Attachment No. 24 PHS Human Subjects And Clinical Trials Info_3_0-V3.0.pdf

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HumanSubjectStudy_3_0-V3.0.pdf

D:20060509122150- 04'00'

D:20060509122150- 04'00'

OMB Number: 0925-0001

Expiration Date: 02/28/2023

Study Record: PHS Human Subjects and Clinical Trials Information

* Always required field

Section 1 - Basic Information

1.1. * Study Title (each study title must be unique)

1.2. * Is this Study Exempt from Federal Regulations?

1.3. Exemption Number

1.4. * Clinical Trial Questionnaire

If the answers to all four questions below are yes, this study meets the definition of a Clinical Trial.

1.4.a. Does the study involve human participants?

1.4.b. Are the participants prospectively assigned to an intervention?

1.4.c. Is the study designed to evaluate the effect of the intervention on the participants?

1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

1.5. Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable

Section 2 - Study Population Characteristics

2.1. Conditions or Focus of Study

2.2. Eligibility Criteria

2.3. Age Limits

Minimum Age

Maximum Age

2.3.a. Inclusion of Individuals Across the Lifespan

2.4. Inclusion of Women and Minorities

2.5. Recruitment and Retention Plan

2.6. Recruitment Status

2.7. Study Timeline

2.8. Enrollment of First Participant

2.9. Inclusion Enrollment Report(s)

OMB Number: XXXX-XXXX

Expiration Date: XX/XX/XXXX

Inclusion Enrollment Report

1. * Inclusion Enrollment Report Title

2. * Using an Existing Dataset or Resource

3. * Enrollment Location Type

4. Enrollment Country(ies)

5. Enrollment Location(s)

6. Comments

Planned

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female

Male

Hispanic or Latino

Female

Male

Total

American Indian/

Alaska Native

Asian

Native Hawaiian or

Other Pacific Islander

Black or African

American

White

More than One Race

Total

Cumulative (Actual)

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female

Male

Unknown/

Not

Reported

Hispanic or Latino

Female

Male

Unknown/

Not

Reported

Unknown/Not Reported Ethnicity

Female

Male

Unknown/

Not

Reported

Total

American Indian/

Alaska Native

Asian

Native Hawaiian or

Other Pacific Islander

Black or African

American

White

More than One Race

Unknown or Not Reported

Total

Report of

Section 3 - Protection and Monitoring Plans

3.1. Protection of Human Subjects

3.2. Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

Single IRB plan attachment

3.3. Data and Safety Monitoring Plan

3.4. Will a Data and Safety Monitoring Board be appointed for this study?

3.5. Overall Structure of the Study Team

Section 4 - Protocol Synopsis

4.1. Study Design

4.1.a. Detailed Description

Narrative Study Description: Enter the narrative study description.

4.1.b. Primary Purpose

4.1.c. Interventions

Intervention Type

Name

Description

4.1.d. Study Phase

Is this an NIH-defined Phase III clinical trial?

4.1.e. Intervention Model

4.1.f. Masking

4.1.g. Allocation

4.2. Outcome Measures

Name

Type

Time Frame

Brief Description

4.3. Statistical Design and Power

4.4. Subject Participation Duration

4.5. Will the study use an FDA-regulated intervention?

4.5.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status

4.6. Is this an applicable clinical trial under FDAAA?

4.7. Dissemination Plan

Section 5 - Other Clinical Trial-related Attachments

5.1. Other Clinical Trial-related Attachments

Form Attachments:

XDPFirstField:

Mandatory:

Study Title: Enter a unique title that describes the study that the participants are involved in. This is a required field.:

Is the Project Exempt from Federal regulations is required.:

Is the Study Exempt from Federal regulations? - Yes: Check to select.:

Is the Study Exempt from Federal regulations? - No: Check to select.:

T240:

Exemption Number 1: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 2: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 3: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 4: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 5: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 6: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 7: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 8: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

ExemptionNumber:

HumanSubjectsIndicator_Req:

Does the study involve human participants? - Yes: When a study record is created, "Yes" is set as the default value and cannot be edited.:

Does the study involve human participants? - No: When a study record is created, "Yes" is set as the default value and cannot be edited.:

InterventionAssigned_Req:

Are the participants prospectively assigned to an intervention? - Yes: Check to select.:

Are the participants prospectively assigned to an intervention? - No: Check to select.:

EvaluateIntervention_Req:

Is the study designed to evaluate the effect of the intervention on the participants? - Yes: Check to select. See agency-specific instructions for additional guidance. :

Is the study designed to evaluate the effect of the intervention on the participants? - No: Check to select. See agency-specific instructions for additional guidance.:

HealthRelatedOutcome_Req:

Is the effect that will be evaluated a health-related biomedical or behavioral outcome? - Yes: Check to select. See agency-specific instructions for additional guidance. :

Is the effect that will be evaluated a health-related biomedical or behavioral outcome? - No: Check to select. See agency-specific instructions for additional guidance. :

ClinicalTrials.gov Identifier: Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable.:

DataEntered:

Delete: Click to delete this entry.:

Conditions or Focus of Study: Identify the name(s) of the condition(s) you are studying or the focus of the study. See funding opportunity announcement and agency-specific instructions for additional guidance. :

Add New Intervention: Click to add another Intervention entry.:

Eligibility Criteria: List the study's inclusion and exclusion criteria. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Maximum Age: Enter the maximum participant age.:

Maximum Age Type: Provide the relevant unit of time.:

Inclusion of Individuals Across the Lifespan: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Inclusion of Individuals Across the Lifespan - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Inclusion of Individuals Across the Lifespan - View Attachment: Click to view this attachment.:

Inclusion of Individuals Across the Lifespan - Delete Attachment: Click to delete this attachment.:

FileName:

MimeType:

href:

hashAlgorithm:

HashValue_data:

Inclusion of Women and Minorities: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Inclusion of Women and Minorities - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Inclusion of Women and Minorities - View Attachment: Click to view this attachment.:

Inclusion of Women and Minorities - Delete Attachment: Click to delete this attachment.:

Recruitment and Retention Plan: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Recruitment and Retention Plan - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Recruitment and Retention Plan - View Attachment: Click to view this attachment.:

Recruitment and Retention Plan - Delete Attachment: Click to delete this attachment.:

Recruitment Status: Select one.:

Study Timeline: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Study Timeline - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Study Timeline - View Attachment: Click to view this attachment.:

Study Timeline - Delete Attachment: Click to delete this attachment.:

Add Inclusion Enrollment Report: Click to add the Inclusion Enrollment Report.:

Enrollment of First Participant: Enter the date in the format MM/DD/YYYY. :

Anticipated or Actual: Select one.:

Remove Inclusion Enrollment Report: Click to remove the Inclusion Enrollment Report.:

Inclusion Enrollment Report Title: An Inclusion Enrollment Report is required for all human subjects studies unless, on Question 1.3 “Exemption Number” you selected only Exemption 4 and no other exemptions. Entry is limited to 600 characters. There is a maximum of 20 IERs per Study Record.:

Using Existing Dataset or Resource is required.:

Using Existing Dataset or Resource - Yes: Check "Yes" if this study involves use of an existing dataset or resource. See agency-specific instructions for additional guidance.:

Using Existing Dataset or Resource - No: Check "No" if this study does not involve use of an existing dataset or resource. See agency-specific instructions for additional guidance.:

Enrollment Location Type is required.:

Enrollment Location - Foreign: Select "Foreign" if the participants described in the study are based at a non-U.S. site. Participants at U.S. and non-U.S. sites must be reported separately even if for the same study. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Enrollment Location - Domestic: Select "Domestic" if the participants described in the study are based at a U.S. site. Participants at U.S. and non-U.S. sites must be reported separately even if for the same study. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Enrollment Countries: Select the enrollment countries. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Enrollment Location(s): Enter the enrollment location(s) for participants (e.g., hospital, university, research center). See funding opportunity announcement and agency-specific instructions for additional guidance.:

Comments: Maximum 500 characters. See funding opportunity announcement and agency-specific instructions for additional guidance.:

American Indian Not Hispanic Female: Enter the number of females who are American Indian/Alaska Native and Not Hispanic or Latino.:

Asian Not Hispanic Female: Enter the number of females who are Asian and Not Hispanic or Latino.:

Hawaiian Not Hispanic Female: Enter the number of females who are Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino.:

Black Not Hispanic Female: Enter the number of females who are Black or African American and Not Hispanic or Latino.:

White Not Hispanic Female: Enter the number of females who are White and Not Hispanic or Latino.:

More than One Race Not Hispanic Female: Enter the number of females who identify with more than one racial category and are Not Hispanic or Latino.:

NotHispanicFemaleisValid:

Total Not Hispanic or Latino Female: This field is auto-calculated to total all racial categories for females who are Not Hispanic or Latino.:

American Indian Not Hispanic Male: Enter the number of males who are American Indian/Alaska Native and Not Hispanic or Latino.:

Asian Not Hispanic Male: Enter the number of males who are Asian and Not Hispanic or Latino. :

Hawaiian Not Hispanic Male: Enter the number of males who are Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino. :

Black Not Hispanic Male: Enter the number of males who are Black or African American and Not Hispanic or Latino.:

White Not Hispanic Male: Enter the number of males who are White and Not Hispanic or Latino.:

More than One Race Not Hispanic Male: Enter the number of males who identify with more than one racial category and are Not Hispanic or Latino.:

Total Not Hispanic or Latino Male: This field is auto-calculated to total all racial categories for males who are Not Hispanic or Latino.:

NotHispanicMaleisValid:

American Indian Hispanic Female: Enter the number of females who are American Indian/Alaska Native and Hispanic or Latino.:

Asian Hispanic Female: Enter the number of females who are Asian and Hispanic or Latino.:

Hawaiian Hispanic Female: Enter the number of females who are Native Hawaiian or Other Pacific Islander and Hispanic or Latino.:

Black Hispanic Female: Enter the number of females who are Black or African American and Hispanic or Latino.:

White Hispanic Female: Enter the number of females who are White and Hispanic or Latino.:

More than One Race Hispanic Female: Enter the number of females who identify with more than one racial category and are Hispanic or Latino.:

Total Hispanic or Latino Female: This field is auto-calculated to total all racial categories for females who are Hispanic or Latino.:

HispanicFemaleisValid:

American Indian Hispanic Male: Enter the number of males who are American Indian/Alaska Native and Hispanic or Latino.:

Asian Hispanic Male: Enter the number of males who are Asian and Hispanic or Latino.:

Hawaiian Hispanic Male: Enter the number of males who are Native Hawaiian or Other Pacific Islander and Hispanic or Latino.:

Black Hispanic Male: Enter the number of males who are Black or African American and Hispanic or Latino.:

White Hispanic Male: Enter the number of males who are White and Hispanic or Latino.:

More than One Race Hispanic Male: Enter the number of males who identify with more than one racial category and are Hispanic or Latino.:

Total Hispanic or Latino Male: This field is auto-calculated to total all racial categories for males who are Hispanic or Latino.:

HispanicMaleisValid:

Total American Indian/Alaska Native: This field is auto-calculated to total all American Indian/Alaska Natives. This is a required field. :

Total Asian: This field is auto-calculated to total all Asians.:

Total Hawaiian or Other Pacific Islander: This field is auto-calculated to total all Native Hawaiian or Other Pacific Islanders.:

Total Black or African American: This field is auto-calculated to total all Black or African Americans.:

Total White: This field is auto-calculated to total all Whites.:

Total More than One Race: This field is auto-calculated to total all individuals who identify with more than one racial category.:

Total: This field is auto-calculated to total all participants in all categories.:

Unknown Race Not Hispanic Female: Enter the number of females whose race is unknown/not reported and are Not Hispanic or Latino.:

Unknown Race Not Hispanic Male: Enter the number of males whose race is unknown/not reported and are Not Hispanic or Latino.:

American Indian Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are American Indian/Alaska Native and Not Hispanic or Latino.:

Asian Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Asian and Not Hispanic or Latino.:

Hawaiian Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino.:

Black Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Black or African American and Not Hispanic or Latino.:

White Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are White and Not Hispanic or Latino.:

More than One Race Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who identify with more than one racial category and are Not Hispanic or Latino.:

Unknown Race Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender, unknown/not reported race, and are Not Hispanic or Latino.:

Total Not Hispanic or Latino Unknown Sex: This field is auto-calculated to total all racial categories for individuals of unknown/not reported sex/gender who are Not Hispanic or Latino.:

NotHispanicUnknownGenderisValid:

Unknown Race Hispanic Female: Enter the number of females whose race is unknown/not reported and are Hispanic or Latino.:

Unknown Race Hispanic Male: Enter the number of males whose race is unknown/not reported and are Hispanic or Latino.:

American Indian Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are American Indian/Alaska Native and Hispanic or Latino.:

Asian Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Asian and Hispanic or Latino.:

Hawaiian Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Native Hawaiian or Other Pacific Islander and Hispanic or Latino.:

Black Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Black or African American and Hispanic or Latino.:

White Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are White and Hispanic or Latino.:

More than One Race Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who identify with more than one racial category and are Hispanic or Latino.:

Unknown Race Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender, unknown race, and Hispanic or Latino.:

Total Hispanic or Latino Unknown Sex: This field is auto-calculated to total all racial categories for individuals of unknown/not reported sex/gender who are Hispanic or Latino.:

HispanicUnknownGenderisValid:

American Indian Unknown Ethnicity Female: Enter the number of females who are American Indian/Alaska Native and of unknown/not reported ethnicity.:

Asian Unknown Ethnicity Female: Enter the number of females who are Asian and of unknown/not reported ethnicity.:

Hawaiian Unknown Ethnicity Female: Enter the number of females who are Native Hawaiian or Other Pacific Islander and of unknown/not reported ethnicity.:

Black Unknown Ethnicity Female: Enter the number of females who are Black or African American and of unknown/not reported ethnicity.:

White Unknown Ethnicity Female: Enter the number of females who are White and of unknown/not reported ethnicity.:

More than One Race Unknown Ethnicity Female: Enter the number of females who identify with more than one racial category and of unknown/not reported ethnicity.:

Unknown Race Unknown Ethnicity Female: Enter the number of females of unknown/not reported race and of unknown/not reported ethnicity.:

Total Unknown Ethnicity Female: This field is auto-calculated to total all racial categories for females of unknown/not reported ethnicity.:

UnknownEthnicityFemaleisValid:

American Indian Unknown Ethnicity Male: Enter the number of males who are American Indian/Alaska Native and of unknown/not reported ethnicity.:

Asian Unknown Ethnicity Male: Enter the number of males who are Asian and of unknown/not reported ethnicity.:

Hawaiian Unknown Ethnicity Male: Enter the number of males who are Native Hawaiian or Other Pacific Islander and of unknown/not reported ethnicity.:

Black Unknown Ethnicity Male: Enter the number of males who are Black or African American and of unknown/not reported ethnicity.:

White Unknown Ethnicity Male: Enter the number of males who are White and of unknown/not reported ethnicity.:

More than One Race Unknown Ethnicity Male: Enter the number of males who identify with more than one racial category and of unknown/not reported ethnicity.:

Unknown Race Unknown Ethnicity Male: Enter the number of males of unknown/not reported race and of unknown/not reported ethnicity.:

Total Unknown Ethnicity Male: This field is auto-calculated to total all racial categories for males of unknown/not reported ethnicity.:

UnknownEthnicityMaleisValid:

American Indian Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are American Indian/Alaska Native and of unknown/not reported ethnicity.:

Asian Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Asian and of unknown/not reported ethnicity.:

Hawaiian Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Native Hawaiian or Other Pacific Islander and of unknown/not reported ethnicity.:

Black Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Black or African American and of unknown/not reported ethnicity.:

White Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are White and of unknown/not reported ethnicity.:

More than One Race Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who identify with more than one racial category and of unknown/not reported ethnicity.:

Unknown Race Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender, unknown/not reported race, and unknown/not reported ethnicity.:

Total Unknown Ethnicity Unknown Sex: This field is auto-calculated to total all racial categories for individuals of unknown/not reported sex/gender and unknown/not reported ethnicity.:

UnknownEthnicityUnknownGenderisValid:

Total Unknown Race: This field is auto-calculated to total individuals of unknown/not reported race.:

Previous Report: Click to move to the previous report entry.:

CurrentPageNumber:

TotalPages_PHS_CIReport:

Next Report: Click to add or move to the next report entry.:

First Report: Click to move to the first report entry.:

Last Report: Click to move to the last report entry.:

Protection of Human Subjects:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance. :

Protection of Human Subjects - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance. :

Protection of Human Subjects - View Attachment: Click to view this attachment.:

Protection of Human Subjects - Delete Attachment: Click to delete this attachment.:

Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site - Yes: See agency-specific instructions for additional guidance.:

Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site - No: See agency-specific instructions for additional guidance.:

Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site - Not Applicable: See agency-specific instructions for additional guidance.:

Single IRB plan: See funding opportunity announcement and agency-specific instructions for additional guidance. If applicable, attach PDF formatted file.:

Single IRB plan - Add Attachment:

See funding opportunity announcement and agency-specific instructions for additional guidance. If applicable, attach PDF formatted file.:

Single IRB plan - Delete Attachment: Click to delete this attachment.:

Single IRB plan - View Attachment: Click to view this attachment.:

Data and Safety Monitoring Plan: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Data and Safety Monitoring Plan - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Data and Safety Monitoring Plan - View Attachment: Click to view this attachment.:

Data and Safety Monitoring Plan - Delete Attachment: Click to delete this attachment.:

Will a Data and Safety Monitoring Board be appointed for this study is required.:

Will a Data and Safety Monitoring Board be appointed for this study? - Yes: Select Yes if a Data and Safety Monitoring Board will be appointed for this study.:

Will a Data and Safety Monitoring Board be appointed for this study? - No: Select No if a Data and Safety Monitoring Board will not be appointed for this study.:

Overall Structure of the Study Team: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Overall Structure of the Study Team - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Overall Structure of the Study Team - View Attachment: Click to view this attachment.:

Overall Structure of the Study Team - Delete Attachment: Click to delete this attachment.:

Detailed Description: Enter the detailed description of the protocol. See agency-specific instructions for additional guidance.:

Primary Purpose: Select one.:

tabNext:

tabPrev:

Other Primary Purpose: Enter description. This field is required if Primary Purpose is Other.:

Intervention Type: Select one.:

Name: Enter the name of the intervention.:

Description: Enter a description of the intervention.:

Study Phase: Select one.:

Is this an NIH-defined Phase III clinical trial? - Yes: See agency-specific instructions for additional guidance.:

Is this an NIH-defined Phase III clinical trial? - No: See agency-specific instructions for additional guidance.:

Intervention Model: Select one.:

Other Intervention Model: Enter description. This field is required if Intervention Model is Other.:

Masking - Yes: See agency-specific instructions for additional guidance.:

Masking - No: See agency-specific instructions for additional guidance.:

Masking Type is required if Masking is Yes.:

Participant: Check to select. This field is required if Masking is Yes.:

Care Provider: Check to select. This field is required if Masking is Yes.:

Investigator: Check to select. This field is required if Masking is Yes.:

Outcomes Assessor: Check to select. This field is required if Masking is Yes.:

Allocation: Select one.:

Name: Enter the name of the individual outcome or measure.:

Type: Select one.:

Time Frame: Indicate when a measure will be collected for analysis.:

Description: Enter a brief description of the outcome or measure.:

Add New Outcome: Click to add another Outcomes or Measures entry.:

Statistical Design and Power: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Statistical Design and Power - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Statistical Design and Power - View Attachment: Click to view this attachment.:

Statistical Design and Power - Delete Attachment: Click to delete this attachment.:

Subject Participation Duration: Enter the time it will take for each individual participant to complete all study visits. See agency-specific instructions for additional guidance.:

FDARegulatedIntervention_Req:

Will the study use an FDA-regulated intervention? - Yes: See agency-specific instructions for additional guidance.:

Will the study use an FDA-regulated intervention? - No: See agency-specific instructions for additional guidance.:

If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status is required: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status - Add Attachment: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status - View Attachment: Click to view this attachment.:

If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status - Delete Attachment: Click to delete this attachment.:

Is this an applicable clinical trial under FDAAA? - Yes: See agency-specific instructions for additional guidance.:

Is this an applicable clinical trial under FDAAA? - No: See agency-specific instructions for additional guidance.:

Dissemination Plan: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Dissemination Plan - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Dissemination Plan - View Attachment: Click to view this attachment.:

Dissemination Plan - Delete Attachment: Click to delete this attachment.:

Other Clinical Trial-related Attachments - Add Attachments:

Attach up to 10 PDF formatted files. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Other Clinical Trial-related Attachments - Delete Attachments:

Other Clinical Trial-related Attachments - View Attachments:

Attachment Check Box: Indicates whether an Attachment is attached:

ObjList:

FNList:

AttCount:

Add:

Delete:

View:

Done:

goNext:

LastField:

D:20061130151358- 05'00' D:20061130151358- 05'00' PHS Human Subjects and Clinical Trials Information PHS Human Subjects and Clinical Trials Information OMB Number: 0925-0001 Expiration Date: 02/28/2023 Use of Human Specimens and/or Data

* Does any of the proposed research in the application involve human specimens and/or data?

Answer to the question "Does any of the proposed research in the application involve human specimens and/or data?" is required.

Does any of the proposed research in the application involve human specimens and/or data?: A response to this question is required.

Provide an explanation for any use of human specimens and/or data not considered to be human subjects research.

Please complete the human subjects section of the Research & Related Other Project Information form prior to completing this form.

The following items are taken from the Research & Related Other Project Information form and displayed here for your reference. Any changes to these fields must be made on the Research & Related Other Project Information form and may impact the data items you are required to complete on this form.

Are Human Subjects Involved?

Are Human Subjects Involved is required: Indicates whether activities involving human subjects are planned at some time during the proposed project.

Human Subject Involvement: Pre-populated from the Research & Related Other Project Information Form.

Indicates whether activities involving human subjects are planned at some time during the proposed project. This field is required.

Is the Project Exempt from Federal regulations?

Is the Project Exempt from Federal regulations is required: Indicates whether this project is exempt from Federal regulations.

Is the Project Exempt from Federal regulations Exemption number:

If No to Human Subjects Skip the rest of the PHS Human Subjects and Clinical Trials Information Form.

If Yes to Human Subjects Add a record for each proposed Human Subject Study by selecting ‘Add New Study’ or ‘Add New Delayed Onset Study’ as appropriate. Delayed onset studies are those for which there is no well-defined plan for human subject involvement at the time of submission, per agency policies on Delayed Onset Studies. For delayed onset studies, you will provide the study name and a justification for omission of human subjects study information.

Other Requested Information Study Record(s) Attach human subject study records using unique filenames.

When the Workspace feature is used to complete application packages, subforms are added and managed using online Workspace functionality. This Workspace variation of the Human Subject Study Attachment(s) form displays subform names as specified by the applicant.

Add a record for each proposed Human Subject Study by selecting ‘Add New Study’ or ‘Add New Delayed Onset Study’ as appropriate. Delayed onset studies are those for which there is no well-defined plan for human subject involvement at the time of submission, per agency policies on Delayed Onset Studies. For delayed onset studies, you will provide the study name and a justification for omission of human subjects study information.

Other Requested Information Study Record(s) Delayed Onset Study(ies) Study Title Anticipated Clinical Trial?

Justification Description: Provide a brief description of the item. This field is required for each row entered.

OMB Number: 0925-0001 Expiration Date: 02/28/2023 Study Record: PHS Human Subjects and Clinical Trials Information

* Always required field Section 1 - Basic Information

1.1. * Study Title (each study title must be unique)

1.2. * Is this Study Exempt from Federal Regulations?

1.3. Exemption Number

1.4. * Clinical Trial Questionnaire If the answers to all four questions below are yes, this study meets the definition of a Clinical Trial.

1.4.a. Does the study involve human participants?

1.4.b. Are the participants prospectively assigned to an intervention?

1.4.c. Is the study designed to evaluate the effect of the intervention on the participants?

1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

1.5. Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable Section 2 - Study Population Characteristics

2.1. Conditions or Focus of Study

2.2. Eligibility Criteria

2.3. Age Limits

Minimum Age Maximum Age 2.3.a. Inclusion of Individuals Across the Lifespan

2.4. Inclusion of Women, Minorities

2.5. Recruitment and Retention Plan

2.6. Recruitment Status

2.7. Study Timeline

2.8. Enrollment of First Participant

2.9. Inclusion Enrollment Report(s)

Inclusion Enrollment Report OMB Number: 0925-0001 Expiration Date: 02/28/2023

1. * Inclusion Enrollment Report Title

2. * Using an Existing Dataset or Resource

3. * Enrollment Location Type

4. Enrollment Country(ies)

5. Enrollment Location(s)

6. Comments Planned Racial Categories Ethnic Categories Not Hispanic or Latino Female Male Hispanic or Latino Female Male Total American Indian/ Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White More than One Race Total Cumulative (Actual) Racial Categories Ethnic Categories Not Hispanic or Latino Female Male Unknown/ Not Reported Hispanic or Latino Female Male Unknown/ Not Reported Unknown/Not Reported Ethnicity Female Male Unknown/ Not Reported Total American Indian/ Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White More than One Race Unknown or Not Reported Total Report of Section 3 - Protection and Monitoring Plans

3.1. Protection of Human Subjects

3.2. Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

Single IRB plan attachment

3.3. Data and Safety Monitoring Plan

3.4. Will a Data and Safety Monitoring Board be appointed for this study?

3.5. Overall Structure of the Study Team

Section 4 - Protocol Synopsis

4.1. Study Design

4.1.a. Detailed Description Narrative Study Description: Enter the narrative study description.

4.1.b. Primary Purpose 4.1.c. Interventions Intervention Type Name Description 4.1.d. Study Phase Is this an NIH-defined Phase III clinical trial?

4.1.e. Intervention Model 4.1.f. Masking 4.1.g. Allocation

4.1. Outcome Measures

Name Type Time Frame Brief Description

4.3 Statistical Design and Power

4.4. Subject Participation Duration

4.5. Will the study use an FDA-regulated intervention?

4.5.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status

4.6. Is this an applicable clinical trial under FDAAA?

4.6. Dissemination Plan

Section 5 - Other Clinical Trial-related Attachments

5.1. Other Clinical Trial-related Attachments

Are Human Subjects Involved - Yes: Indicates whether activities involving human subjects are planned at some time during the proposed project. This field is required.

Are Human Subjects Involved - No: Indicates whether activities involving human subjects are planned at some time during the proposed project. This field is required.

Human Subject Involvement:

Indicates whether activities involving human subjects are planned at some time during the proposed project. This field is required.

Is the Project Exempt from Federal regulations - Yes: Indicates whether this project is exempt from Federal regulations.

Is the Project Exempt from Federal regulations - No: Indicates whether this project is exempt from Federal regulations.

Is the Project Exempt from Federal regulations Exemption Number 1: If human subject activities are exempt from Federal regulations, provide the exemption numbers corresponding to one or more of the exemption categories.

Exemption Number 2: If human subject activities are exempt from Federal regulations, provide the exemption numbers corresponding to one or more of the exemption categories.

Exemption Number 3: If human subject activities are exempt from Federal regulations, provide the exemption numbers corresponding to one or more of the exemption categories.

Exemption Number 4: If human subject activities are exempt from Federal regulations, provide the exemption numbers corresponding to one or more of the exemption categories.

Exemption Number 5: If human subject activities are exempt from Federal regulations, provide the exemption numbers correspond to one or more of the exemption categories.

Exemption Number 6: If human subject activities are exempt from Federal regulations, provide the exemption numbers corresponding to one or more of the exemption categories.

Exemption Number 7: If human subject activities are exempt from Federal regulations, provide the exemption numbers corresponding to one or more of the exemption categories.

Exemption Number 8: If human subject activities are exempt from Federal regulations, provide the exemption numbers corresponding to one or more of the exemption categories.

1) Human Subject Study 1

Public reporting burden for this collection of information is estimated to average 4-14 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0001 and 0925-0002). Do not return the completed form to this address.:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.: