Form 6C Adult Continuing Review of Cooperative Group Protocol RE

N CI ADULT CIRB

REVIEWER WORKSHEET

Continuing Review of Cooperative Group Protocol

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 National Cancer Institute (NCI) Central Institutional Review Board (CIRB) Initiative is protected by The Privacy Act of 1974, as amended. The purpose of the information collection is to conduct reviews of clinical trial studies. Although your participation in NCI-sponsored research and completion of the forms is voluntary, if you wish to participate in the CIRB, you must complete all questions on the form. The information you provide will be combined for all participants and reported as summaries. It will be kept private to the extent provided by law.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN

Public reporting burden for this collection of information is estimated to average 1 hour 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:      

PROTOCOL VERSION DATE:      

NAME OF CIRB REVIEWER:      

DATE COMPLETED:      

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

NCI Adult/Pediatric CIRB Application for Continuing Review

Study Protocol

Cooperative Group Model Informed Consent Document(s)

CIRB Approved Informed Consent Document(s)

DSMB/Safety Monitoring Committee Report

Presentations or publications for the study

Relevant information relating to participants’ risks and benefits

Management plan to address new or revised conflicts of interest

Other (specify):      

2. Are there any important changes in the risks, benefits, or protocol schedule that you believe have an impact on the CIRB's approval of this protocol?

Yes, please explain:      

No

3. In your judgment, do the benefits of this study continue to outweigh the risks?

Yes, please explain:      

No, explain:      

Uncertain, explain:      

4. Do you recommend that the CIRB approve continuation of this study?

Yes

No, explain:      

Uncertain, explain:      

5. Additional Remarks.

Adapted from ePanel© 05/10/13