Research Determination

Print Date: 10/24/24

Title:

CryptoNet Case Report Form Amendment 1

Project Id:

0900f3eb824754b2

Accession #:

NCEZID-DWASHEPI-1/20/21-7d96e

Project Contact:

Amy L Freeland

Organization:

NCEZID/DFWED/WDPB

Status:

Pending Clearance : Amendment

Intended Use:

Project Determination

Estimated Start Date:

01/03/2022

Estimated Completion Date:

01/31/2028

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations

0920-1360

Determination

Justification

Completed

Entered By & Role

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance
10/24/24

Peterson_James M. (iyr1) CIO HSC

PRA:
PRA Applies

10/24/24

Vice_Rudith (nhr9) OMB / PRA

ICRO:
Returned with No Decision

2/17/21

Zirger_Jeffrey (wtj5) ICRO Reviewer

45 CFR 46.102(l)(2)

Description & Funding
Description
Priority:

Standard

Date Needed:

11/30/2024

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

10/22/24

Description:

This case report form will collect epidemiologic information on sporadic and outbreak-associated cryptosporidiosis cases for which
molecular subtyping has been conducted.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

To meet the needs of the CryptoNet, the Case Surveillance node, and the needs of local officials, CryptoNet case report form (CRF)
was developed. The CRF includes a set of data elements that can be used to identify exposure trends in outbreak- and nonoutbreak-associated Cryptosporidium cases, to generate hypotheses about the source(s) of infection in clusters or outbreaks, and
to identify strategies to prevent and control cases, clusters, or outbreaks.

Objective:

Administration of the CRF is to conduct surveillance on exposures associated with Cryptosporidium cases to better inform
prevention and control strategies for these infections. There are no research questions addressed. Standardized data will be
compiled on recent exposures related to cryptosporidiosis with the intention to inform disease prevention and control activities and
will not be used to inform generalizable knowledge. Staff in CryptoNet and the Case Surveillance node in WDPB will oversee data
management, analyses, and dissemination of data collected with the CRF during cryptosporidiosis investigations. The data
collected from the CRF will be used to inform exposure trends among cases, clusters, or outbreaks with the intention to identify and
implement prevention and control strategies and recommendations.

Does your project measure health disparities among No
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

No

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

Yes

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Cryptosporidiosis ; Public Health Surveillance ; Risk Factors

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided

Method Categories:

Individual Interview (Quantitative); Individual Interviews (Qualitative); Outbreak Investigation; Surveillance Support

Methods:

Cases, Clusters, and Outbreaks: The CRF will be administered by state and local public health officials via telephone interviews
with cases of cryptosporidiosis, or their proxy, who meet the following definitions: Multi-state cluster or outbreak: Multi-state clusters
are defined as at least two cases of cryptosporidiosis from different states that are either molecularly related or epidemiologically
related. Multi-state clusters and outbreaks are identified in multiple ways, including, but not limited to: through CryptoNet laboratory
molecular subtyping, states reaching out to CDC for technical assistance, and through media scans. Single-state cluster or
outbreak: Single-state cluster or outbreaks are defined as at least two cases of cryptosporidiosis from the same state that are either
molecularly related or epidemiologically related. Single state clusters and outbreaks are identified in multiple ways, including, but not
limited to: through CryptoNet laboratory molecular subtyping, states reaching out to CDC for technical assistance, and through
media scans. Non-outbreak associated cases: Non-outbreak-associated cases are defined as a cryptosporidiosis cases with no
known molecular or epidemiological association to another cryptosporidiosis case. Non-outbreak-associated cases are identified
through CryptoNet laboratory molecular subtyping, states reaching out to CDC for technical assistance, through healthcare
professionals contacting CDC, state, or local health departments, and through media scans. Participants: Respondents will be
cryptosporidiosis cases that meets one of the aforementioned definitions, or their proxy. Participation in the interview is voluntary.
Recruitment: Officials in state and local public health departments will contact laboratory confirmed cryptosporidiosis cases that

meet one of the aforementioned definitions, or their proxy, to conduct the interviews. CRF Content: The CRF contains questions on
the following content areas that would allow for characterizing the case and for identifying possible modes of transmission and
exposure settings of importance. This includes: (1) Associated IDs for other surveillance systems, (2) Demographics characteristics,
(2) Laboratory testing information, and (3) Symptom onset and exposure information. Specific exposure areas of the CRF include:
(1) Recent travel, (2) Recreational water contact, (2) Drinking water source, (4) Consumption of raw or unpasteurized foods and
beverages, (5) Recent large gatherings, (6) Childcare exposures, (7) Animal contacts and contact with animal environments, and (8)
Recent sexual encounters. The CRF collects limited personally identifiable information (PII). PII collected in the form includes case
age, sex, race, ethnicity, and county of residence. The collection of this PII is important to identify whether disparities among
subpopulations of cases exist and to ensure prevention and control measures can be tailored to specific subpopulations. The CRF
was developed based on subject matter expertise of CryptoNet and Case Surveillance node staff and was reviewed by staff in the
WDPB. Sampling: No sampling will be involved in the administration of the CRF. Officials in state and local public health
departments will contact cases of cryptosporidiosis, or their proxies, who meet the aforementioned definitions to ask if they would be
willing to complete the CRF. Incentives: No incentives will be provided to individuals completing the CRF.

Collection of Info, Data or Biospecimen:

The CRF will be administered by state and local public health officials via telephone interviews with cases of cryptosporidiosis, or
their proxy, who meets the aforementioned definitions. Collection of the CRF data elements will primarily employ standardized,
quantitative methods. Minimal qualitative methods will be used to elicit additional information about potential exposures from
respondents. For example, when case reports traveling outside their home state, the interviewer would ask about the specific travel
destination(s), dates of the travel, and any specific events the case participated in while traveling. There are no research questions
addressed through this data collection activity. Standardized data will be compiled on recent exposures related to cryptosporidiosis
to inform prevention and control efforts. Data will be used to inform case, cluster, and outbreak prevention and control activities and
will not be used to inform generalizable knowledge. Staff in CryptoNet and the Case Surveillance node in WDPB will oversee data
management, analyses, and dissemination of information collected with the CRF.

Expected Use of Findings/Results and their impact:

Administration of the CRF is to conduct surveillance on exposures associated with Cryptosporidium cases to better inform
prevention and control strategies for these infections as well as clusters and outbreaks. There are no research questions
addressed; standardized data will be compiled on recent exposures related to cryptosporidiosis cases and outbreaks. The data
collected from the CRF will be used to inform exposure trends among cases, clusters, or outbreaks with the intention to identify and
implement prevention and control strategies and recommendations. Aggregated summaries of CRF findings to describe
epidemiologic trends and outbreak investigations will be shared routinely, including CryptoNet state calls and internal CDC
meetings. Additionally, aggregated summaries of CRF findings may be shared externally through conference presentations and
peer-reviewed journal articles to describe epidemiologic trends, outbreak investigation activities, and prevention and control
strategies. Staff in CryptoNet and the Case Surveillance node in WDPB will oversee data analyses and dissemination of information
collected with the CRF unless an agreement is made with a state or local health department official.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the identifiers (including
coded data)?:

Yes

Is this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

No

Is there a formal written agreement prohibiting the

No

release of identifiers?

Funding

Funding yet to be added .....

HSC Review

Regulation and Policy
Do you anticipate this project will require review by
a CDC IRB or HRPO?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPAA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions

Will you be working with an outside Organization or Institution? Yes
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp.
Date

Amy
Freeland

12/19
/2026

Colleen
Lysen

07/13
/2026

Erin
Imada

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

Staff Role

Email

Phone

Organization

Project
Coordinator

igc3@cdc.
gov

--

Waterborne Disease
Prevention Branch

CoInvestigator

vqy1@cdc.
gov

4046394654

VIRAL SURVEILLANCE AND
DIAGNOSTIC BRANCH

03/17
/2026

Principal
Investigator

ioo6@cdc.
gov

4044985422

Domestic WASH Epi Team

Jasen
Kunz

06/26
/2026

CoInvestigator

izk0@cdc.
gov

7704887056

Domestic WASH Epi Team

Matthew
Seabolt

07/31
/2026

Program
Lead

ngr8@cdc.
gov

4047184163

Waterborne Disease
Prevention Branch

09/08/2026

07/30/2023

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

Data
DMP
Proposed Data Collection Start Date:

1/3/22

Proposed Data Collection End Date:

1/31/28

Proposed Public Access Level:

Public

Public Access Justification:

Data are public health surveillance data. Aggregated summaries of data obtained through this data collection will be released
annually to inform annual trends in exposures and other risks of cryptosporidiosis. On a per request basis, data may also be
released to researchers after ensuring all potentially personally identifiable information has been removed or aggregated sufficiently
to ensure protection of case-patient identity.

How Access Will Be Provided for Data:

Data will be securely stored on an Access database stored on a restricted network drive housed behind the CDC firewall.
Aggregated summaries to be published annually will contain no line-level personally identifiable information and case counts will not
be presented at a geographic level below the county. Case counts less than five will be masked at the county level. For data
released to researchers, line list data may be provided so long as no personally identifiable information is requested. All data will be
reviewed to ensure no personally identifiable information is released to the data requestor.

Plans for Archival and Long Term Preservation:

No paper-based CRFs will be maintained long-term. After entering the forms into the Access database stored behind the CDC
firewall, they will be destroyed.

Spatiality
Country

State/Province

County/Region

United States

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Supporting Info

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Current

Freeland_Amy
L. (igc3)
Project Contact

10/22/2024

Public health surveillance.

HS Research Determination Memo

021021ZM-NR-signed.pdf

Current

Freeland_Amy
L. (igc3)
Project Contact

10/22/2024

The CRF has removed the DOB
data element and will only collect
age. Let me know if other changes
are needed to the CRF.

Data Collection Form

CryptoNet form 2021.docx

Other, 0.1260 Request to End
Review of Human Research
Studies

Att C_CryptoNet Case Report Form_2024 version CLEAN (1).docx

Current

Freeland_Amy
L. (igc3)
Project Contact

10/22/2024

Updated CryptoNet Case Report
Form, with updated (1) race
/ethnicity question for compliance
with new HHS requirements, and
(2) lab testing options based on
current methodologies
/technologies

Current

Freeland_Amy
L. (igc3)
Project Contact

10/22/2024

This document provides additional
information on the proposed data
collection.

Other-Project proposal

Project Proposal_CryptoNet_01.13.2021.docx

Freeland_Amy
L. (igc3)
Project Contact

10/22/2024

This is the CryptoNet Case Report
Form for which we are seeking
approval. These data will
complement molecular subtyping
data obtained from laboratory
testing of specimens collected
from the same case.

Data Collection Form

CryptoNet form 2019.pdf

Peterson_James
M. (iyr1)
CIO HSC

02/10/2021

Public health surveillance.

HS Research Determination Memo

021021ZM-NR-signed.pdf

Marsh_Zachary
(ksf6)
Division
Approver
Projects

02/04/2021

The CRF has removed the DOB
data element and will only collect
age. Let me know if other changes
are needed to the CRF.

Data Collection Form

CryptoNet form 2021.docx

Marsh_Zachary
(ksf6)
Project Contact

01/20/2021

This document provides additional
information on the proposed data
collection.

Other-Project proposal

Project Proposal_CryptoNet_01.13.2021.docx

Data Collection Form

CryptoNet form 2019.pdf

Current

Marsh_Zachary
(ksf6)

01/20/2021

This is the CryptoNet Case Report
Form for which we are seeking
approval. These data will
complement molecular subtyping

Project Contact

data obtained from laboratory
testing of specimens collected
from the same case.