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AH CLINICAL TRIALS

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Page 1 of 8
Instructions to the Applicant – please complete this application in ink and answer all questions completely.
Attach extra sheets as necessary should you run out of space provided. An incomplete or illegible application
cannot be processed. Completion of this application neither binds coverage nor guarantees that a policy will be
issued.
APPLICATION FOR CLINICAL TRIALS
Provide a fully completed application, signed and dated by the owner, partner, or officer not earlier than 45 days
before the proposed effective date of coverage.
If a question is not applicable, then state “N/A”.
The following information must be submitted with the completed application:
- Copy of your current professional liability insurance Declarations Page (claims made
policies must reflect the retroactive date)
- Copy of your Informed Consent documents
- Copy of all contracts between you and any Principal Investigators or trial sponsors
- Copy of your advertisements
- Copy of your current Financial Statement
- 5-year company loss runs, valued within the last 60 days
GENERAL INFORMATION
Applicant Name:____________________________________________________________________________________________
List of Any Previous Names or Organizations:_____________________________________________________________________
Date Established:____________________________ Website:_______________________________________________
Mailing Address:____________________________________________________________________________________________
Additional Locations: ________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
Applicant is: Corporation Partnership Joint Venture Not For Profit
Limited Liability Company Individual Other
Audit Contact: _______________________________ __ Phone Number: _________________________________________
Kinsale Insurance Company
P. O. Box 17008
Richmond, VA 23226
(804) 289-1300
www.kinsaleins.com
Page 2 of 8
Description of Operations:____________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
Revenues and Anticipated Number of Participants
Revenues Participants
Upcoming Year ________________ ________________
Current Year ________________ ________________
First Prior Year ________________ ________________
Second Prior Year ________________ ________________
Third Prior Year ________________ ________________
STAFFING
1. Please indicate the number of employed professionals or independent contractors
Staff: Full Time Part Time Contracted
Principal Investigator
Physician
RN/LPN
Research Associates
Research Monitors
Regulatory Compliance
Data Management
Other (specify)
Check the hiring procedures that apply or are performed:
Criminal Background Checks
Drug, alcohol and sexual abuse screening or testing
Verification of certification or professional licensing
Reference Checks
Questioning of employees in their previous involvement as defendants in professional malpractice litigation.
Page 3 of 8
2. Please list each Principal Investigator and Sub Investigator
NAME STATE LICENSE
AVERAGE
HOURS
WORKED PER
WEEK FOR THE
APPLICANT INDIVIDUAL INSURER & LIMITS
3. Do you require all of your Principal Investigators and Sub Investigators to carry their own professional
liability limits?
i. If yes, what are the minimum limits required? ______________________
ii. If no, are you requesting coverage for them under this policy?
iii. If yes, what are the minimum limits required? ______________________
iv. If no, are you requesting coverage for them under this policy?
Yes No
Yes No
Yes No
OPERATIONS
1. Do you manufacture or distribute any products?
Yes No
2. Do you sign a written contract with all trial sponsors? Yes No
3. Do you require a Certificate of Insurance providing proof of product liability coverage from each trial
sponsor?
Yes No
If yes, what are the minimum limits required? ________________
4. Do you require all subcontractors providing services in connection with your trial to carry their own
professional liability insurance coverage?
Yes No
If yes, what are the minimum limits required? ________________
5. Do you ever act as both the trial sponsor and clinical Investigator?
Yes No
6. Do you recruit or enroll your own study participants? Yes No
7. Are participants required to sign an informed consent document? Yes No
8. Do you enroll minors in your trials? Yes No
Page 4 of 8
9. Are all of your clinical trials approved and subject to oversight by an Institutional Review Board?
10. Do your investigators conduct trials in accordance with FDA approved protocols? Yes No
11. Please describe all health care services your employees provide (attach a separate sheet if necessary):
__________________________________________________________________________________________________________
__________________________________________________________________________________________________________
__________________________________________________________________________________________________________
12. Do you operate an in-patient facility?
Yes No
If yes, how many beds? ________________
13. Do you comply with the FDA Good Clinical Practice Guidelines?
i. Do you have written procedures in place to insure compliance with GCP’s?
ii. Have you ever been found not in compliance of GCP’s by any regulatory authority?
iii. Do you require that all personnel complete a formal training program on all policies and procedures
including GCP’s?
Yes No
Yes No
Yes No
Yes No
14. Are you accredited by any industry body or regulatory authority? If yes, please list.
__________________________________________________________________________________________
__________________________________________________________________________________________
Yes No
15. Are you a member of any industry trade organization? If yes, please list.
__________________________________________________________________________________________
__________________________________________________________________________________________
Yes No
CLINICAL TRIALS
1. Please indicate the percentage for the following:
i. Trial Phase:
Phase I - ________________
Phase II - ________________
Phase III - ________________
Phase IV - ________________
Other (describe) - ________________
____________________________
ii. Services provided for:
CRO - ________________
Manufacturer- ________________
Academic Medical Facility - ________________
Research Organization - ________________
Other (describe) - ________________
____________________________
iii. Product or Procedure:
Pharmaceuticals - ________________
Biologics - ________________
Medical Devices - ________________
Investigational Procedure - ________________
Other (describe) - ________________
____________________________
Page 5 of 8
iv. Trials:
Class III Medical Devices - _______________
Controlled Substances - _______________
Cosmetics - _______________
Diagnostic Instruments - _______________
Diet Aides - _______________
Dietary Supplements - _______________
Food - _______________
Hormones or Steroids - _______________
Implantable Devices - _______________
In-patient - _______________
Investigational Devices - _______________
Investigational New Drugs - _______________
Off-label Use - _______________
OTC - _______________
Prescription Drugs - _______________
Psychiatric Drugs - _______________
Surgical Equipment - _______________
Vaccines - _______________
Other (describe) - _______________
____________________________
2. Please list all active clinical trials. Please attach a separate sheet if additional space is needed.
Name
# of Subjects
Phase Location Length
Description
Name
# of Subjects
Phase Location Length
Description
Name
# of Subjects
Phase Location Length
Description
Name
# of Subjects
Phase Location Length
Description
Name
# of Subjects
Phase Location Length
Description
Name
# of Subjects
Phase Location Length
Description
Page 6 of 8
LOSS HISTORY
1. How many adverse events have been reported to you, the FDA and/or any other regulatory authority concerning your clinical
trials in the last 5 years? Please provide details. ___________________________________________________________________
__________________________________________________________________________________________________________
__________________________________________________________________________________________________________
2. Has any claim been made against any person or organization proposed for this insurance during the last five
(5) years?
Yes No
If yes, please provide five (5) year loss history for all claims, including any predecessor. Attach a description of any loss
greater than $10,000.
Year No. of Claims Total Amounts Paid Amounts Reserved Total Incurred Date of Loss Info.
3. Is any person or organization proposed for this insurance aware of any fact, incident, circumstance,
situation, condition, defect or suspected defect which may result in a claim, such that would fall under the
proposed insurance?
Yes No
If yes, please provide details. __________________________________________________________________________________
__________________________________________________________________________________________________________
INSURANCE INFORMATION
1. Has any insurer declined, canceled, or nonrenewed any General Liability, Professional Liability or similar
insurance on behalf of any person or organization proposed for this insurance?
Yes No
If yes, please provide details. __________________________________________________________________________________
2. Provide the following insurance information for the prior five (5) years:
Year Limits of Liability Deductible/SIR Premium Effective Dates Retroactive Date
3. Indicate the limits of liability and deductible requested:
i. General Liability Limits - $__________________/$_________________ Deductible - $______________
ii. Professional Liability Limits - $__________________/$_________________ Deductible -$______________
Page 7 of 8
FRAUD WARNING
NOTICE TO ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, CONNECTICUT, DELAWARE, GEORGIA, IDAHO, ILLINOIS, INDIANA,
IOWA, KANSAS, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEVADA,
NEW HAMPSHIRE, NORTH CAROLINA, NORTH DAKOTA, OREGON, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TEXAS, UTAH,
VERMONT, WASHINGTON, WEST VIRGINIA, WISCONSIN, AND WYOMING APPLICANTS: In some states, any person who knowingly, and
with intent to defraud any insurance company or other person, files an application for insurance or statement of claim containing any
materially false information, or, for the purpose of misleading, conceals information concerning any fact material thereto, may commit a
fraudulent insurance act which is a crime in many states.
NOTICE TO COLORADO APPLICANTS: It is unlawful to knowingly provide false, incomplete or misleading facts or information to an
insurance company for the purpose of defrauding or attempting to defraud the company. Penalties may include imprisonment, fines,
denial of insurance and civil damages. Any insurance company or agent of an insurance company who knowingly provides false,
incomplete or misleading facts or information to a policy holder or claimant for the purpose of defrauding or attempting to defraud the
policyholder or claiming with regard to a settlement or award payable for insurance proceeds shall be reported to the Colorado Division
of Insurance within the Department of Regulatory Agencies.
NOTICE TO DISTRICT OF COLUMBIA APPLICANTS: WARNING: It is a crime to provide false or misleading information to an insurer for
the purpose of defrauding the insurer or any other person. Penalties include imprisonment and/or fines. In addition, an insurer may deny
insurance benefits if false information materially related to a claim was provided by the applicant.
NOTICE TO FLORIDA APPLICANTS: Any person who knowingly and with intent to injure, defraud or deceive any insurance company files
a statement of claim containing any false, incomplete or misleading information is guilty of a felony of the third degree.
NOTICE TO HAWAII APPLICANTS: For your protection, Hawaii law requires you to be informed that presenting a fraudulent claim for
payment of a loss or benefit is a crime punishable by fines or imprisonment, or both.
NOTICE TO KENTUCKY APPLICANTS: Any person who knowingly and with intent to defraud any insurance company or other person files
an application for insurance containing any materially false information or conceals, for the purpose of misleading, information
concerning any fact material thereto commits a fraudulent insurance act, which is a crime.
NOTICE TO LOUISIANA APPLICANTS: Any person who knowingly presents a false or fraudulent claim for payment of a loss or benefit or
knowingly presents false information in an application for insurance is guilty of a crime and may be subject to fines and confinement in
prison.
NOTICE TO MAINE APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company
for the purpose of defrauding the company. Penalties may include imprisonment, fines, or denial of insurance benefits.
NOTICE TO NEW JERSEY APPLICANTS: Any person who includes any false or misleading information on an application for an insurance
policy is subject to criminal and civil penalties.
NOTICE TO NEW MEXICO APPLICANTS: Any person who knowingly presents a false or fraudulent claim for payment of a loss or benefit
or knowingly presents false information in an application for insurance is guilty of a crime and may be subject to civil fines and criminal
penalties.
NOTICE TO NEW YORK APPLICANTS: Any person who knowingly and with intent to defraud an insurance company or other person files
an application for insurance or statement of claim containing any materially false information, or conceals, for the purpose of misleading,
information concerning any fact material thereto, commits a fraudulent insurance act, which is a crime and shall also be subject to a civil
penalty not to exceed $5,000 and the stated value of the claim for each such violation.
NOTICE TO OHIO APPLICANTS: Any person who, with intent to defraud or knowing that he/she is facilitating a fraud against an insurer,
submits an application or files a claim containing a false or deceptive statement is guilty of insurance fraud.
NOTICE TO OKLAHOMA APPLICANTS: WARNING: Any person who knowingly, and with intent to injure, defraud or deceive any insurer,
makes a any claim for the proceeds of an insurance policy containing any false, incomplete or misleading information is guilty of a felony.
Page 8 of 8
NOTICE TO PENNSYLVANIA APPLICANTS: Any person who knowingly and with intent to defraud any insurance company, or other
person, files an application for insurance or statement of a claim containing any materially false information or conceals for the purpose
of misleading, information concerning any fact material thereto commits a fraudulent insurance act, which is a crime and subjects the
person to criminal and civil penalties.
NOTICE TO TENNESSEE APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance
company for the purpose of defrauding the company. Penalties include imprisonment, fines and denial of insurance benefits.
NOTICE TO VIRGINIA APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance
company for the purpose of defrauding the company. Penalties include imprisonment, fines and denial of insurance benefits.
The Applicant acknowledges that the answers provided herein are based on a reasonable inquiry and/or investigation. The Applicant
warrants that the above statements and particulars together with any attached or appended documents are true and complete and do
not misrepresent, misstate or omit any material facts.
The Applicant agrees to notify us of any material changes in the answers to the questions on this questionnaire which may arise prior
to the effective date of any policy issued pursuant to this questionnaire and the Applicant understands that any outstanding
quotations may be modified or withdrawn based upon such changes at our sole discretion.
Completion of this form does not bind coverage. Applicant’s acceptance of the company’s quotation is required prior to binding
coverage and policy issuance.
All written statements and materials furnished to the company in conjunction with this application are hereby incorporated by
reference into this application and made a part of this application.
Applicant: _____________________________________ Title: ________________________________
FEIN #: _____________________________________
Applicant’s Signature: ___________________________ Date: ________________________________
Agent / Broker Name: _____________________________________________________________________
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AH CLINICAL TRIALS

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Completed 2 July 2020

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