Form 87 Final Audit Finding

Attachment_D04_Final_Audit_Find

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July 2018

Attachment D04

Clinical Trials Monitoring Branch Final Report

Date: 10/10/2017
Page: 1 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:
Audit Location:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Date of Prior Audit:

Number of Cases Audited: 6

Average Annual Accrual: 10

Principal Investigator: Warren Lewis Robinson, Jr, MD

Institution Details
Institution CTEP Code

Institution Name

Role

PA042
PA412

Penn State Milton S Hershey Medical Center
Susquehanna Cancer Center

Main Member
Affiliate

Audit Outcome Summary
Component

Assessment

Follow up Required Follow up Due Reaudit Required
(Y/N)
Date
(Y/N)

IRB and Informed Consent Content Review

Acceptable

No

No

Accountability of Investigational Agents

Acceptable needs follow-up

Yes

No

Patient Case Review

Acceptable

No

No

Institution Staff
Robinson, Warren Lewis Jr (MD)
Yohn, Marianne (MMGT, CCRP)
Miller, Susan (RN, OCN)
Gaida, Michelle
Stank, Elaine (RN)
LeCrone, Joseph (PharmD)
Narret, Cindy (PSCHI)

Title
Senior Investigator
Clinical Trials Data Specialist
Clinical Trial Research Nurse
Executive Director, Cancer Services
Clinical Trial Research Nurse
Pharmacist
Clinical Trials Director

Affiliation
Susquehanna Cancer Center
Susquehanna Cancer Center
Susquehanna Cancer Center
Susquehanna Cancer Center
Susquehanna Cancer Center
Susquehanna Cancer Center
Susquehanna Cancer Center

Audit Team

Title

Affiliation

Lawson, David (MD)
Physician Auditor
Pitts, Susan (B.Sc., SRN)
ECOG-ACRIN Lead Auditor
Harwood, Suzanne (RN, BSN, OCN, CCRP) ECOG-ACRIN Lead Auditor

Emory University
ECOG-ACRIN Cancer Research Group
ECOG-ACRIN Cancer Research Group

Reaudit Time
(in months)

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 2 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Audit Location:

IRB Review
Protocol#

# of
IND or NCI
Patients Supplied Agents

A071102* (PA412)

1

CALGB-80702*
(PA412)
E1609 (PA412)

1

E1912* (PA412)

1

EAY131 (PA412)

1

1

ABT-888 (Veliparib)
(IND ,NCI/PMB)
Celecoxib (Celebrex)
(IND ,NCI/PMB)
Ipilimumab (BMS734016; MDX-010
Transfectoma-derived)
(IND ,NCI/PMB)
Ibrutinib (PCI-32765)
(IND ,NCI/PMB)
Dasatinib (BMS354825, Sprycel) (IND
,NCI/PMB), Sunitinib
malate (SU011248 Lmalate) (IND
,NCI/PMB), GDC-0449
(Vismodegib) (IND
,NCI/PMB), BMS936558 (Nivolumab,
MDX-1106) (IND
,NCI/PMB), Crizotinib
(PF-02341066) (IND
,NCI/PMB), Trametinib
(GSK1120212B) (IND
,NCI/PMB), Dabrafenib
(GSK2118436B) (IND
,NCI/PMB), Afatinib
(IND ,NCI/PMB),
AZD4547 (IND

Diseases

CTMB Guidelines Overall
Deficiency
IRB
Major / Lesser Deficiency Description of Deficiency and Comments

Glioblastoma multiforme

0/0

OK

Adenocarcinoma of the
colon
Melanoma

0/0

OK

0/0

OK

Chronic lymphocytic
leukemia, NOS
Lymphoma, NOS, Myeloma,
NOS, Solid tumor, NOS

0/0

OK

0/0

OK

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 3 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:
Audit Location:

Credited Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
Auditing Group: ECOG-ACRIN
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

IRB Review
Protocol#

# of
IND or NCI
Patients Supplied Agents

Diseases

CTMB Guidelines Overall
Deficiency
IRB
Major / Lesser Deficiency Description of Deficiency and Comments

,NCI/PMB), Palbociclib
(PD-0332991) (IND
,NCI/PMB), GDC-0032
(taselisib) (IND
,NCI/PMB), adotrastuzumab emtansine
(IND ,NCI/PMB),
AZD9291 (osimertinib)
(IND ,NCI/PMB),
GSK2636771B (IND
,NCI/PMB), VS-6063
(defactinib
hydrochloride) (IND
,NCI/PMB), AZD5363
(IND ,NCI/PMB),
Binimetinib (IND
,NCI/PMB)
Total# of Patients: 5

Total Protocols Reviewed: 5

Total Major/Protocol(s): 0/5

* after Protocol# indicates that Informed Consent Content was reviewed for that protocol

Total Lesser/Protocol(s):

0/5

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 4 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Audit Location:

Informed Consent Content (ICC) Review

Protocol#

Number of
Missing/Incomplete
Elements from ICC

A071102 (PA412)
CALGB-80702
(PA412)
E1912 (PA412)
Total# of Patients: 3

Overall
ICC
Deficiency

0
0

OK
OK

0

OK

Description of Missing/Incomplete Elements and Comments

Total Protocols Reviewed: 3

Total Major/Protocol(s): 0/3

IRB and Informed Consent Content Assessment
IRB and Informed Consent Content assessment:

Acceptable

Follow-up required for IRB deficiency:

No

Follow-up required for Informed Consent Content deficiency:

No

Re-audit required for IRB and Informed Consent Content section: No
Overall Comments:

Total Lesser/Protocol(s): 0/3

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 5 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Audit Location:

Pharmacy Review
Were INDs or NCI supplied agents used at this site during the period covered by this audit: Yes
Drug accountability checked during this audit: Yes
Number of NCI
Number of patients
DARFs compared to
cross checked with
Protocol#
shelf inventory
NCI
A071102 (PA412)
1
1
CALGB-80702 (PA412)
1
1
E1912 (PA412)
1
1
Compliant
[ ]

Non-Compliant
[X]

Not Reviewed
[ ]

NCI DARFs Completely and Correctly Filled Out
Protocol A071102 (PA412) Compliant
Protocol CALGB-80702 (PA412) Non-Compliant
COMMENTS: DATA MASKED
Deficiency: - Oral NCI DARF not maintained or not completely and accurately filled out

[

]

[X]

[

]

Protocol E1912 (PA412) Non-Compliant
COMMENTS: DATA MASKED
Deficiency: - Oral NCI DARF not maintained or not completely and accurately filled out
NCI DARFs Protocol and Agent specific
Protocol A071102 (PA412) Compliant

[

]

[

]

[X]

Protocol CALGB-80702 (PA412) Non-Compliant
COMMENTS: DATA MASKED
Deficiency: - Single DARF used for multiple patients/study participants on study when patient-specific DARF
should be maintained
Protocol E1912 (PA412) Compliant
Satellite Records of Dispensing Area
Protocol A071102 (PA412) Not Reviewed
COMMENTS: DATA MASKED
Protocol CALGB-80702 (PA412) Not Reviewed
COMMENTS: DATA MASKED

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 6 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Audit Location:
Compliant

[X]

Non-Compliant

[

]

Not Reviewed

[

]

Protocol E1912 (PA412) Not Reviewed
COMMENTS: DATA MASKED
NCI DARFs Kept as Primary Transaction Record
Protocol A071102 (PA412) Compliant
Protocol CALGB-80702 (PA412) Compliant

[X]

[

]

[

]

Protocol E1912 (PA412) Compliant
Return of Study Agent
Protocol A071102 (PA412) Compliant
Protocol CALGB-80702 (PA412) Compliant

[X]

[

]

[

]

Protocol E1912 (PA412) Compliant
Study Agent Storage
Protocol A071102 (PA412) Compliant
Protocol CALGB-80702 (PA412) Compliant

[X]

[

]

[

]

Protocol E1912 (PA412) Compliant
Adequate Security
Protocol A071102 (PA412) Compliant
Protocol CALGB-80702 (PA412) Compliant

[X]

[

]

[

]

Protocol E1912 (PA412) Compliant
Authorized Prescription(s)
Protocol A071102 (PA412) Compliant
Protocol CALGB-80702 (PA412) Compliant
Protocol E1912 (PA412) Compliant

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 7 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:
Audit Location:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Pharmacy Assessment
Pharmacy Assessment:

Acceptable needs follow-up

Follow-up Required:

Yes

Re-audit Required:

No

Pharmacy Narrative:

Ms. Harwood performed an on-site review of the control pharmacy located at Susquehanna Cancer Center with Joseph LeCrone, Pharm.D. The INDs
are being stored appropriately in the control pharmacy, and the control pharmacy has adequate security measures in place. There are ten members of
the control pharmacy staff who have access to the INDs. Ms. Pitts and Ms. Harwood reviewed the drug accountability record forms (DARFs) along
with the transaction forms (orders, receipts, returns, and/or transfers) for the control pharmacy for three of the INDs associated with the review of the
patient case records. There are no satellite pharmacies associated with this control pharmacy.

COMMENTS: Please provide a corrective and preventative action plan to ensure DARFs are completed accurately.

During the review of the control DARFs and transaction forms, all of the transactions recorded on the control DARFs coincided with the transaction
forms and the medical records.
However, the following noncompliance was noted:
C80702: The shelf inventory balance carried forward was not recorded on pages 2 or 3 of the DARF.
C80702: A single DARF for celecoxib/placebo capsules was maintained for two patients. The site discovered this non-compliance during
preparation for the audit and a CAPA dated 01/12/2017 was developed and has been appended to this report.
E1912: The shelf inventory balance carried forward was not recorded on pages 3 and 4 of the DARF.

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 8 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:
Audit Location:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Patient Case Review
Protocol#

Patient#

A071102 (PA412) 9103695

CALGB-80702
(PA412)

E1609 (PA412)

137686

17643

Category

Result

Description of Deficiency and Comments

Informed Consent

OK

Eligibility

OK

Treatment

OK

Disease Outcome/Response

OK

Adverse Event

Lesser

General Data Management
Quality
Informed Consent

OK

Eligibility

OK

Treatment

OK

Disease Outcome/Response

OK

Adverse Event

Lesser

Deficiency:
- Recurrent under- or over-reporting of adverse events
COMMENTS: DATA MASKED

General Data Management
Quality

Lesser

Deficiency:
- Recurrent missing documentation in the patient/study participant records
COMMENTS: DATA MASKED

Informed Consent

OK

Eligibility

OK

Treatment

OK

Disease Outcome/Response

OK

Adverse Event

Lesser

Deficiency:
- Recurrent under- or over-reporting of adverse events
COMMENTS: DATA MASKED

OK

Deficiency:
- Recurrent under- or over-reporting of adverse events
COMMENTS: DATA MASKED

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 9 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:
Audit Location:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Patient Case Review
Protocol#

Patient#

Category

Result

Description of Deficiency and Comments

E1609 (PA412)

17643

General Data Management
Quality

Lesser

Deficiency:
- Errors in submitted data
COMMENTS: DATA MASKED

E1912 (PA412)

19221

Informed Consent

OK

Eligibility

OK

Treatment

OK

Disease Outcome/Response

OK

Adverse Event

Lesser

General Data Management
Quality
Informed Consent

OK

Eligibility

OK

Treatment

Not Reviewed

Disease Outcome/Response

Not Reviewed

Adverse Event

OK

General Data Management
Quality
Informed Consent

OK
OK

OVERALL COMMENTS: DATA MASKED

Eligibility

OK

OVERALL COMMENTS: DATA MASKED

Treatment

Not Reviewed OVERALL COMMENTS: DATA MASKED
Not Reviewed OVERALL COMMENTS: DATA MASKED

EAY131 (PA412) 11311

S1207 (PA412)

261646
*Unannounced
Case

Disease Outcome/Response
Adverse Event
General Data Management
Quality

Deficiency:
- Recurrent under- or over-reporting of adverse events
COMMENTS: DATA MASKED

OK

Not Reviewed OVERALL COMMENTS: DATA MASKED
Not Reviewed OVERALL COMMENTS: DATA MASKED

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 10 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Audit Location:

Patient Case Review
Protocol#
A071102 (PA412)
CALGB-80702
(PA412)
E1609 (PA412)
E1912 (PA412)
EAY131 (PA412)
S1207 (PA412)

Patient#
9103695
137686

Informed Consent
OK
OK

Eligibility
OK
OK

Treatment
OK
OK

Disease Outcome /
Response
OK
OK

Adverse Event
Lesser
Lesser

General Data
Management Quality
OK
Lesser

17643
19221
11311
261646
*Unannounced
Case

OK
OK
OK
OK

OK
OK
OK
OK

OK
OK
Not Reviewed
Not Reviewed

OK
OK
Not Reviewed
Not Reviewed

Lesser
Lesser
OK
Not Reviewed

Lesser
OK
OK
Not Reviewed

Total # of Patient cases:

6

Total # of Major deficiencies: 0

Patient Case Review Assessment
Patient Case Review Assessment:

Acceptable

Follow-up required for Informed Consent:

No

Follow-up required for Eligibility:

No

Follow-up required for Treatment:

No

Follow-up required for Disease Outcome/Response:

No

Follow-up required for Adverse Event:

No

Follow-up required for General Data Management Quality: No
Reaudit required:

No

Total # of Lesser deficiencies:

6

Total # of items Not Reviewed: 6

Clinical Trials Monitoring Branch Final Report
Date: 10/10/2017
Page: 11 of 11

Run By: CTMBADMIN
Audit Date: 01/19/2017
Institution CTEP Code:
Audit Location:

Credited Group: ECOG-ACRIN
Auditing Group: ECOG-ACRIN
Audit Category: Treatment
Audit Type: Routine audit
PA412
Name: Susquehanna Cancer Center, Williamsport, Pennsylvania - 17701,
Membership Study Type: Treatment
USA
Susquehanna Cancer Center, 1100 Grampian Boulevard, Williamsport, Pennsylvania-17701, USA
DRAFT

Audit Procedures:

The ECOG-ACRIN Operation Center records were compared with the hospital records. The audit was conducted in accordance with CTMB Guidelines.

General Comments:

The auditors were very impressed with the quality of the documentation reviewed and the processes put in place at the site to ensure protocol
adherence.

Exit Interview Comments: Dr. Lawson, Ms. Pitts and Ms. Harwood conducted the exit interview with Dr. Robinson, and the staff noted on the first page of this audit report; Ms.
Narret attended by telephone. On behalf of the audit team, Ms. Pitts thanked Dr. Robinson and the staff for their hospitality, audit preparation,
assistance during the audit, and participation in ECOG-ACRIN.
Ms. Pitts indicated that the audit team will be recommending an Acceptable outcome for the regulatory review to the ECOG-ACRIN Audit Committee as
no deficiencies were noted in the review of the selected protocols and consent forms.
In the review of the pharmacy component, Ms. Pitts provided a summary of the noncompliance that was identified during the review of the DARFs and
pharmacy. Ms. Pitts indicated that the audit team will be recommending an Acceptable Needs Follow-up outcome for the pharmacy component to the
ECOG-ACRIN Audit Committee.
Dr. Lawson along with the other auditors reviewed the chart component and indicated that only lesser deficiencies were identified. An unannounced
case (S1207 Subject # 261646) was included in this audit and included a review of the informed consent and eligibility audit categories. The auditors
indicated that they found the source documentation to be very detailed. The charts were extremely well prepared and the CRAs were present to assist
the auditors with navigating the charts. In general, the site did an excellent job in obtaining the protocol-related parameters and ensuring that the
patients were treated according to the protocols. Ms. Pitts indicated that the audit team would be recommending an Acceptable outcome to the ECOGACRIN Audit Committee.
In preparation for the audit, the site identified the pharmacy non-compliance regarding the use of a DARF for the C80702 study; transactions for two
patients were reported on a single DARF when a separate DARF should have been used for each patient. Ms. Pitts acknowledged that the site provided
a copy of a corrective and preventative action (CAPA) plan in regard to this issue; that document is appended to this report. As an additional pharmacy
non-compliance was noted, when the audit report is finalized, ECOG-ACRIN will provide a copy of the report and request an amended or additional
CAPA plan. The CAPA plan must be submitted to ECOG-ACRIN within two weeks of receiving the final version of the audit report. The CAPA will need
to be reviewed and approved by the ECOG-ACRIN Audit Committee as well as the Clinical Trials Monitoring Branch.

Debra Springfield

02/02/2017

Prepared By

Date

Approved By

Date