YALE UNIVERSITY
HUMAN INVESTIGATION COMMITTEE
Application for Expanded Access Programs (EAP’s)
600 FR 3 (2012-1)
HIC OFFICE USE ONLY
Submit this form, a copy of this form, two
copies of the consent form and a copy of
the sponsor’s clinical brochure, protocol, or
other pertinent informational materials,
patient information booklet—from the
sponsor( if applicable)
Investigator Brochure (if available)
DATE STAMPED-RECEIVED
PROTOCOL NUMBER
SECTION I: ADMINISTRATIVE INFORMATION
Title of Project or Protocol:
Principal Investigator:
Yale Academic Appointment:
Campus Address:
Campus Phone:
Fax:
Pager:
Protocol Correspondent Name & Address (if different than PI):
E-mail:
Campus Phone:
Fax:
E-mail:
Yale Cancer Center CTO Protocol Correspondent Name & Address (if applicable):
Campus Phone:
Fax:
E-mail:
SECTION II: GENERAL INFORMATION
1. Performing Organizations: Identify the hospital, in-patient or outpatient facility, school or
other agency that will serve as the location of the research. Choose all that apply:
a. Internal Location[s] of the Study:
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YCCI/Hospital Research Unit (HRU)
Cancer Center/Smilow
Yale-New Haven Hospital
Specify Other Yale Location:
2.
Area of Research:
Clinical Research: Patient-Oriented
3. Probable Duration of Project: State the expected duration of the project, including all
follow-up and data analysis activities.
SECTION V: PROTOCOL PLAN
4. Expanded Access Programs: (Check appropriate type)
Expanded access refers to the use of an investigational drug outside of a clinical trial by patients
with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical
trial in progress. This type of access may be available, in accordance with United States Food
and Drug Administration (FDA) regulations, when it is clear that patients may benefit from the
treatment, the therapy can be given safely outside the clinical trial setting, no other alternative
therapy is available, and the drug developer agrees to provide access to the drug. The FDA refers
to such a program as an expanded access program (EAP).EAPs can be leveraged in a wide range
of therapeutic areas.( including HIV/AIDS and other infectious diseases, cancer, rare diseases,
and cardiovascular diseases, to name a few.)
Single patient Expanded Access IND 21 CFR 312.310
The FDA may permit an Investigational drug to used for the treatment of serious and lifethreatening illnesses for which there are no satisfactory alternative treatments.
Expanded Access IND -Intermediate size patient population (~10 to 100) 21 CFR 312.315
When the FDA receives a significant number of requests for individual patient expanded access
to an investigational drug for the same use, they may ask the trial sponsor to consolidate these
requests, creating an intermediate-size group.
Expanded Access Treatment IND or Treatment protocol 21 CFR 312.320
The investigational drug will be used for widespread treatment use.
The FDA guidelines for IND submission are listed below:
Single patient IND
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http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/
ApprovalApplications/InvestigationalNewDrugINDApplication/ucm107434.htm
5. Summarize Treatment: The summary should contain a clear statement of the rationale and
hypothesis of your treatment use, a concise description of the methodology, and a discussion
of the results. The length should be at least one half of a page and no more than one page. (It
is acceptable to attach the summary provided to the FDA.)
Purpose of the treatment
Procedures performed in the treatment
Proposed length of time of the treatment
Risks to patients
Benefits to patients
6. Patient characteristics (Describe the eligibility criteria, usual treatment history for a patient
who would qualify for use of the investigational agent , the reason use of the investigational
agent is worth the risk to the patient(s) at this time.
7. Consent (Describe the process of consent for the treatment use of the investigational agent
procedure: personnel obtaining consent, assessment of the patient’s capacity to consent,
conditions under which consent will be obtained, any steps to minimize undue influence and
any steps to enhance the patient’s independent decision-making, such as a waiting period. If
non-English-speaking patients are to receive the investigational agent, describe provisions in
place to assure comprehension. If the patient is a minor, describe how parental or guardian
permission will be obtained)
Consent form: Sponsor may have consent form template or use Emergency/Expanded Access use
template from HRPP website:
http://www.yale.edu/hrpp/resources/docs/emergency_use_ICD_1-29-09_Final.doc
Please remember to remove references to devices.
8. Unanticipated Problems Involving Risk to Patients or Others:
NOTE: The following unanticipated problems must be reported to the HIC within 48 hours
of becoming known to the physician:
a. Problems or events that are unexpected (in terms of nature, severity, or frequency) given the
known investigational agent risks and the characteristics of the patient population;
b. Problems or events that suggest that the investigational agent places the patient at greater risk
or harm (including physical, psychological, economic, or social harm) than was previously
known or recognized; and
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c. Problems or events that are related or possibly related to the patient’s receipt of the
Investigational agent.
(Describe who will be responsible for monitoring patient safety and reporting unanticipated
problems.)
9. Financial Considerations: Will the patient incur any financial obligation as a result of
receiving this investigational agent?
10. Enclosures: (The following materials must be submitted with the application)
Sponsor’s Clinical brochure, protocol, or other pertinent informational materials
Patient information booklet—from the Sponsor( if applicable)
Investigator Brochure ( if available)
SECTION III: TEAM MEMBERS AND TRAINING
Team: List any members of the team that will be involved with the use of the investigational agent. Indicate
under the affiliation column whether the investigators or study personnel are part of the Yale faculty or staff,..
ALL members of the team MUST complete Human Subject Protection Training (HSPT) and Health
Insurance Portability and Accountability Act (HIPAA) Training before they may be listed on the protocol.
NOTE: The HIC will remove from the protocol any personnel who have not completed required training.
A personnel protocol amendment will need to be submitted when training is completed.
Name
Affiliation: Yale/Other
Institution (Identify)
NetID
Principal Investigator
Role:
Role:
Role:
Role:
Role:
Role:
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SECTION IV:
PRINCIPAL INVESTIGATOR/ AGREEMENT
As the principal investigator of this project, I certify that:
 The information provided in this application is complete and accurate.
 I assume full responsibility for the protection of patients and the proper conduct of the
project.
 Patient safety will be of paramount concern, and every effort will be made to protect subjects’
rights and welfare.
 The intervention will be performed according to ethical principles and in compliance with all
federal, state and local laws, as well as institutional regulations and policies regarding the
protection of patients.
 All members of the team will be kept apprised of goals.
 I will obtain approval for this project and any subsequent revisions prior to my initiating the
study or any change and I will obtain continuing approval of this study prior to the expiration date
of any approval period.
 I will report to the HIC any serious injuries and/or other unanticipated problems involving risk to
patients .
 I am in compliance with the requirements set by the University and qualify to serve as the
principal investigator of this project...
 I will identify a qualified successor should I cease my role as principal investigator and facilitate a
smooth transfer of investigator responsibilities.
_____
PI Name (PRINT) and Signature
Date
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