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Single-site Studies
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Information:

When the sponsor of a multi-site study does not identify a "central" IRB for the included investigators to utilize, the investigators may elect to submit to E&I for review and approval of their "single-site" milfs
participation in the project.  This section will assist investigators wishing to submit to E&I for approval of study conduct as a single-site. 

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

Although the investigator is not the sponsor in this type of submission, in a single-site study the IRB's relationship is solely with the investigator.  In single-site studies, the investigator (prior to beginning any study related activities) is responsible for obtaining IRB approval of the study in addition to gaining approval for their participation as the Principal Investigator.

In some cases, review by the full board may not be required for study conduct approval.  When the proposed protocol is determined to be less than minimal risk, and qualifies under one of seven specific regulatory criteria categories, the study may be determined eligible for review by an expedited review [G] process.  If you believe your study may qualify under the applicable regulatory requirements for expedited review, and would like your project reviewed utilizing this process, you will be asked to submit an E&I Request for Expedited Process (Form 22) as part of the Study Application Form.  E&I is always willing to discuss the specifics of any given study to assist an Investigator in determining what their review needs are in accordance with the regulations.

There are many different types of projects that an investigator may wish to take part in.  The type of information the board will need to perform their review is directly related to the type of study the investigator will be conducting.  E&I specializes their application forms into two types, clinical and non-clinical research.

Items required with study submission:                                        

  • Study Application Form, signed (21a or 21b)
  • Copy of Protocol detailing the research aspects [G]                             
  • Consent Process, or Waiver of Informed Consent Process [G]
  • Consent document(s) or Waiver of Informed Consent Form [G]         
  • Form 1572 (if applicable)
  • Investigator Brochure or package insert (Drug studies)
  • Device Brochure (Studies involving a device)
  • Recruitment Materials, Ads, Screening Scripts [G]                             
  • Surveys, Interview outlines
  • Case Report Forms (review only, not approved by the board)
  • Anything else considered to be part of the protocol

The IRB has a regulatory obligation 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 and their location.  This information is typically requested in a PI application form (also referred to as a submission or cover form.)

Item required with PI submission:                                                 

  • PI Application Form (30a or 30b)                                                    
  • Current, dated CV
  • Copy of current professional license
  • Facility description or brochure
  • Human Subject Training certification(s) [G]

Based on the information provided in your E&I Application Forms, additional submission items, or supplemental forms may be required.

Items required only if applicable to your site/study:      

  • E&I Request for Expedited Review Form 22
  • E&I Investigative Drug Form 24a (Available upon request)
  • E&I Investigative Device Form 24b [G]                                               
  • E&I Special Populations Form 25a-d
  • E&I Waiver of Informed Consent Process 26a
  • E&I Waiver of Informed Consent Form 26b
  • E&I Waiver of HIPAA 26c
  • E&I Waiver of FERPA 26d
  • E&I Conflict of Interest Form 31
  • E&I Satellite (Additional) Performance Sites Form 33
  • Waiver of Jurisdiction from Local IRB
  • Letters of explanation as indicated on application form
  • Documentation of FDA audits

 

Forms:

Standard Forms:

For 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 Study Application Clinical Investigation / Bio-medical (Form 21a)

E&I Principal Investigator Application Clinical / Bio-medical (Form 30a)


 

For 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.

E&I Study Application Non-Clinical Investigation / SBER (Form 21b)

E&I Principal Investigator Application Non-Clinical / SBER (Form 30b) Available on request

Supplemental Forms (as indicated):

 

When indicated on the PI Application form, these forms should be completed and attached to the submission packet

 

E&I Request for Expedited Review (Form 22)

To identify your request for the expedited review process and the category being claimed.

E&I Investigative Drug (Form 24a) Available on reqeust

To provide additional information needed only for investigative drug studies.

E&I Investigative Device (Form 24b)

To provide additional information needed only for investigative device studies.

E&I Supplement Employees (Form 25a)

When the PI intends to include employees, family or friends 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.

E&I Waiver of Informed Consent Process (Form 26a)

When the PI intends to waive some or all of the informed consent process for any or all participants.

E&I Waiver of Informed Consent Documentation (Form 26b)

When the PI intends to waive documentation of the informed consent process for any or all participants.

E&I Waiver of HIPAA (Form 26c)

When the PI is covered entity and intends to fully or partially waive HIPAA for any or all participants.

E&I Waiver of FERPA (Form 26d)

When the PI is covered entity and intends to fully or partially waive FERPA for any or all participants.

E&I Conflict of Interest (Form 31)

To identify any potential conflict of interest as well as plans to manage it.

E&I Local IRB Waiver Available upon request

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

E&I Satellite (Additional) Performance Sites (Form 33)

To identify any additional or satellite sites, which the PI intends to conduct study procedures.

Last Updated ( Wednesday, 16 September 2015 14:26 )