Privacy Impact Assessment - REDCap

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Privacy Impact Assessment Form
v 1.47.4
Status Draft

Form Number

F-13599

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

P-6929567-366563

2a Name:

7/21/2022 9:44:14 AM

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)?

8a 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

[email protected]

POC Phone

404.639.7710
New
Existing
Yes
No

Sep 16, 2022

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11 Describe the purpose of the system.

Research Electronic Data Capture (REDCap) is a data
management platform for collection, analysis, and visualization
of public health research and event data. This system exists in
the CDC managed, FEDRamp approved

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
response, longitudinal studies, vaccine trial data, and other
public health event data. For example, the data may include
public health event studies that may collect information on
symptoms and environmental exposures that may be linked to
potential etiologic agents. In some circumstances, Personally
Describe the type of information the system will
Identifiable Information (PII) is collected for clinical or
collect, maintain (store), or share. (Subsequent
epidemiological follow-up and intervention. The exact nature,
12
questions will identify if this information is PII and ask type, and amount of PII collected will vary from survey to
about the specific data elements.)
survey but is limited to a subset of Name, Mother's Maiden
Name, E-Mail Address Mailing, Phone Numbers, Medical Notes,
Certificates, Education Records, Military Status, Foreign
Activities, Date of Birth, Photographic Identifiers, Mailing
Address, Medical Records Number, Legal Documents, Device
Identifiers, or Employment Status per survey.
All user access to the REDCap web application are
authenticated via CDC's Digital Support Office - Secure Access
Management System (SAMS), including authorized CDC users.
SAMS is a system with its own PIA.

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REDCap is an open source software develop for scientific
research. The application was developed and maintained by
Vanderbilt University. Updates are managed and distributed
by a consortium of partners that provide software support,
development and communication.
At the CDC REDCap is used for creating, fielding, and
managing large or small data collection projects. Data
collection projects encompass all facets of maintaining a
research or public health response effort in the field. This
includes data collection, management, analysis, and
visualization purposes. REDCap can also manage longitudinal
studies that capture repeated measures on a study cohort. It
also provides a comprehensive toolset to track study
participants and their compliance/participation with the
implemented research study protocol.
Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

REDCap projects and data requirements vary from public
health research, laboratory research, emergency response,
longitudinal studies, vaccine trial data, and other public health
event data. For example, public health event studies might
collect information on symptoms and environmental
exposures that might be linked to potential etiologic agents.
In some circumstances, PII is collected for clinical or
epidemiological follow-up and intervention but is limited to a
subset of Name, Mother's Maiden Name, E-Mail Address
Mailing, Phone Numbers, Medical Notes, Certificates,
Education Records, Military Status, Foreign Activities, Date of
Birth, Photographic Identifiers, Mailing Address, Medical
Records Number, Legal Documents, Device Identifiers, or
Employment Status per survey. The exact nature, type and
amount of PII collected will vary from survey to survey.
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. SAMS is a
system with its own PIA.

14 Does the system collect, maintain, use or share PII?

Yes
No

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15

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

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?

19

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

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.
None

20 Describe the function of the SSN.

Not Applicable. SSN are not collected or used.

20a Cite the legal authority to use the SSN.

Not Applicable. SSN are not collected or used.

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.

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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?

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?

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
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

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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.
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.

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Users

Administrators
31

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

Data entry (open to all authorized
users); Survey Design (restricted to
CDC badged staff and contractor); and
Data analysis (restricted to CDC
Application, User, Database, and Server
Management (restricted to CDC
badged staff and contractors).

Developers

Contractors

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

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
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). In accordance with
GRS 5.2, 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 Nonelectronic records manually data entered are maintained and
disposed of when no longer needed. Other input/output
records are disposed of when no longer needed: 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.

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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- Data is housed within the FEDRamp approved
Microsoft Azure facility within the CDC Office of the Chief
Information Officer (OCIO) managed tenant. The Azure data
center's physical security begins at the perimeter layer. This
layer includes a number of security features depending on the
location, such as security guards, fencing, security feeds,
intrusion detection technology, and other security measures
commensurate with the FEDRamp approval.
All components of the REDCap system reside in a CDC
managed, FEDRamp approved Azure environment.

General Comments

OPDIV Senior Official
for Privacy Signature

Q10: System has moved to the OCIO Azure Operating environment from the on-premises environment.

signed by Jarell
Jarell Oshodi Digitally
Oshodi -S
Date: 2022.07.27 15:05:15
-S
-04'00'

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