NEEDS TO BE AMENDED TO SPONSOR INFORMATION
PI Application Related Information:
The term "multi-site" refers to studies with multiple Principal Investigators, where each is responsible for the conduct of research at their own site(s). Often in multi-site studies, the sponsor of the project may elect to utilize E&I as the "central" IRB to review the study and all (or part) of the included investigators. In such cases, the included investigators will submit for review under this section.
[G] indicates a link to more information about a requirement. Additional guidance can be obtained under the Education section of the website.
When a sponsor selects E&I to serve as the central IRB, the sponsor (or CRO) will submit the protocol, consent form, and other relevant study-wide information to the board for review and approval on behalf of the investigators.
Prior to beginning conduct of the research, each investigator must also obtain the approval of the IRB. This is a regulatory obligation of the board to consider the local perspective of where the study will take place. As part of this consideration the board will determine whether or not the investigator's training and experience qualifies them to perform the designated functions required by the design of the study. Before approving an investigator, the board must first obtain relevant information about the individual. This information is typically requested in a PI application form (also referred to as a submission or cover form.)
There are many different types of projects that an investigator may wish to take part in. The type of information the board will need is directly related to the type of study the investigator will be conducting. E&I specializes their PI application forms into two types, clinical and non-clinical research.
In addition to submitting an E&I PI Application form, each PI must also provide other required items, and may be asked to provide additional supplemental information as well.
To make your submission process easier, an application checklist identifying these items is built into each of the PI Submission forms.
Items required with every submission:
- PI Application Form, signed (30A or 30B) [G]
- Current, dated CV
- Copy of current professional license
- SOP of Consenting Process [G]
- Facility description or brochure
- Human Subject Training certification(s) [G]
Based on the information provided in your E&I PI Application Form, additional submission items, or supplemental forms may be required.
Items required only if applicable to your site:
- Advertising and recruitment materials specific to your site, not already submitted by sponsor for study-wide use [G]
- E&I Special Populations Form 25A-D
- E&I Conflict of Interest Form 31
- E&I Additional Sites Form 32
- E&I Local IRB Waiver Form 33 or 34
- Letters of explanation as indicated on application form
- Documentation of FDA audits
Complete List of PI Application Related Forms:
Principal InvestigatorI Application (either 30A or 30B):
E&I PI Application Clinical Investigation Bio-medical (Form 30A)
Clinical (Drug and/or Device) Research Submissions for review of these types of studies typically include a clinical investigation of a product or device and usually fall under the regulatory requirements of the FDA. These studies are often designed to test safety or efficacy of a product.
E&I PI Application Non-Clinical / SBER (Form 30B)
Non-Clinical (Social, Behavioral, Educational) Research These types of projects typically do not test safety or efficacy of a product, but may at times involve products or devices in their design. Often non-clinical research will fall under the regulatory guidance of OHRP (link to 45 part 46), which varies slightly from FDA regulatory language.
Supplemental Forms (as indicated):
When indicated on the PI Application form, these forms should be completed and attached to the submission packet.
E&I Conflict of Interest Form 31
To identify potential conflict of interest as well as possible plans to manage it.
E&I Local IRB Waiver Form 33 or 34
To assure that your local IRB agrees to waive jurisdiction to E&I.
E&I Satellite (Additional) Sites Form 32
To identify any additional satellite sites where the PI plans to conduct study procedures.
E&I Supplement Employees Form 25A
When the PI intends to include employees as study participants.
E&I Supplement Pregnant Women Form 25B
When the PI intends to include pregnant women as study participants.
E&I Supplement Prisoners Form 25C
When the PI intends to include prisoners as study participants.
E&I Supplement Children Form 25D
When the PI intends to include children as study participants.