Form 2 Pediatric Pharmacist's Review of a Cooperative Group Stu

N CI Pediatric CIRB

REVIEWER WORKSHEET

Pharmacist Review of Cooperative Group Study

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. Are the background assumptions that led to use of the study drug(s) valid?

Yes, describe how:      

No, explain why:      

2. Is the intervention designed to minimize risks to study participants? (Consider as appropriate: dosage, supportive care, administration and instructions if self-administered)

Yes, describe how:      

No, explain why:      

3. Are the inclusion/exclusion criteria appropriate for the intervention?

Yes, describe how:      

No, explain why:      

4. Has an Investigator’s Brochure been provided for each investigational agent used in the study?

Yes

No, (If no, the CIRB Operations Office will obtain it. Please provide agent name to staff.)

Not Applicable

5. Comments related to Question 4, if any:      

6. Is the pharmaceutical information provided in the protocol current and accurate? (Including, but not limited to; preparation, administration, contraindications, warnings, drug/food interactions, storage, instructions if self-administered, etc.)

Yes, describe how:      

No, explain why:      

7. Is the dose modification section appropriate and clearly written?

Yes, describe how:      

No, explain why:      

8. Will information be provided to study participants pertaining to drug/food interactions and/or instructions for self-administration for any protocol-specific interventions?

Yes, describe how:      

No (indicate what information the Study Chair should be requested to provide)

Not Applicable

9. Comments related to Question 8, if any:      

10. Does the informed consent document accurately describe the study intervention?

Yes

No, explain why:      

11. Comments related to Question 10, if any:      

12. Does the informed consent document include the reasonably foreseeable risks related to the intervention?

Yes

No, explain why:      

13. Comments related to Question 12, if any:      

14. Is the frequency of risks related to the intervention categorized appropriately? (likely, less likely or rare but serious)

Yes

No, explain why:      

15. Comments related to Question 14, if any:      

16. Additional Comments:      

Extracted from ePanel© 05/13/13