 23-Dec-2019 [199 KB .pdf]
• HRA Submission of Documents following SA13 07-Jan-2020 [69 KB .pdf]
• HRA SA13 Approval 15-Jan-2020 [15 KB .pdf]

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

REC

• REC SA14 Cover Letter 10-Mar-2020 [334 KB .pdf]
• REC SA14 Confirmation of Opinion of NHS Sites 20-Mar-2020 [39 KB .pdf]

HRA

• HRA SA14 Categorisation & Approval 20-Mar-2020 [58 KB .pdf]

Unit-wide approval of a cover letter to be provided with the adult PIS for patients who turn 16 years of age during trial participation

• HRA Age of Majority Cover Letter Approval 03-Jun-2020 [581 KB .pdf]

HRA only non-substantial amendment to extend the end of trial date to 31-Aug-2022

HRA

• HRA NSA01 Amendment Tool Submission 14-Aug-2020 [309 KB .pdf]
• HRA NSA01 Approval 10-Sep-2020 [15 KB .pdf]

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

MHRA

• MHRA SA15 Cover Letter 01-Apr-2021 [426 KB .pdf]
• MHRA SA15 Approval 05-May-2021 [140 KB .pdf]

HRA

• HRA SA15 Amendment Tool Submission 01-Apr-2021 [353 KB .pdf]
• HRA SA15 Submission of Documents 25-May-2021 [292 KB .pdf]
• HRA SA15 Approval 25-May-2021 [121 KB .pdf]

REC & MHRA amendment including clarification of screening process for central and local RAS mutation testing, flexibility additions to schedule of events, inclusion of additional RAS mutations tested for locally for eligiblity and other minor corrections/clarifications

REC

• REC SA16 Cover Letter 29-Apr-2021 [787 KB .pdf]
• REC SA16 Acknowledgement of Valid Amendment 12-May-2021 [206 KB .pdf]
• REC SA16 Favourable Opinion 25-May-2021 [118 KB .pdf]

MHRA

• MHRA SA16 Cover Letter 29-Apr-2021 [775 KB .pdf]
• MHRA SA16 Acknowledgment of Valid Amendment 14-May-2021 [47 KB .pdf]
• MHRA SA16 Approval 11-Jun-2021 [140 KB .pdf]

HRA

• HRA SA16 Amendment Tool Submission 29-Apr-2021 [375 KB .pdf]
• HRA SA16 Approvals Outstanding 21-May-2021 [139 KB .pdf]
• HRA SA16 Approval Pending 25-May-2021 [230 KB .pdf]
• HRA Submission of Documents following SA16 14-Jun-2021 [316 KB .pdf]
• HRA SA16 Approval 14-Jun-2021 [120 KB .pdf]