Form 6e Adult Amendment of Cooperative Group Protocol

N CI Adult CIRB

REVIEWER WORKSHEET

Amendment to Cooperative Group Protocol

Early Phase Emphasis Late Phase Emphasis

OMB#: 0925 – 0625

Expiry Date: 01/31/2014

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation in the NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any way. The information collected will be kept private to the extent provided by law. Names and other identifiers will not appear in any report of the NCI CIRB. Information provided will be combined for all participants and reported as summaries. You are being requested to complete this instrument so that we can conduct activities involved with the operations of NCI CIRB Initiative.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN

Public reporting burden for this collection of information is estimated to average 2 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 (0925-0625). Do not return the completed form to this address.

STUDY ID:      

STUDY TITLE:      

NAME OF CIRB REVIEWER:      

DATE COMPLETED:      

1. I have reviewed the following documents (check all that apply):

NCI Pediatric CIRB Application for Treatment Studies or NCI Adult/Pediatric CIRB Application for Ancillary Studies  

Summary of CIRB Application Revisions

Summary of Changes related to the Amendment

Study Protocol

Cooperative Group Model Informed Consent Document(s)

Other (specify):      

2. The amendment includes the following changes (check all that apply):

Increase or decrease in accrual (impacts statistical design)

Addition or deletion of a treatment group/arm

Addition or deletion of a study drug

Change in treatment period/treatment design

Changes in the informed consent document(s)

Editorial and/or administrative changes

Other:      

3. Please provide a brief summary of the current approved protocol. (Note to reviewer: Not applicable for amendments containing solely editorial and/or administrative changes)

     

4. Please provide the rationale for the amendment. (Note to reviewer: Not applicable for amendments containing solely editorial and/or administrative changes)

     

5. Do the changes in the amendment alter the risk/benefit ratio to the participants?

If Yes, explain whether the benefits continue to outweigh the risks.:      

No

If Uncertain, please explain:      

6. Do any of the changes in this amendment include significant new findings that might relate to the participant’s willingness to continue participation in the research?

If Yes, describe what plans are included to notify/re-consent participants and indicate whether the plans are sufficient.:      

If No, please explain:      

7. Please provide your comments and/or concerns regarding the amendment.

     

8. Please provide your recommendation for CIRB action on the amendment.

     

Accurate Per ePanel© 05/13/13