Joining a Multi-site Study

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. Note: This is not the same as one investigator who has multiple performance sites.

[G] indicates a link to more information about a requirement. Additional guidance can be obtained under the Guidance menu on the website.

When a sponsor requests 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 approval by the IRB. The board has a regulatory obligation to consider the “local” perspective 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 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 supporting documentation to show experience and training. 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 30a, signed
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 25 (a-d)
E&I Additional Performance Sites Form 33
Waiver from Local IRB
Letters of explanation as indicated on application form
Documentation of FDA audits

Forms:

Standard Forms:

E&I PI Application Clinical / Biomedical (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) Available on request

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 Available on request

To assure that your local IRB agrees to waive jurisdiction to E&I.