Form 1 International DTL Signing

OMB# 0925-0753 (Exp.5/31/2024)
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DTL Signed on 13-OCT-2023
Protocol Information
CTEP Document Number
A021502

Phase
III

Lead Protocol Organization
ALLIANCE

Protocol Title
Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients
with Stage III Colon Cancer and Deficient DNA Mismatch Repair
Site Information
Research Site Name
Saint Josef-Hospital Bochum

Site ID
76105

Address
Saint Josef-Hospital Bochum
Klinikum der Ruhr-Universität
Gudrunstrasse 56
Bochum, 44791 DE

Clinical Investigator Information
Person ID
IVR-610302

Name of Clinical Investigator
Reinacher-Schick, Anke

IRB of Record
IRB #

IRB Name

Address

IRB00011443

Ethik-Kommission der Medizinischen
Fakultät der Ruhr-Universität-Bochum
IRB #1

Gesundheitscampus 33
44801 Bochum
Bochum, GERMANY

Laboratory Information
No protocol specific labs required.

Page 1

Delegation of Tasks Log
#

Ctep Person ID

Person

Research Task

Clinical Investigator

1

IVR-610302

Reinacher-Schick, Anke

Consenting Person,Eligibility Assessment,End Point
Assessment,Enrolling Person/Treating Investigator,HP
Assessments,IND Prescribing,Investigational Product
Accountability,OPEN Registrar,Tox Assessment

Sub-Investigators
1

AP-643635

Foerster, Claudia

DTL Administrator,OPEN Registrar,Rave CRA
Consenting Person,DTL Administrator,Eligibility
Assessment,End Point Assessment,Enrolling
Person/Treating Investigator,HP Assessments,IND
Prescribing,OPEN Registrar,Rave CRA,Tox Assessment

2

IVR-644852

Kraeft, Anna-Lena

3

AP-664125

Kumkapi, Selma

4

IVR-661093

Lugnier, Celine

5

IVR-645120

Nopel-Dunnebacke,
Stefanie

6

AP-643679

Rohe, Gaby

OPEN Registrar,Rave CRA

7

AP-606332

Sandberg, Marlen

Consenting Person

8

IVR-659274

Schenker, Nina

Consenting Person,Eligibility Assessment,End Point
Assessment,Enrolling Person/Treating Investigator,HP
Assessments,IND Prescribing,Tox Assessment

Page 2

OPEN Registrar,Rave CRA
Consenting Person,Eligibility Assessment,End Point
Assessment,Enrolling Person/Treating Investigator,HP
Assessments,IND Prescribing,Tox Assessment
Consenting Person,Eligibility Assessment,End Point
Assessment,Enrolling Person/Treating Investigator,HP
Assessments,IND Prescribing,Tox Assessment

Commitments
I agree to conduct the protocol(s) in accordance with the relevant documents and will only make changes in a protocol
after notifying the sponsor or responsible organization, except when necessary to protect the safety, rights, or welfare of
subjects.
I agree to personally conduct or supervise the described investigation(s).
I agree to inform any patients, or any persons used as controls, that the agents/interventions are being used for
investigational purposes (if applicable) and I will ensure that the requirements relating to obtaining informed consent and
Independent Ethics Committee (IEC) review and approval in ICH E6, national and regional legislation, and the
Declaration of Helsinki are met.
I agree to report to the sponsor or responsible organization any adverse experiences that occur in the course of the
investigation(s) in accordance with ICH E6, national and regional legislation, and the Declaration of Helsinki. I have read
and understand the information in the investigator's brochure (if an investigational agent is being used) or approved
product labeling/marketing authorization literature, including the potential risks and side effects of the agent.
I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the protocol(s) are informed
about their obligations in meeting the above commitments.
I agree to maintain adequate and accurate records and to make those records available for inspection in accordance with
ICH E6, national and regional legislation, and the Declaration of Helsinki.
I will ensure that an IEC that complies with the requirements of ICH E6, national and regional legislation, and the
Declaration of Helsinki will be responsible for the initial and continuing review and approval of the clinical investigation. I
also agree to promptly report to the IEC all changes on the research activity and all unanticipated problems involving
risks to human subjects or others. Additionally, I will not make any changes in the research without IEC approval, except
where necessary to eliminate apparent immediate hazards to human subjects.
I agree to comply with all other requirements, regarding obligations of clinical investigators and all other pertinent
requirements in ICH E6, national and regional legislation, and the Declaration of Helsinki.

Signature
Signature

Date

Printed Name

Anke Reinacher-Schick

13-OCT-2023

Anke Reinacher-Schick

I have acknowledged and agree that my electronic signature is the legally binding equivalent to my handwritten signature.
Whenever I execute an electronic signature, it has the same validity and meaning as my handwritten signature. I will not, at
any time in the future, repudiate the meaning of my electronic signature or claim that my electronic signature is not legally
binding.

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