PAREXEL International
Subject Level Informed Consent Review Tracker
(One Form Per Subject)
SPONSOR: Astellas Pharma Global Development, Inc. (APGD) SPONSOR PROTOCOL NO: 8951-CL-0302
TEST ARTICLE: Zolbetuximab (IMAB362) PAREXEL PROJECT NO: 237098
PRINCIPAL INVESTIGATOR NAME: SITE NUMBER: 40006
Mihai Vasile MARINCA
Subject Screening Number: 4000610585 Subject Screening Date: 10/03/2020
Subject Randomisation Number: 4510 Language of Subject’s Informed Consent: Romanian
Name/Type of Version of Consent Date of Is If Yes, provide If No or NA, To be completed by To be completed by CSM
Consent Form Implementation Consent date of consent provide comment CSM CSM Review
(i.e. Main Study, Sub Study, at site Signed? If Yes, evidence (initials and date)
pK, Genomic, Imaging, etc) that copy of signed Add "to F/U" when Follow-
DD/MMM/YYY consent form given Up is required.(Once actions
Y to subject? taken check with " √ ")
☒Yes ☐
Yes
Partial ICF v1.0_20 Sep 2019 06-Dec-2019 ☐No 09/03/2020 ☐
No
☐NA
☒Yes ☐Yes
Main ICF v2.0_20 Sep 2019 06-Dec-2019 ☐No 09/03/2020 ☐No
☐NA
☐Yes ☐Yes
Partner Pregnancy v1.0 _29 Aug 2018 06-Dec-2019 ☐No ☐No
☐NA
☐Yes ☐Yes
Optional PGx v1.0_29 Aug 2018 06-Dec-2019 ☐No ☐No
☐NA
Name/Type of Version of Consent Date of Is If Yes, provide If No or NA, To be completed by To be completed by CSM
FM-CLN-WW-301-04 Project Version No.:1.0
Effective Date: 15 Nov 17 Project Effective Date:18Sept2018
Related to: SOP-CLN-WW-006 Page _ of _
PAREXEL International
Subject Level Informed Consent Review Tracker
Consent Form Implementation Consent date of consent provide comment CSM CSM Review
(i.e. Main Study, Sub Study, at site Signed? If Yes, evidence (initials and date)
pK, Genomic, Imaging, etc) that copy of signed Add "to F/U" when Follow-
DD/MMM/YYY consent form given Up is required.(Once actions
Y to subject? taken check with " √ ")
☐Yes ☐
Optional Post Progression v1.0_29 Aug2018 06-Dec-2019 ☐No ☐Yes
Tumor sample ☐NA No
☐Yes ☐
Dear Patient Letter 10 Apr 2020 08-May-2020 ☐No ☐Yes
☐NA No
FM-CLN-WW-301-04 Project Version No.:1.0
Effective Date: 15 Nov 17 Project Effective Date:18Sept2018
Related to: SOP-CLN-WW-006 Page _ of _
PAREXEL International
Subject Level Informed Consent Review Tracker
Guidance Notes for Completion by Site Staff
Language of Informed Consent: the language of Informed Consent used for the subject is to be recorded here e.g English.
Version of Consent refers to any identifier that allows to trace back the Consent. Recommended identifers include version number,
version date and document name.
Date of Implementation at site: This is the date from when the site is allowed to use the Informed Consent Form (ICF) to consent/re-
consent subjects, i.e. after all approvals are in place and available
Is Consent Signed? Yes/No/NA:
o If “Yes” then indicate the date when the subject signed the listed version of the ICF in the “If Yes, provide date of consent” column.
o When the subject should have signed the version listed but has failed to do so, mark “No”, and specify under the “If No or NA,
provide comment” column the reason why not, and what action will be taken to resolve.
o When the listed version of the ICF is not applicable to the subject (e.g. subject declined to join an optional sub study; subject has
already completed the visit(s) affected by the ICF changes and therefore the ICF changes are not applicable for the subject), then
mark “NA”.
FM-CLN-WW-301-04 Project Version No.:1.0
Effective Date: 15 Nov 17 Project Effective Date:18Sept2018
Related to: SOP-CLN-WW-006 Page _ of _
