18 HSCT Sections 1-6

PHS Applications and Pre-award Related Reporting (OD)

Attachment 5F PHS Human Subjects and Clinical Trial Information - Sections 1-6_Includes Inclusion Enrollment Report_FORMS-F-js e

Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)

OMB: 0925-0001

Document [pdf]
Download: pdf | pdf
Study Record: PHS Human Subjects and Clinical Trials Information
OMB Number: 0925-0001 and 0925-0002
Expiration Date: 03/31/2020
• 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? D Yes

D No

01 02 03 04 05 06 07

1.3 Exemption Number

08

1.4 *Clinical Trial Questionnaire
If the answers to all four questions are yes, this study meets the definition of a Clinical Trial.
1.4.a. Does the study involve human participants?

D Yes

D No

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

D Yes

D No

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

□ Yes

□ No

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

D Yes

D No

1.5 Provide the Clinical Trials.gov Identifier (eg. NCT87654321) for this trial, if applicable

Section 2 - Study Population Characteristics
C::::�s_t_u_d_y
_________________________________________

2.2 Eligibility Criteria

2.3 Age Limits

..l

Minimum Age

2.3.a. Inclusion of Individuals Across the Lifespan

Maximim Age

Add Attachment

2.4 Inclusion of Women and Minorities

Add Attachment

2.5 Recruitment and Retention Plan

Add Attachment

II
II
II

Delete Attachment

Delete Attachment
Delete Attachment

II
II
II

View Attachment

] [

View Attachment

View Attachment

View Attachment

2.6. Recruitment Status
2.7. Study Timeline

Add Attachment

2.8. Enrollment of First Participant
2.9. Inclusion Enrollment Report(s)

[ Add Inclusion Enrollment Report ]

Inclusion Enrollment Report
1. • Inclusion Enrollment Report Title
2. • Using an Existing Dataset or Resource

OYes

ONo

3. • Enrollment Location Tvoe

D Domestic

D Foreian

] [

Delete Attachment


File Typeapplication/pdf
File TitleAxure Document
Authorromanl
File Modified2019-12-30
File Created2019-12-23

© 2024 OMB.report | Privacy Policy