Initial Device Study Application

Initial Device Study Application

(Single Site Study)

SECTION 1: GENERAL STUDY INFORMATION
Sponsor: / Protocol Number:
Protocol Title:
SECTION 2: PRINCIPAL INVESTIGATOR CONTACT INFORMATION
Principal Investigator (PI) Name:
Site Name:
Address:
City: / State: / Zip Code:
Mailing Address: / Same as above
Address:
City: / State: / Zip Code:
PI Phone Number: / PI Email: / @
Main Phone Number to be listed in Informed Consent Document:
After Hours Number to be listed in Informed Consent Document:
Please Note: These numbers are required information.
Additional Addresses where the Research will be Conducted / None
Site Name #1:
Address:
City: / State: / Zip Code:
Would you like this location listed on your consent document(s)? / Yes No
Site Name #2:
Address:
City: / State: / Zip Code:
Would you like this location listed on your consent document(s)? / Yes No
Site Name #3:
Address:
City: / State: / Zip Code:
Would you like this location listed on your consent document(s)? / Yes No
If you have more locations than this space allows, please attach a list of names and addresses of all additional locations
SECTION 3: TEST ARTICLE INFORMATION
a. / Test Article Name:
b. / Please indicate which categorythe proposed use of this product fits into:
This protocol will be conducted under an IDE #– please note the following instructions: / IDE #:
Please support your IDE # by submitting one of the following: (1) the Sponsor protocol with the IDE # on it; (2) a letter from the Sponsor; (3) a letter from the FDA.
The protocol meets the abbreviated IDE requirements / NSR device as per 21 CFR 812.2(a)*
* please attach a letter from the Sponsor (on letterhead) stating why this device is classified as Non-Significant Risk in accordance with 21 CFR 812.3(m).
The device does not require an IDE from the FDA under the following category:
Approved device used as labeled [PMA, 510(k) Class I exemption] – please provide supporting documentation
Diagnostic Device as defined in 21 CFR 812.2(c)(3)
Consumer Preference Testing as defined in 21 CFR 812.2(c)(4)
Custom Device as per 21 CFR 812.2(c)(7)
c. / Does the device involve the use of ionizing radiation or isotopes? / No / Yes
d. / Will the Sponsor be charging the Principal Investigator and/or subjects for the device?
No / Yes – please attach a rationale and a description of the amount to be charged to PIs and/or subjects.
SECTION 4: SITE CONTACT INFORMATION
a. / Study Site Contact* / Email: / @
* Person who will be IRB contact throughout study duration
Phone: / FAX:
b. / List individuals who will need access to the web portal (attach additional sheet if necessary)
Name: / Email: / @
Name: / Email: / @
Name: / Email: / @
SECTION 5: SPONSOR INFORMATION
Contact Person:
Company:
Address:
City: / State: / Zip Code:
Phone: / FAX: / Email: / @
SECTION 6: IRB REVIEW INFORMATION
Has this protocol ever been submitted to another IRB for review?
No / Yes – list name of the IRB(s) and the outcome of the review(s) on a separate page.
SECTION 7: PRINCIPAL INVESTIGATOR
If supporting documentation has been previously submitted to Aspire IRB, there is no need to re-submit. Simply check “On File”. However, changes or new information must be submitted to Aspire IRB in a timely manner.
a. / Please provide a copy of the PI’s signed and dated CV (current within 2 years) / On File
b. / PI Specialty(ies):
Board Certified? / Yes – please describe / No
c. / Medical License (attach copy) / Expiration Date: / On File N/A
d. / DEA Registration (attach copy if applicable to this study) / Expiration Date: / On File N/A
e. / Has the PI ever been issued any of the following:

At any time in the past:

Conviction of a crime
FDA Warning Letter
NIDPOE (Notice of Initiation of Disqualification Proceedings and Opportunity to Explain)
Suspension or termination by an IRB
Suspension by a federal or government agency (such as FDA, HHS, or Health Canada)
OHRP Determination letter, Health Canada Inspection Letter or similar

Within the past five years

Form FDA 483

Clinical privileges at any site
DEA licensure
Fellowship/board certification
Medical licensure in any state, nation or province
Membership on any hospital staff
Prescribing privileges
Professional sanctions including fines and public reprimands
Professional society membership
Research privileges at any site

No *Yes – provide explanation
*Are all related documents including resolution steps on file with Aspire IRB?
Yes *No– Provide copies of all documents related to the issued determination including a description of the resolution steps
g. / Has the PI ever had an IRB terminate or suspend its approval of a study for any reason?
No Yes – provide explanation On File
h. / How long has the PI been conducting research? / First study < 1 year 1-5 years > 5 years
i. / On how many studies is the PI currently listed as the Principal Investigator?
j. / On how many studies is the PI currently listed as a Sub-Investigator?
k. / Has the PI attended any training specific to this study (e.g., Investigator Meeting, Site Initiation Visit)
Yes No – indicate the estimated date when the PI will complete this training:
SECTION 8: SUB-INVESTIGATORS / N/A
The following questions relate to Sub-investigators and research personnel. If there are no Sub-investigators assisting the Principal Investigator with this study check N/A aboveand proceed to SECTION 9. Changes or new information must be submitted to Aspire IRB in a timely manner.
a. / Have any co-investigators, any sub-investigators, or any research personnel that will be assigned to help conduct this research ever been issued any of the following:

At any time in the past:

Conviction of a crime
FDA Warning Letter
NIDPOE (Notice of Initiation of Disqualification Proceedings and Opportunity to Explain)
Suspension or termination by an IRB
Suspension by a federal or government agency (such as FDA, HHS, or Health Canada)
OHRP Determination letter, Health Canada Inspection Letter or similar

Within the past five years

Form FDA 483

No *Yes – specify the name of the individual(s)
*Are all related documents including resolution steps on file with Aspire IRB?
Yes *No– Provide copies of all documents related to the issued determination including a description of the resolution steps
b. / Have any co-investigators, any sub-investigators, or any research personnel that will be assigned to help conduct this research ever had any of the following denied, revoked, suspended, reduced, limited, placed on probation, not renewed, relinquished, sanctioned, fined, or subject to disciplinary action?

Clinical privileges at any site
DEA licensure
Fellowship/board certification
Medical licensure in any state, nation or province
Membership on any hospital staff
Prescribing privileges
Professional sanctions including fines and public reprimands
Professional society membership
Research privileges at any site

No *Yes – specify the name of the individual(s)
*Are all related documents including resolution steps on file with Aspire IRB?
Yes *No– Provide copies of all documents related to the issued determination including a description of the resolution steps
SECTION 9: STUDY STAFF
a. / How many key study staff members (e.g., PI, Sub-investigators, Coordinators, etc.)will assist in this study?
b. / Indicate the types of training that you and your research staff have had on the protection of human subjects. Select all that apply.
ACRP Certified Clinical Investigator Training
Collaborative IRB Training Initiative (CITI)
DIA Certified Investigator (CCI)
Local Institution's Training
Investigator Meeting
NIH Protecting Human Research Participants Course
OHRP Training Modules / SOCRA Clinical Research Professional (CRP)
Tri-Council Policy Statement online training (TCPS)
Training (Canadian Investigators)
WCG Sponsored Training
Other human subject protection training
None
c. / Principal Investigators are required to complete research-related training and/or education in the area of Good Clinical Practice:

Has the PI met this requirement? Yes No

Have all key study staff members met this requirement? Yes No

SECTION 10: COMMUNITY INFORMATION
a. / Are there any state or local laws governing the conduct of research in your community or state?
Yes – attach appropriate information / materials. No
b. / Are you aware of any community attributes (i.e., religious, ethical, ethnic, economic, political)that may affect the conduct of research at your study site(s)?
Yes – provide an explanation / No
SECTION 11: STUDY DEMOGRAPHICS
a. / Gender (must total 100%): / Male: % / Female: %
b. / Race (Check all that apply) / White
Black or African American
Hispanic or Latino
Asian
American Indian or Alaska Native
Native Hawaiian or Pacific Islander
Other (*please specify )
c. / Economic Status: / Upper Income / Middle Income / Lower Income / All Applicable
d. / Will any gender or group be excluded from the study?
Yes – attach a rationale for the exclusion / No / Per protocol
SECTION 12: SUBJECT ENROLLMENT INFORMATION
a. / What is the subject enrollment goal for the study?
b. / Please provide the anticipated dates for the following events:
First subject enrolled: / Last subject enrolled: / Last subject completed:
SECTION 13: SUBJECT RECRUITMENT
a. / Please indicate how you plan to recruit subjects for this study (check all that apply)
Patient Database (PI’s patients) / Referrals
Advertisements - Advertisements must be IRB-approved before their use
Telephone Screening Scripts – If this box is checked, please complete Aspire’s Phone Screen Information Form
Doctor to Subject Letters / Doctor to Doctor Letters (do not require IRB approval) / Other:
b. / Will you be using a centralized call service to screen callers?
Yes – submit telephone script and name of company / contact information. No
c. / Will audio or videotapes, photographs, DVDs, or other electronic records be made during any subject visits?
Yes – explain how you will maintain subject confidentiality / Provide Explanation:
No
SECTION 14: COMPENSATION FOR PARTICIPATION
a. / Will study subjects be compensated for their participation in the study?
Yes – complete this SECTION No – proceed to next section
b. / Subjects will be compensated for their participation in the research study as follows:
Total number of study visits:
Compensation for screening visit(s): / N/A
Compensation per completed study visit:
Additional compensation: / N/A
Compensation for telephone contact(s): / N/A
Total compensation:
Please attach a separate page if subject compensation is more complex than the breakout listed above.
c. / How will subjects receive their compensation? / Cash Check Other
d. / When will subjects receive their compensation*? / At each visit At study completion / Other
*Aspire IRB requires study subjects to be compensated at least quarterly.
e. / Will subjects receive any alternate form of compensation (i.e., gift certificates, free or reduced transportation, meals, parking, hotel accommodations, medications, etc.)?
Yes– provide an explanation and approximate value No
SECTION 15: VULNERABLE POPULATIONS

Do you anticipate recruiting subjects from the following vulnerable populations?

No (Skip to Question 3)
Yes – Check all applicable categories (see a-h) below.
Note: Marking the box beside a vulnerable population indicates your understanding of how to protect that group as outlined

Children: If this box is checked, you must complete questions 2 and 3 below

Assent will be solicited from subjects age 7 years and older
Investigator will ensure that outside parties (parent/guardian) are not unduly influencing subject to participate
Investigator will provide adequate opportunity for subjects to ask questions and comprehend information

Adults with Diminished Decision-making Capacity (Refer to Protocol to see if subjects requiring legally authorized representative [LARs] are allowed):If this box is checked, you must complete questions 2 and 3 below

Assent may be solicited from subjects with limited decision making capacity when appropriate
Investigator will ensure an LAR is used when appropriate or required by protocol
Investigator will ensure that outside parties (caregiver/LAR) are not unduly influencing subject to participate
Investigator will provide adequate opportunity for the subject to ask questions and comprehend information

Economically Disadvantaged/Unemployed

Compensation is reasonable in order to eliminate possibility of undue influence due to financial incentive

Educationally Disadvantaged

Investigator will provide adequate opportunity for the subject to ask questions and comprehend information

Visually Impaired or Illiterate – If this box is checked, an impartial witness signature line will be added to the informed consent form (if this is not already included)

Investigator will ensure the consent document is read to the subject and that an impartial witness is present.
Investigator will provide adequate opportunity for the subject to ask questions and comprehend information

Limited English skills and/or Non-US Citizens

Subject will be provided with translated documents in native language if unable to read English
Staff /independent interpreter has ability to interpret subject’s native language if unable to comprehend English
Investigator will provide adequate opportunity for the subject to ask questions and comprehend information
Do you need any documents translated? No Yes
List the documents that need translation
What language is needed?

Employees/Colleagues/Students of the Principal Investigator and/or Study Staff (must be acceptable by the sponsor/protocol). Aspire IRB will issue a non-coercion addendum or add non-coercion language to the Informed Consent Form for enrolled employees and family members.

Investigator will ensure & explain that participation does not affect subject’s current position
Approval documentation from sponsor is required

Pregnant Women

Possible risks to mother and fetus will be clearly outlined

If question #1 was answered NO, please skip this question.

When enrolling vulnerable population(s), will you meet the listed expectations to protect these populations?
No (Attach an explanation)
Yes
Describe any additional safeguards at the site to protect their rights and welfare.

Is an LAR or guardian acceptable as per the protocol?

No (Skip to Question 4)
Yes

If YES, will subjects with an LAR or a guardian be enrolled at this site?

No (Must answer Question 3b)
Yes (Skip to Question 3c)

If NO to Question 3a, and IF this study enrolls minors, will only biologic parents provide permission for enrollment?

No (Attach an explanation)
Yes

If YES to Question 3a, how will you verify who constitutes an LAR or a guardian in your state?

Legal counsel
Sponsor/CRO
State law reference material
State law codes and statutes
Other (specify):
SECTION 16: CONFLICT OF INTEREST
“Immediate family members” include spouses/domestic partners, dependent children and minors, and anyone who resides with the investigator or who is the investigator’s dependent for tax purposes.
“Financial interest related to the research” means financial interest in the sponsor, product or service being tested, or competitor of the sponsor.
Please note: all amounts referenced below apply to aggregate financial interests of immediate family members.
If you answer YES to any of the questions below, you must also submit the Conflict of Interest Management Form located at

a. / Does the PI, any Sub-investigator, member of the study staff and/or immediate family members entered into any financial arrangements whereby the amount or value may be affected by the outcome of the study?
No Yes
b. / Does the PI, any Sub-investigator, member of the study staff and/or their immediate family members have any equity interest related to the research exceeding $5,000 or 5% or greater interest in any single entity connected to the research? This includes, for example, any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices.
No Yes
c. / Does the PI, any Sub-investigator, member of the study staff and/or their immediate family members receive any payments exceeding $5,000 (excluding the costs of conducting the study) from the study sponsor? This includes, for example, grant funding, compensation in the form of equipment, retainers, consulting fees, or honoraria.
No Yes
d. / Does the PI, any Sub-investigator, member of the study staff and/or their immediate family members have any proprietary interest related to the research? This includes, for example, a patent, trademark, copyright or licensing agreement.
No Yes
e. / Does the PI, any Sub-investigator, member of the study staff and/or their immediate family members have a board or executive relationship related to the research, regardless of the compensation?
No Yes
f. / Does the PI, any Sub-investigator, member of the study staff and/or their immediate family members have any potential conflicts of interest that are not outlined above that may interfere with or influence the conduct or outcome of the study?
No Yes
If any of the above information changes during the course of the study and for one year following study completion, Aspire IRB will need to be promptly notified.
SECTION 17: CONFIDENTIALITY AND HIPAA INFORMATION
“Confidentiality” refers to an individual’s wishes as to how his/her identifiable private information will be handled, managed, and disseminated. Confidentiality is a means of protecting that information, usually by safeguarding it from unauthorized disclosure.
In this section, please note that all references to “Subjects” include potential, enrolled and past/previously enrolled subjects.
If any of your study sites are considered “covered entities” as defined by the HIPAA Regulations, please note that it is the Principal Investigator’s responsibility to ensure that all research activities conducted at the sites are HIPAA compliant.
a. / Please indicate the provisions to maintain subject confidentiality: (check all that apply)
Paper based records will be kept in a secured location and only accessible to personnel involved with the study.
Computer based files will be password protected and only be made available to personnel involved with the study.
Study personnel will be required to sign statements agreeing to protect the security and confidentiality of study information prior to being granted access to any study related information.
When feasible, identifiers will be removed from study related information.
Other – provide an explanation
b. / Will personnel not directly related to the research have access to study records or data (billing office, medical records, hospital personnel, etc.)?
No Yes – provide an explanation
c. / Will you be submitting HIPAA language for review?
No Yes – submit as a separate HIPAA authorization document or as a clearly identified HIPAA section in the Informed Consent Document.
Would you like Aspire to review your document for HIPAA? No Yes
d. / If any of your study sites are covered entities, will you require a partial waiver of authorization in order to screen for the study?
No Yes – complete a Request for Partial Waiver of Authorization Form.
SECTION 18: PRIVACY INFORMATION
“Privacy interests” refer to an individual’s interest in having control over the extent, timing, and circumstances of sharing oneself or information about oneself with others.
In this section, please note that all references to “Subjects” include potential, enrolled and past/previously enrolled subjects.
a. / Will personal information collected from subjects be limited to only that which is necessary for study purposes?
No / Yes
b. / Will subjects’ personal information be collected in a private setting/location?
No / Yes – Provide a description
c. / Will study-related assessments and procedures be conducted in a private setting/location?
No / Yes – Provide a description
d. / Are there any additional provisions at your site to protect the privacy of subjects?
No / Yes – Provide a description
SECTION 19: FEDERALLY FUNDED STUDIES
a. / Is this study federally funded? / No Yes – Name of Federal Agency(ies):
PLEASE PROVIDE A COPY OF YOUR GRANT APPLICATION FOR REVIEW
SECTION 20: MAIL DELIVERY INFORMATION
Note: All documents will be delivered via ASAP (Aspire’s Simple Automated Portal). If you would like hard copies sent to you, there will be an additional fee associated with this service.
a. / Will you require this additional hard copy service?
No –proceed to next section / Yes – complete remainder of this section
b. / Service Provider: / FedEx UPS Standard USPS
c. / Account Number: / Reference Number:
SECTION 21: BILLING INFORMATION
Contact Person:
Company:
Address:
City: / State: / Zip Code:
Phone: / FAX: / Email: / @
Payments should be sent with a copy of the invoice(s) to:
Aspire Independent Review Board, DEPT LA 24322, Pasadena, CA 91185-4322
► NOTE: Any changes to billing information must be sent to Aspire IRB at ◄
INVESTIGATOR AGREEMENT WITH ASPIRE IRB

As the Principal Investigator, I agree to uphold ethical standards and practices in research and conduct this research in accordance with applicable federal regulations, state and local laws, and requirements of Aspire IRB as follows: