Amendment Information

1*Has subject accrual started at CSMC?
Yes

2Total Number of Subjects Enrolled To Date (for studieslimited to onlyspecimen/data analysis, give the # of subjects represented in the specimens/data analyzed to date):
[m1]12

3Total Number Subjects Who Have Completed the Study (for studies limited to only specimen/data analysis, ignore this question):

4Total Number of Subjects Who Have Withdrawn [m2]From Participation (for studies limited to onlyspecimen/data analysis, ignore this question):
3

5Number of Subjects Currently Undergoing Research Interventions (for studies limited to only specimen/data analysis, ignore this question):
9

6*Is the study open for continuing enrollment at CSMC?
Yes

7 *Are subjects currently undergoing research interventions at CSMC?
Yes

8*Please check all items that apply to indicate to which areas you are proposing changes with this amendment application ((Move current help text here) Please make necessary revisions to the study application and consent documents to reflect the proposed changes to the study):

Amendment Type

/ Changes in Personnel (Please revise Item #5 and/or Item #6 on Page, Study Identification Information)

/ Potential conflicts of interest of one or more study investigators (Please revise Pages Financial Conflicts of Interest and Describing Your Financial Interest in the Research)

/ Sample size at CSMC only (Please revise Item #2 on Page Sample Size Information)

/ Overall sample size at all sites (Please revise Item #2 on Page Sample Size Information)

/ Participation of Non-CSMC sites (Please revise page Non-CSMC Sites)

/ Process by which participants are identified and recruited (Please revise Page Study Population Checklist and/or Page Patient Identification and Recruitment)

/ Recruitment documents (Please revise Item #1 on Page Recruitment and Payment for Participation)

/ Informed consent or assent form(s) (Please revise Item #6 on Page Process of Informed Consent)

/ Protocol, including modifications to study procedures (Please upload a revised protocol in Item #3, on Page Study Background and Protocol)

/ Changes to Inclusion/Exclusion criteria (Please revise Page Inclusion and Exclusion Criteria)

/ Revisions to Data and Safety Monitoring Plan (Please revise Pages Data and Safety Monitoring Plan and Independent Monitor or DSMB)

/ Drug or device brochure (Please revise Page Use of Investigational Drugs or Biologics, Item #6, or Item #2 page, IND Application Requirement, or Item #3, Use of Medical Devices)

/ Procedures that involve exposure to radiation (Please revise Page Radiation Safety Information and/or Procedures Involving Exposure to Radiation)

/ Notification of intent to request funding/support from GCRC (Please revise Item #10 on Page Study Identification Information)

/ Modification to a protocol approved by the NCI C-IRB

/ Change in Principal Investigator (Change Item#3, Page Study Identification Information)

/ Changes to GCRC Services ONLY (changes only on the GCRC services pages, no changes to the IRB application)

/ Other

Please note that changes in personnel or the protocol proceduresmay also require you to update your Informed Consent or assent form(s).

9 *Please provide abrief description of the changes you are proposing with this amendment application:

Change to study procedures, personnel changes
10Please upload any documents (e.g., sponsor's memo regarding new information, etc.) that supportthis amendment:

name / version
Amended Protocol 3-18-2011

Confirmation of Change in Principal Investigator

Enter the date that the Office of Sponsored Research (SRFA) accepted the proposed change in Principal Investigator (PI):

Upload:

  1. Email or other documentation reflecting that the newly selected investigator has accepted the PI role.
  2. If this study is externally funded, upload an Eemail from SRFA reflecting that the proposed change in PI has been accepted.

name / version
There are no items to display

New Information

1*Please describe theproposed changes AND reason(s) for the changes you are proposing. Your response should clearly identify what prompted the amendment, e.g., “The release of IB Version 2 required updates to the description of the risk of fainting. Language was added to reflect fainting has occurred in 10 subjects who have given blood.”:

2 *Do the proposed changes require changes to the study consent form, includingdesciption description of additional risks of participation?
Yes No

3 *Does the nature of the proposed changes require that currently enrolled subjectsbe re-consented?
Yes No

Describe your plan to re-consent previously enrolled subjects:

4 *Do previously enrolled subjects who have completed study interventions need to be notified of new information regarding subject safety or welfare?
Yes No

Describe your plan to notify subjects who have completed study interventions of the new information:

[m1]

Hide/Show—Activate questions #2-4 based on #1. If activated, these questions will now be required.

NEW HELP TEXT:

The number of completed, withdrawn, and current subjects, as reported under Items #3, 4, 5, must total to the number of subjects enrolled to date, as reported under #2.

[m2]

Current text: Accrual refers to any individual who has been exposed to a research-related procedure. "Subjects accrued" should include any individual who has failed screening or has withdrawn before completing participation.