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Privacy Impact Assessment Form
v 1.47.4
Status Draft

Form Number

F-29298

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

P-4266791-346491

2a Name:

3/31/2020 3:37:21 PM

Research Electronic Data Capture (REDCap)
General Support System (GSS)
Major Application

3

Minor Application (stand-alone)

The subject of this PIA is which of the following?

Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Operations and Maintenance
Yes

3b Is this a FISMA-Reportable system?

4

Does the system include a Website or online
application available to and for the use of the general
public?

5

Identify the operator.

6

Point of Contact (POC):

7

Is this a new or existing system?

8

Does the system have Security Authorization (SA)?

8b Planned Date of Security Authorization

No
Yes
No
Agency
Contractor
POC Title

Business Steward

POC Name

Robert W Pinner

POC Organization CDC\OID\NCEZID
POC Email

RPinner@cdc.gov

POC Phone

404.639.7710
New
Existing
Yes
No
May 29, 2020
Not Applicable

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11 Describe the purpose of the system.
Describe the type of information the system will
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask
about the specific data elements.)
Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.
14 Does the system collect, maintain, use or share PII?

15

Indicate the type of PII that the system will collect or
maintain.

Research Electronic Data Capture (REDCap) is a data
management platform for collection, analysis, and visualization
REDCap is a data collection tool offered to CDC programs in
support of public health research and public health emergency
response. REDCap projects and data requirements vary from
public health research, laboratory research, emergency
REDCap is an open source software develop for scientific
research. The application was developed and maintained by
Vanderbilt University. Updates are managed and distributed
Yes
No
Social Security Number

Date of Birth

Name

Photographic Identifiers

Driver's License Number

Biometric Identifiers

Mother's Maiden Name

Vehicle Identifiers

E-Mail Address

Mailing Address

Phone Numbers

Medical Records Number

Medical Notes

Financial Account Info

Certificates

Legal Documents

Education Records

Device Identifiers

Military Status

Employment Status

Foreign Activities

Passport Number

Taxpayer ID

Employees
Public Citizens
16

Indicate the categories of individuals about whom PII
is collected, maintained or shared.

Business Partners/Contacts (Federal, state, local agencies)
Vendors/Suppliers/Contractors
Patients
Other

17 How many individuals' PII is in the system?

18 For what primary purpose is the PII used?

500-4,999
Most REDCap data projects do not contain PII. When PII is
solicited, it is because the CDC 's Principal Investigator (PI) for
each project leading that research project judges that PII may
be important for that public health response, e.g. clinical trial
follow-up after vaccine administration. The PI is responsible
for Office of Management and Budget (OMB) clearance and
communication about PII to respondents.

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19

Describe the secondary uses for which the PII will be
used (e.g. testing, training or research)

None

20 Describe the function of the SSN.

N/A

20a Cite the legal authority to use the SSN.

N/A

21

Identify legal authorities governing information use
Public Health Service Act, Section 306(b) (42 U.S.C. 242k)
and disclosure specific to the system and program.

22

Are records on the system retrieved by one or more
PII data elements?

Yes
No
Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources

23

Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other

Identify the sources of PII in the system.

Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other

23a

Identify the OMB information collection approval
number and expiration date.

24 Is the PII shared with other organizations?

If required, each individual project's program/Principle
Investigator (PI) is responsible for obtaining the OMB
information collection approval number. The PI is notified of
and acknowledges this responsibility through the completion
and acceptance of the REDCap Project Request Form. If OMB
clearance is require for a project, the REDCap Project Request
Form requires disclosure of the corresponding OMB
information collection approval number and expiration date.
Yes
No

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Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.

26

Is the submission of PII by individuals voluntary or
mandatory?

For all REDCap data projects, CDC requires the governmental
or non-governmental organizations (as defined in Q23 above)
contributing the information to capture consent with the
research or public health event by capturing a certified
electronic signature for each participant in the research
protocol or study. Each individual project's program/Principle
Investigator (PI) is responsible for ensuring processes are in
place to notify individuals that their personal information will
be collected. The PI is notified of and acknowledges this
responsibility through the completion and acceptance of the
REDCap Project Request Form.
Voluntary
Mandatory

For all REDCap data projects, CDC requires the governmental
or non-governmental organizations (as defined in Q23 above)
contributing the information to capture consent with the
Describe the method for individuals to opt-out of the research or public health event by capturing a certified
electronic signature for each participant in the research
collection or use of their PII. If there is no option to
27
protocol or study. Each individual project's program/principle
object to the information collection, provide a
investigator (PI) is responsible for implementing methods for
reason.
individuals to opt-out of the collection or use of their PII. The
PI is notified of and acknowledges these responsibilities
through the completion and acceptance of the REDCap Project
Request Form.
For all REDCap data projects, CDC requires the governmental
or non-governmental organizations (as defined in Q23 above)
contributing the information to capture consent with the
Describe the process to notify and obtain consent
research or public health event by capturing a certified
from the individuals whose PII is in the system when electronic signature for each participant in the research
major changes occur to the system (e.g., disclosure
protocol or study. Each individual project's program/Principle
28 and/or data uses have changed since the notice at
Investigator (PI) is responsible for implementing processes to
the time of original collection). Alternatively, describe notify and obtain consent from the individuals whose PII is in
why they cannot be notified or have their consent
the system when major changes occur to the system (e.g.,
obtained.
disclosure and/or data uses have changed since the notice at
the time of original collection). The PI is notified of and
acknowledges this responsibility through the completion and
acceptance of the REDCap Project Request Form.
Patient PII data are collected by governmental or nongovernmental organizations (as defined in Q23 above) and are
submitted to CDC in support of Public Health research or
events. CDC has no direct involvement in the PII collection
process or contact with the individuals. Each individual
project's program/Principle Investigator (PI) is responsible for
Describe the process in place to resolve an
periodic reviews of the integrity, availability accuracy, and
individual's concerns when they believe their PII has relevancy of PII collected. The PI is notified of and
29 been inappropriately obtained, used, or disclosed, or acknowledges this responsibility through the completion and
that the PII is inaccurate. If no process exists, explain acceptance of the REDCap Project Request Form.
why not.
CDC relies upon those organizations to have appropriate
processes and procedures in place to resolve individual
concerns regarding the accuracy and handling of the PII prior
to submission. However, upon request, the REDCap support
team will help research system logs or otherwise assist the PIs
with their investigations.

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Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.

Each individual project's program/Principle Investigator (PI) is
responsible for periodic reviews of the integrity, availability
accuracy, and relevancy of PII collected. The PI is notified of
and acknowledges this responsibilities through the
completion and acceptance of the REDCap Project Request
Form.
Users

Administrators
31

Identify who will have access to the PII in the system
and the reason why they require access.

Users require access for data entry
(open to all authorized users); Survey
Design and Data analysis (restricted to
CDC badged staff and direct
Administrators require access for
Application, User, Database, and Server
Management (restricted to CDC
badged staff and direct contractors).

Developers

Contractors

Direct contractors require access for
data entry, Survey Design and Data
analysis. Direct Contractors may act as
Administrators also.

Others
Describe the procedures in place to determine which The Business Steward is limiting access to the smallest possible
32 system users (administrators, developers,
number of people necessary to access PII data for conducting
contractors, etc.) may access PII.
official responsibilities through specific Role-based
Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.

Least privilege, Role Based Access methods are used to allow
those with access to PII to only access the minimum amount of
information necessary to perform their job. The system
administrator is responsible for setting up the user access to
the system based on the CDC user ID and the permissions
assigned to it.

Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.

All CDC personnel are required to complete annual Security
and Privacy Awareness Training.

Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

Third party governmental and non-governmental data
contributors receive role-based training regarding system
access rules of behavior on a study by study basis.

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?

Yes
No

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Each program using REDCap is responsible for applying its
own existing records retention schedules to PII data, and
schedules will vary across programs.

Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

Specifically to REDCap, the records are maintained in
accordance with General Records Schedule (GRS) and comply
with CDC Records Control Schedule (RCS). Final reports are
created to document programmatic decisions, policies, and
other related issues and are maintained permanently (CDC
RCS, B-321, 2&4). Input data of Non-electronic records
manually data entered are maintained and disposed of when
no longer needed: GRS 20.2a.4. Other input/output records are
disposed of when no longer needed: GRS 20.2a.4, 20.2d, and
20.6. Disposal methods include erasing computer tapes,
burning or shredding paper materials or transferring records to
the Federal Records Center when no longer needed for
evaluation and analysis.
Administrative controls: Completion of training requirements;
risk analyses performed annually; branch management
reviewing access requests and granting minimal amount of
access.

Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

Technical controls: Users are authenticated and data secured
using operating system and server security, administered by
the local system administrator. PII data is encrypted at rest and
in transits with access restricted to specific authorized users as
required by HHS and CDC policy. All user access to the REDCap
web application is authenticated via CDC's Digital Support
Office-Secure Access Management System (SAMS), including
authorized CDC users.
Physical- The server is housed on CDC property with gate
guards at the entrances to the property, individual user access
credentials are required for each non-public building , floor,
and office. Closed Circuit TV is also used by the internal
security guards to check for and grant access to authorized
individuals.

General Comments

OPDIV Senior Official
for Privacy Signature

signed by Jarell
Jarell Oshodi Digitally
Oshodi -S
Date: 2020.04.06 12:17:01
-S
-04'00'

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