What to Include in a Site SmartForm

The Site SmartForm is always associated with an additionally created Study SmartForm.  The Site SmartForm represents the information associated with a relying IRB.  The following section describes what information should go into each space of the Site SmartForm.

For sites where Harvard is relying on the review of another IRB (External IRB), see section: Requesting External IRB Review for additional instruction related to SmartForm page contents and submission requirements.

For sites where Harvard is the Reviewing IRB: Create the Site SmartForm and share it for review by competing the Add/Manage Participating Sites activity on the main study workspace.  During IRB review, this will create a site submission (with workspace) for your further edits.  This activity will only appear on the main study workspace when a study is marked on the Basic Information page of the Smartform as collaborative, where Harvard willl review for at least one site.

Add participating sites activity button

When a study is created and marked as multi-site or collaborative, where Harvard will review for at least one site, the Site SmartForm may be completed with the following information.  For existing projects, if a modification is required to indicate that a study is multi-site or collaborative, with Harvard reviewing for at least one site, the modification must be approved before a site can be added.

Site SmartForm Section: Basic Site Information 

1. Short title. The short title identifies the submission throughout the system, such as in your inbox and in an IRB reviewer's list of submissions to review.  This should be 80 characters or less, and should not contain quotation marks.  If left blank, the system will automatically pull in the first 80 characters of the response to question 1.

2. Local Principal Investigator. The options are limited to individuals with a Harvard ID/HarvardKey.  If the Local Principal Investigator name cannot be found on the list, enter the name of the Harvard Principal Investigator.  For details on who may be listed in this space, please visit your IRB website or Investigator Manual.  

This field will default to the name of the person completing the form.  It may be changed by selecting clear and typing the name in the space provided (a list will appear with names from which to select), or you can click the select option to search the list of names.  Use the “%” symbol to replace portions of a name which are unclear or possibly not spelled correctly.  This is called a “wildcard” character.

3. Does the investigator have a financial interest related to this research? Indicate if the Principal Investigator has a financial interest.  For more information regarding what constitutes a financial interest, please visit your IRB website. If an individual has a financial interest, complete and attach “FORM: Financial Interest Disclosure Form” to the to the Local Site Documents page of the SmartForm, via the document attachment prompt, when applicable. 

4. Brief description of activities this site will perform: Provide information about activities taking place at this site.

Site SmartForm Section: Additional Local Funding Sources  

On this page include any pending/awarded funding sources or financial support associated with the site, which Harvard must review and not included with the main study SmartForm review. .

Identify any additional organization supplying funding for the local site. List all other funding sources.  Attach a complete copy of the funding application or agreement for these listed sources to the Local Site Documents page of the SmartForm, via the document attachment prompt, when applicable, and remove or black-out any salary information.

Site SmartForm Section: Local Site Documents

This page of the SmartForm is intended to capture documents that will be used by the site researchers, but is under Harvard review. Ensure that the document versions attached here are relevant to for the specific site under review.  Use the main study submission for Harvard documents and use this page of the Site SmartForm to attach only versions of documents specific to this site, only when appropriate. 

Attach other supporting files, naming each file as it should appear in the approval letter: Also, be sure to name the file itself in a manner that identifies it as associated with your study. The suggested best practice for file names: StudyNumber_DocumentName_VersionNumber

When uploading documents to this page, you are prompted to select the appropriate attachment category.  Select the correct category when uploading the first version.  Once chosen and saved, the attachment category cannot be changed.  To change a category, a document must be removed and then re-uploaded with the new category.  

Use the “other” category to attach non-document type attachments which must be part of the review (such as compressed/zip, video, audio, or htm file formats).  

Items to attach to this page:

  • Consent, Assent Forms, or Scripts including HIPAA Authorization Forms
  • Recruitment Materials
  • Study Instruments/Tools   
  • Funding Source Attachments. If not associated with GMAS and as applicable, submit a complete copy of the grant applications, subcontract, and/or any funding agreements regardless of funding source. 
  • Data use agreements or other Agreements.  Submit copies of any documents authorizing the use of data, or other contracts or agreements associated with the study.
  • IRB/SmartIRB Cede Request or IRB Authorization Agreement (IAA). When multiple institutions are engaged in the Human Research, submit this form allowing an investigator to designate Harvard as the Reviewing Institution (responsible for IRB review).  To request such an agreement with a SmartIRB participating institution, visit this link.

Upon clicking continue from this page, the browser will direct to the last page of the SmartForm where you will have the opportunity to select “Save & Exit” to return to the submission workspace.