Form 33 CIRB Pharmacy Reviewer Form

Attachment 6I:

NCI CIRB
PHARMACY REVIEWER FORM

OMB#: 0925 – xxxx Expiry Date: xx/xx/xxxx
STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. While your participation is
completely voluntary, to participate in the NCI CIRB, completion of this form is required. Data
collected as part of the NCI CIRB review is private and protected by law. Under the provisions of
Section 301d of the Public Health Service Act, no information that could permit identification of a
participating individual may be released. All such information will be kept private under the
Privacy Act and will be presented only in statistical or summary form.
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-xxxx*). Do not
return the completed form to this address.

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NCI Pediatric CIRB
PHARMACY FINDINGS
FROM REVIEW OF COOPERATIVE GROUP PROTOCOL

GROUP STUDY NUMBER: pCIRB NUMBER:
STUDY TITLE:
PROTOCOL VERSION DATE:
Name of Reviewer:
Date Completed:
1. Does this protocol have scientific value regarding use of the proposed
investigational drugs?
? Are the background assumptions that lead to use of the study drug(s)
valid?
2. Does the research design minimize study drug risks to subjects?

3. How does the inclusion/exclusion of specific populations support/justify
the use of the investigational drug(s)?
? If a solid dosage form is being used, do the inclusion/exclusion criteria
address ability to swallow dosage form intact where no liquid is available?
? Is the age group being studied supported in the background?
4. Is the generic name (if available) of the drug used throughout protocol
and consent?
? Consent should list generic (abbreviation, brand name)
? Generic name should be used for all commercially available agents
? Abbreviations should only be used for schemas and charts where space
does not allow use of generic name
5. Is a package insert or investigator’s brochure provided for each agent
used on the protocol?

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6. Evaluate drug monograph for inclusion of the following areas. Use
investigator’s brochure or package insert to verify accuracy of information.
? Agent Stability
? Agent Preparation
? Agent Storage
? Agent Administration
? Adverse events
? Contraindications
? Warnings
? Drug/Herb/Food Interactions
? Neonatal dosing/adjustments for gestational age
7. Evaluate treatment plan.
? Dose delineated per dose and not per day/per course
? Adequate administration information
? Maximum number of courses for Phase I/II trials
? Premedication(s) described, if needed
? Patient monitoring described, if needed
? Dosing stratified if patients less than 1 year are included
? Laboratory monitoring is adequate for possible side effects
8. Is adequate information provided to order the investigational agent(s)?
? Are the appropriate forms provided or links to same?
? Is the vial/bottle size provided?
? Is the contact information provided for the vendor-providing agent? Are
hours of operation provided? Is the expected shipment turnaround time
included?
9. Does protocol address disposition of the investigational agent(s)?
? Should bottles/vials of agent be returned to site when patient off study?
? Should empty bottles/vials of agent be saved for return to sponsor?
? Should partial bottles/vials be saved for return to sponsor?
? What is the process for returning agent to sponsor? Are the appropriate
forms included in the protocol?
10. Does the dose modification section address all agents used in the
protocol?
? Is dosing for organ dysfunction included?
? Is dosing for obese patients included?
11. Assess the adequacy of the supportive care section
? Is PCP prevention therapy included if neutropenia is expected?
? Are the specific supportive care agents needed for drugs used in the study
included?
? Extravasation management

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12. Does the consent form include all relevant adverse events?
? All serious/life threatening events regardless of incidence
? All black box warnings
? All adverse events with an incidence > 5 %
? Are adverse events presented in appropriate lay language?
? Do these correspond to those listed in the protocol drug monograph?
13. Does consent advise on relevant drug/food/herb interactions?

14. Does consent properly list if agent(s) provided at no cost in financial
concerns?

15. Additional Remarks

Pediatric Risk Assessment
? Research/clinical investigations not involving greater than minimal risk.
Permission of at least one parent is required. (§ 46.404, § 50.51)
? Research/clinical investigations involving greater than minimal risk but
presenting the prospect of direct benefit to the individual subjects.
Permission of at least one parent is required. (§ 46.405, § 50. 52)
? Research/clinical investigations involving greater than minimal risk and no
prospect of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subject’s disorder or condition.
Permission of both parents is required. (§ 46.406, § 50.53)
? Research/clinical investigations not otherwise approvable which presents
an opportunity to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children. Specific approval is required
from the FDA Commissioner or DHHS Secretary. ( § 46.407, § 50.54)

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