DOCUMENT NO.
Checklist
STATUS
EFFECTIVE DATE
EFFECTIVE
GDO-173
VERSION NO.
01-OCT-2012
PAGE NO.
V 1.0
Page 1 of 5
TITLE
Clinical Site Electronic Medical Records Checklist
This checklist is to be used to determine the appropriateness of an Electronic Medical Records system at clinical sites for Amgen
clinical studies. This checklist supports MAN-000211.
A separate checklist is to be used for each individual system in the same institution. The clinical site is to complete this checklist with
the help of the Clinical Monitor. The site is ultimately responsible for providing accurate and updated information for this checklist. If
necessary, some items in the checklist may need to be answered by Information Technology (IT).
1. General Information
Date Checklist was completed
(DD-MMM-YYYY):
Institution Name:
3/14/13
Institution Address:
2315 Stockton Blvd. |Sacramento, CA 95817
System Evaluated (system description;
include a thorough description of the
system to distinguish it from other
systems at the site):
System Version Number:
EPIC EMR
UC Davis Medical Center
Epic 2010 IU5, 4/14/13 we’re upgrading to Epic 2012 IU3
System Evaluated by (enter name of
Clinical Monitor):
Department(s) Using the System:
EMR System Administrator (cannot be
the Principal Investigator):
Name:
Phone:
Email:
System Administator contact information available upon request.
2. General
Assessment Criteria
Is the EMR system built in-house at the site or a
Commercial Off The Shelf (COTS) packages?
Include name of COTS in Comments Section.
Comments
In-House
Commercial Off The
Shelf Packages (including
customizations)
Amgen Confidential
EPIC software
DOCUMENT NO.
Checklist
STATUS
EFFECTIVE DATE
EFFECTIVE
GDO-173
VERSION NO.
01-OCT-2012
PAGE NO.
V 1.0
Page 2 of 5
TITLE
Clinical Site Electronic Medical Records Checklist
* Is documentation of the system validation available?
Please include the expiration date of the system validation
in the Comments Section.
Are the medical records recorded on paper, in an
electronic system or a combination of both?
Is the data entered directly into a computer system or is
there a paper record created first from which they are
transcribed/scanned?
Yes
No
Electronic
Paper
Both (explain in
comments field)
Computer system
Paper record first
Both (explain in
comments field)
In case of system failure, what back-up procedures are
available and how are they accessible?
Please provide more information in the comments field (eg,
backup medium, frequency of the backup, storage of the
backup, site of the backup location).
Have the site personnel been trained in the use of the
computer system?
If yes, please confirm training documentation is available
upon request.
Does the EMR system have a User Manual?
HIMMS Level 7
Backup procedures are maintained by our Business
Continuity staff and they’re accessible in each
Pharmacy.
Yes
No
Yes
No
How are modifications / system enhancements
handled?
Modifications and Enhancements are documented in
a ticket tracking system. Each ticket is triaged by the
IT application team, then reviewed by a clinical
committee for approval. Changes are then put in a
test environment, tested and processed through a
change management board for migration to
production.
3. Access
Amgen Confidential
DOCUMENT NO.
Checklist
STATUS
EFFECTIVE DATE
EFFECTIVE
GDO-173
VERSION NO.
01-OCT-2012
PAGE NO.
V 1.0
Page 3 of 5
TITLE
Clinical Site Electronic Medical Records Checklist
Is the computer hardware kept in a secure location?
Are the following controls in place to limit access to the
system?
 Unique user account (user ID and password)
 Automatically log off user after idle periods
 Locks user account after several failed log in
attempts
Is access to the electronic medical record system
restricted for staff by unique, identifiable login?
Is there a process for issuing and revoking user
access?
If satellite sites are used, how do satellite sites access
the system? Provide response in comments field.
Do all satellite sites have direct access to the EMR
system? If not, please explain further in comments.
Yes
No
Yes
Yes
Yes
No
No
No
Yes
No
Yes
No
Data Center
They connect to over a secure internet connection or
secure extended network. In each case Citrix is used
as the portal.
Yes
No
Yes
No
In the audit trail, are members of staff identified in the
system either by their names or a unique ID?
*Is the audit trail switched on from the point of data
entry?
Yes
No
Yes
No
Can the audit trail be edited?
Yes
No
4. Audit Trail
Is there an audit trail of all changes made to electronic
medical record system (ie, does the EMR retain a copy
of the original entry [or entries] as well as the name of
the person, date and time stamp of any changes)?
Auditing is turned on all the time in Epic.
(If YES is marked, continue to the question below)
5. Data Security
Amgen Confidential
Auditing is turned on all the time in Epic.
DOCUMENT NO.
Checklist
STATUS
EFFECTIVE DATE
EFFECTIVE
GDO-173
VERSION NO.
01-OCT-2012
PAGE NO.
V 1.0
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TITLE
Clinical Site Electronic Medical Records Checklist
Does the site have a written data storage/archival
policy for the electronic medical record system?
(If No is marked, explain in the comments field where and
how the medical records in the electronic record system are
to be stored)
(If Yes is marked, provide a brief summary of the policy in
the Comments section)
*Is the electronic data routinely archived as per legal
record retention requirements?
Can archived electronic medical records be retrieved
for a regulatory inspection after the study is closed?
Yes
No
Yes
No
Yes
No
Yes
No
Access granted through Citrix to the Read only EMR
environment once all appropriate access and HIPAA
paperwork has been completed
Yes
No
yes we can give access to any user "read/view only"
security level
mentors are trained by the respective department's
subject matter experts SME, they may also take
advantage of our "just in time" training available online on our intranet
Yes
No
Yes
No
Yes
No
6. Clinical Monitor Access
*Are sponsor staff (ie, Clinical Monitor, Compliance
Auditor) allowed to have read-only access to the EMR
system as described in the MAN-000211 Section 5.3?
Document the process to gain access in the Comments
section.
Is access read-only and limited to subjects on Amgen
studies?
How will the site train the Clinical Monitor in the use of
the EMR system? Explain in comments field.
If using Limited Supervised Access / Printouts:
 Do the paper printouts display the full user ID or
name, date and time?
 Are printouts signed / dated by the site staff to
confirm that they are a complete and true
representation of the data in the system?
 Is site prepared to resource over the shoulder
Amgen Confidential
DOCUMENT NO.
Checklist
STATUS
EFFECTIVE DATE
EFFECTIVE
01-OCT-2012
GDO-173
VERSION NO.
PAGE NO.
V 1.0
Page 5 of 5
TITLE
Clinical Site Electronic Medical Records Checklist
access?
The asterisks (*) are for internal use only
Note: Clinical Monitor to send this completed checklist to the CTA. CTA to store the final version in EPIC and a copy in EDM Teams.
Amgen Confidential