Form 81 Elec Sig Page

Attachment A21_Elec_Sig_Page

OMB #xxxx-xxxx Expiration Date: xx/xx/xxxx

Example DTL Signed on 20-Feb-2020
Public reporting burden for this collection of information is estimated to average 10 minutes per
response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. An agency
may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. Send comments regarding this burden
estimate or any other aspect of this collection of information, including suggestions for reducing this
burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 208927974, ATTN: PRA (OMB#0925-0753). Do not return the completed form to this address.

Protocol Information
Protocol Title
A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients with Hormone
Receptor-Positive Advanced Breast Cancer
Phase

CTEP Document Number

Lead Protocol Organization

III

E2112

ECOG-ACRIN

Research Site Name

Site ID

Address

Ohio State University
Comprehensive Cancer
Center

OH007

410 West Tenth Avenue, Columbus, OH
43210 US

Site Information

Clinical Investigator Information
Person ID

Name of Clinical Investigator

IVR-39855

Ramaswamy, Bhuvaneswari

IRB of Record
IRB #

IRB Name

Address

IRB00000781

National Cancer Inst Central
IRB #1 (Adult)

401 N. Washington Street, 7th Floor,
Rockville, MD-20850

Laboratory Information
01D1069865, UNITED LAUNCH ALLIANCE, 100 ATLAS AVENUE MAIN BLDG 70, TRINITY, AL 35673
Delegation of Tasks Log
#

CTEP Person ID

Person

Research Task

Clinical Investigator

DTL Packet:
Revision 001 November 30, 2017

Page 1 of 3

Attachment A21_Elec_Sig_Page

OMB #xxxx-xxxx Expiration Date: xx/xx/xxxx

1 IVR-39855

Ramaswamy, Bhuvaneswari

Consenting Person, Eligibility Assessment,
Enrolling Person/Treating Investigator, HP
Assessments, Tox Assessment

1 AP-552557

Camp, Andrea Renee

Rave CRA

2 AP-540434

Gleich, Erica Lynn

Consenting Person, DTL Administrator

3 AP-535497

Laibach Thompson, Megan E. OPEN Registrar

4 AP-553233

Shegena, Eden

Rave CRA

5 AP-533592

Tolliver, Katlyn

DTL Administrator, OPEN Registrar

Sub-Investigators

Delegation of Tasks Log (Site Added Tasks Not Mandatory for this Protocol)
#

CTEP Person ID

Person

Research Task

1 AP-552557

Camp, Andrea Renee

Patient Screening/Recruiting

2 AP- 550606

Huhn, Carolyn Jane

RT/Imaging Support

3 A-509751

Jelinek, Kathryn Lynn

Patient Screening/Recruiting

Commitments


I agree to conduct the study in accordance with the relevant, current protocol and will only make changes in a
protocol after notifying the sponsor, 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 drugs are being used for investigational
purposes and I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and
institutional review board (IRB) review and approval in 21 CFR Part 56 are met.



I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance
with 21 CFR 312.64.



I have read and understand the information in the investigator's brochure, including the potential risks and side
effects of the drug.



I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed
about their obligations in meeting the above commitments.



I agree to maintain adequate and accurate records in accordance with 21 CFR 312.62 and to make those records
available for inspection in accordance with 21 CFR 312.68.



I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial
and continuing review and approval of the clinical investigation. I also agree to promptly report to the IRB all
changes in 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 IRB approval, except where necessary to
eliminate apparent immediate hazards to human subjects.



I agree to comply with all other requirements regarding the obligations of clinical investigators and all other
pertinent requirements in 21 CFR Part 312

DTL Packet:
Revision 001 November 30, 2017

Page 2 of 3

Attachment A21_Elec_Sig_Page

OMB #xxxx-xxxx Expiration Date: xx/xx/xxxx

Signature
Signature

Date

Bhuvaneswari Ramaswamy 20-Feb-2020

Printed Name
Bhuvaneswari Ramaswamy

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.

DTL Packet:
Revision 001 November 30, 2017

Page 3 of 3