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Medical Device » Submitting a Study:
Studies for review may be submitted via email, FedEx, UPS, DHL or the United States Postal Service.
Mail:Asentral, Inc. IRB
10 Mulliken Way
Newburyport, MA 01950
The submission deadline for consideration on the following week’s IRB meeting agenda is Thursday at noon. All information and forms must be at Asentral before Thursday at noon in order to be placed on the next week’s agenda. Asentral staff will work with sites, Sponsors, and CROs to conduct a quick review for completeness and accuracy of your submission.
Please note that all required information and forms must be accurate and complete before a slot on the IRB agenda can be reserved.
Below is a list of information and forms to be included in your IRB submission packet from the Principal Investigator and Sponsor/CRO. A review cannot be performed until all appropriate information has been received.
Initial Study Submission Forms
- Guidelines for Submission Packet
- Indemnification Agreement
- Exempt Status Application
- Sponsor Application Form
- Sponsor Waiver of Informed Consent Form
- Study Application Form
Identifies standard procedures for review services. Please note that if this is a multi‐site study, the Sponsor needs to complete the "Sponsor Application Form." The sites will complete the "Study Application Form."
Between Sponsor and IRB (note that if the study is an Investigator‐initiated study, the Investigator needs to indemnify the IRB).
Provides the service agreement between Sponsor, site and IRB.
Waiver or alteration of informed consent or written documentation of informed consent
Needs to be submitted along with:
- Investigator's Financial Disclosure statements.
- Documentation of any FDA audits within the past three years.
- Letters of explanation (if needed) or additional information to support the study application questions.
- Investigational Drug Brochure or Package Insert(s), if applicable.
- For medical device studies:
- Copy of the operator's manual.
- Letter from the FDA granting the Investigational Device Exemption (IDE)
Letter of non-significant risk from Sponsor
Letter of explanation as to why the investigation is exempt from the IDE requirements under 21CFR812.2(c) or otherwise exempt.
- Study Protocol with signed Protocol Signature Page.
- Informed Consent Form(s) with hard copy and electronic file of Microsoft Word compatible.
- Assent Form - must be used when minors are participating as subjects in the study, with hard copy and electronic file of Microsoft Word compatible.
- Proposed Subject Information (if any).
- Copy of the signed Form FDA 1572 (if applicable).
- Proposed Advertising/Recruitment material (if any) and participant study materials. The rule of thumb is that anything that the study subjects are asked to read, listen to, watch, or respond to needs to be submitted for IRB review.
- Curriculum vitae (CV) of the Principal Investigator and all Sub-Investigators. CVs must be current within 1 year, include any medical license information and be signed and dated. Massachusetts sites please include the Massachusetts Research Registration Number from the Department of Public Health for the PI.
Additional Information for Vulnerable Populations - If you plan on enrolling a vulnerable population in your study, pick the appropriate form below.
- Children -
- Cognitively Impaired Populations -
- Pregnant Women, Fetuses & Neonates -
- Economically Disadvantaged Population -
- Research Involving Students Employees and Relatives -
- Research Involving the Terminally Ill -
- Satellite Site Application Form
- Shipping & Invoicing Information Form
- Financial Disclosure Form for Investigators
- Researchers Experience Worksheet
For each site listed in section #3 of the Form FDA 1572 (if applicable) or listed as a Satellite Site on the Study Application Form.
Specifies delivery and billing information