18 PHS Human Subjects and Clinical Trial Information - Sect

PHS Applications and Pre-award Related Reporting (OD)

Attachment 5F PHS Human Subjects and Clinical Trial Information - Sections 1-5

398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)

OMB: 0925-0001

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HumanSubjectStudyForm

PHS Human Subjects and Clinical Trials Information
* Always required field

1. * Study Title (must be unique):
 2. * Delayed Onset Study?:

Yes

No

 3. * Is the Study Exempt from Federal Regulations?:

Yes

No

 4. * Exemption Number:

 

5. * Clinical Trial Questionnaire:
5.a. Does the study involve human participants?

Yes

No

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

Yes

No

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

Yes

No

5.d. Is the effect that will be evaluated a health­related, biomedical, or behavioral outcome?

Yes

No

If study is not delayed onset, the following sections are required:

Section 1 ­ Study Population Characteristics
1.1. Conditions or Focus of Study:
Add New Condition
1.2. Inclusion Criteria:
1.3. Exclusion Criteria:
1.4. Age Limits:

Minimum Age:

Maximum Age:

 

1.5. Inclusion of Women, Minorities and Children:

Add Attachment

1.6. Recruitment and Retention Plan:

Add Attachment

1.7. Recruitment Status:

 

 

1.8. Study Timeline:

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Inclusion Enrollment Report(s):

Add New IER Report

1

2

3

4

5

... 12

Entry #

Enrollment Location Type

Enrollment Location

1

Domestic

Enrollment Location 1

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2

Foreign

Enrollment Location 2

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3

Domestic

Enrollment Location 3

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4

Domestic

Enrollment Location 4

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5

Domestic

Enrollment Location 5

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Section 2 ­ Protection and Monitoring Plans
2.1. Protection of Human Subjects:

Add Attachment

2.2. Is this a multi­site study that will use the same protocol to conduct non­exempt human subjects research at more than one domestic site?

Yes

No

 If yes, describe the single IRB plan:

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2.3. Will a data and safety monitoring board be appointed for this study?

2.4. Data and Safety Monitoring Plan:

Yes

MonitoringPlan.pdf

No

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2.5. Overall structure of the study team:

Section 3 ­ Clinical Trial Synopsis
3.1. Objective:

3.2. Study Design:
3.2.a. Narrative Study Description:

3.2.b. Primary Purpose:

  

3.2.c. Interventions:

Intervention Type

 

Name
Description

Add New Intervention
3.2.d. Study Phase:

 
Is this an NIH­defined Phase III clinical trial? 

3.2.e. Intervention Model:

No

 

3.2.f. Masking:

Participant

Care Provider

Outcomes Assessor
3.2.g. Allocation:

Yes

Investigator
No Masking

  

3.3. Outcomes or Measures:
Name
Type

 

Time Frame

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Brief Description
Add New Outcome

3.4. Statistical Design and Power:

Add Attachment

3.5. Subject Participation Duration:
3.6. Will use an FDA regulated intervention?:

Yes

No

3.6.a. If yes, Availability of Investigational Product (IP) and IND/IDE Status:

3.7. Dissemination Plan :

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Section 4 ­ Other Clinical Trial­related Attachments

4.1. Other Trial Related Attachments:

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Attachment File Name

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Attachment

 Attachment 1.pdf

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 Attachment 2.pdf

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Section 5 ­ Clinical Trial Milestone Plan
5.1. Have there been any anticipated or unanticipated serious adverse events?

Yes

No

Not applicable

5.2. Have adverse events occurred with greater than 5 percent frequency
        within any area of the clinical trial?

Yes

No

Not applicable

5.3. Study Start Date:

MM/DD/YYYY

 

5.4. Study Primary Completion Date:

MM/DD/YYYY

 

5.5. Study Final Completion Date:

MM/DD/YYYY

 

5.6. Finalization of clinical protocol (with program agreement, if applicable):

MM/DD/YYYY

 

5.7. Registration of clinical trial in ClinicalTrials.gov:

MM/DD/YYYY

 

5.8. Completion of regulatory approvals:

MM/DD/YYYY

 

5.9. Enrollment of the first subject:

MM/DD/YYYY

 

25% of planned enrollment recruited by:

MM/DD/YYYY

 

50% of planned enrollment recruited by:

MM/DD/YYYY

 

75% of planned enrollment recruited by:

MM/DD/YYYY

 

100% of planned enrollment recruited by:

MM/DD/YYYY

 

5.10. Enrollment and randomization:

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5.11. Completion of data collection time period:

MM/DD/YYYY

 

5.12. Completion of primary endpoint data analyses:

MM/DD/YYYY

 

5.13. Completion of secondary endpoint data analyses:

MM/DD/YYYY

 

5.14. Completion of final study report:

MM/DD/YYYY

 

5.15. Reporting of results in ClinicalTrials.gov:

MM/DD/YYYY

 

5.16. Provide the ClinicalTrials.gov identifier (e.g. NCT00654321) for this trial :
5.17. Is this an applicable clinical trial under FDAAA?

Yes

No

5.18. Clinical Trials Registration & Reporting Certification:
Assurance is hereby provided that the recipient and all investigators conducting NIH­funded clinical trials are in compliance with NIH
policy on Dissemination of NIH­Funded Clinical Trial Information and that any clinical trial funded in whole or in part under this award
has been registered in ClinicalTrials.gov. If not registered at the time of this submission, the clinical trial will be registered not later than
21 days after enrollment of the first participant. Summary results have been submitted to ClinicalTrials.gov or will be submitted not
later than one year after the primary completion date, even if the primary completion date occurs after the period of performance.

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