GBR15

GBR16
GER13
Amicus
task owner due date reminder
tracker an summary submissions Irina 29-Jan-21
new SSUA for ZA Meroz Ketty 29-Jan-21
EOS draft -final Irina 30-Jan-21
done comments

not allocated yet

yes sent to KK for review 05Feb21
task owner due date reminder done
tracker for startup to incorporate the one of
Janelle Irina 2-Feb-21 partially

Clark response from feasibility meeting Colleen 22-Feb-21 29 Feb 21

budget UK Amicus 15-Feb-21
budget ITA Amicus 15-Feb-21
lab manual Amicus 15-Feb-21

ICFs for Mink Amicus 15-Feb-21

CDP changes docs to be sent to Rebecca Irina 1-Feb-21 partially
CDP changes docs to be sent to Rebecca Irina 1-Feb-21 partially
cover letter modificat Irina 2-Feb-21
ICFs for Williams Irina 29-Jan-21
ICFs for Specchio Irina 2-Feb-21
ICFs for Germany
ICFs for CostaRica Rosario 12-Feb-21
Reg Plan Irina/Laura 2-Feb-21
ICF include consent box for GP letter Irina
Stephanie
IRAS first draft /Irina 9-Feb-21
Dear Dr letter or GP letter irina
Contract at site Williams Irina

ICF include clarifications for consent mink

company relocation monica 10-Feb-21
ICFs Mink Irina 8-Feb-21
Timelines reassesed Laura
send updates on missing documents Irina 9-Feb-21
cover letter
New address confirmation
SDV data- check - cover
comments

still to be completed

was not reviewed. Waiting for site confirmation of feas

meeting

received 05 Feb 21 - to be updated with WIRB and

Amicus comments
pending signature
pending signature

check age of assent/consent 16 per IRAS

pending site sellection

for all country ICFs

pending lab
to clarify…
task owner due date reminder
cover letter draft - AE medical history
language- remote consent Irina 29-Jan-21
tracker for review Irina 29-Jan-21
check status of documents Irina 30-Jan-21
Reg Plan Hellen before first submssion
FMP signature page Irina 2-Feb-21
protocol signatyre page Irina
include wording in ICF fr SDV for exUS Irina 21-Mar
SDV plan Yasemin
McGuirk status Yasemin 1-Feb-21
CDAs Yasemin
Missing reports Yasemin
10% submissions adults Hellen
check NIHR validation budget Gonnzalo
new timelines
done comments

no sites CDAs
task owner due date reminder done
task owner due date reminder done

submission packages Yaara 1-Feb-21 29Jan21 4 feb21 5 feb 21

Turner approval amendmet Yaara 31-Jan-21 29Jan21 4 feb21 yes
training form Aoife Irina 5-Feb-21
submission cover pages Yaara 24-Feb-21 yes
follow up on approvals Irina 5-Mar-21
comments

sent 5feb21
task owner due date reminder done
mailbox requested Irina 29-Jan-21 yes

application to ANSM Irina 5-Feb-21

track feedback ansm Irina 10-Feb-21
comments

cover letter translated- MAG will help with consultation -08 Feb 21. Pilar still on sick leave. Alex
notified.
task owner due date reminder done
SSUA allocation for amedment Irina 29-Jan-21
Submission SWE03 confirmation
Contracts-GBR-15 Irina 29-Jan-21 29-Jan-21
GRE03 Irina 20-Dec 29-Jan-21

Insurance valid for entire study- send email to CRAs Irina 1-Feb-21
Insurance valid for entire study- update tracker Irina 1-Feb-21
Filipe -email ICF. Irina 2-Feb-21 partially
Upcoming submission site GBR17 Irina
Upcoming submission site IRL04 Irina
SSUA allocation Ireland Irina 8-Feb-21
comments
asked for FTE

CDP moved March

call on 8th Feb

pending selection Marti
site selected penfing allocation
confirmation from Isabelle if we wait for the amendment.
task owner due date reminder done
allocations Marc/Sam 10-Feb-21 yes
feasibility questionnaire Irina
comments

ask - feasibility - clin ops

task owner due date reminder done
allocations Marc/Sam 10-Feb-21 yes
email response KSA Marc 10-Feb-21