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Enablement Day

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by

Michał Wichowski

on 14 May 2018

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Transcript of Enablement Day


2004
16 July 2012
21 May 2014
Citrine
server based
Diamond
Polaris
web based
IMPACT is affecting many processes
IMPACT as a enablement multi-tool

46 000
4000
STATISTICS
900 ongoing studies in GMD:
122 studies conducted by Poland HUB
253 outsourced
647 internal
448 620 patients signed ICF
MILESTONES
Approval date
FSI
LSLV + 30 days
SUBMISSION
Country
set up
Sites
set up
SQV
EC
SIV
Site and local
study personnel
FSI
Site
confirmation
..... LSLV....
Enablement
(IMPACT group)
Impact Administrator enters sites details
(addresses, PI details) - site „unconfirmed”

CRA: SQV Report + FU –
My sites

Site is qualified to the study – „site confirmed” (LSL or SA)

EC address details (National Coordinator) + chairman details

Recruitment plan entered on country and site level (LSL; Accord)

CRA: SIV Report +FU– My sites

Site and local study personel
entered to IMPACT by SA

CRA: MV Report +FU– My sites

Site and local study personel update

CRA: Update about patients in the site - on regular basis

SITE MANAGEMENT AND MONITORING
Clinical Trials Transparency
IMPACT
PharmaCM
We make it publicly visible! :)
Study Management Organization
IMPACT - daily work
Recruitment plans
ISF templates
ICF versions
Protocol versions
Protocol Deviations
Events dates (study progress)

From Impact to CSR
Protocol and amendments
IRB/ICF
Study Participants
Personnel at the study centre
AZ study personnel
Study committee(s)
Karolina Akus
Maciej Osiak
Maciej Osiak
Dorota Skuza
Dorota Skuza
Anna Oroń
Agnieszka Stepowska
Aleksandra Wotlińska
Marta Dorocińska
Dawid Łyżwa
Marta Dorocińska
Dawid Łyżwa
Joanna Złonkiewicz
How does the E-code look like?
Joanna Złonkiewicz
E + 4digits + 3digits
Eccccsss => cccc states for centre code, sss states for subject #

Karolina Akus
What does ABBA need form IMPACT?
1. ABBA is transfering and refreshing selected data form IMPACT daily.

2. What data is mapping from IMPACT?

A) study level: TA, protocol description, IMPACT study status, study planned and actual dates, study personnel.

B) country level: country name.

C) site level: site number.

Only the same site number from IMPACT

and the same 4 digits in E-code can ensure

the success!

PLANIT
Sylwia Tatulińska
Marlena Czekalska
Marlena Czekalska
Joanna Złonkiewicz
Thank you!
CTMS - Clinical Trials Management System
IMPACT in other activities
Michał Wichowski
Karolina Akus
Aleksandra Wotlińska
Dorota Skuza
Maciej Osiak
Marta Dorocińska
Dawid Łyżwa
Joanna Złonkiewicz
Anna Oroń
Agnieszka Stepowska
Marlena Czekalska
Sylwia Tatulińska
Full transcript