Submission Navigation

Once you open a submission, you see the webpage for this submission; also referred to as a “workspace”. The workspace is your access point for:

  • Viewing the submission contents and details, including all actions performed on it
  • Performing actions on the submission

The figure below identifies the key workspace elements that help you find your way around the IRB system and perform actions on the submission.

Workspace Regions
Image displays the Initial/Main study workspace for reference.
Layout of the submission workspace

Region

Information in this region

1

Breadcrumb Available in all workspaces, click the double arrow [>>] to view the breadcrumb bar.  This provides additional navigation links to the parent page for each view.  Use links to navigate to the following information:

  • IRB for all submissions,
  • Study name to navigate to the Initial/Main study workspace, or
  • Submission name to navigate to the submission workspace.

2

Status Visible in all workspaces, the status region will show:

  • The status of the submission once it is created and through the review process,
  • Information about when a submission was sent to the IRB and updated, and 
  • Initial/Main study workspaces also display the initial and approval end (expiration) dates for reference, as applicable. 

3

Next Steps Visible in all workspaces, this set of blue buttons allows for:

  • Editing or viewing the current submission  SmartForm,
  • Displaying a printer version,
  • Viewing changes over time, and
  • On Initial/Main study workspaces only: Creating new Continuing Review, Modification, or Reportable New Information submissions for the study.

4

Activities Visible on all workspaces, activity buttons display depending on the type of submission, the status of the submission, and your role on the study.  Mostly, activities displayed take action on the submission only.  However, Assign PI Proxy, Assign Primary Contact, and Manage Guest List are only visible on the Initial/Main study workspace.

5

Submission Overview This section displays the following submission-specific items for reference:

  • Number and name of the submission/workspace being viewed,
  • PI, submission type, primary contact, and IRB office and coordinator (if one is assigned),
  • IRB determination letter (labeled “Letter”), if a determination has been made
  • Regulatory Oversight to indicate if a submission is/was subject to review under pre-2018 Common Rule or 2018 Common Rule
  • Image of the state of review for the submission.  Note that when viewing an Initial/Main study workspace the image may indicate “review complete” while an associated submission (such as a Continuing Review or Modification” is under review)

6

Submission Tabs On a submission, the Initial/Main study workspace shows all current approved details (including documents and study team members) while all follow on submission workspaces display information that was proposed at the time of review and determination.  Click on tabs to view:

  • History Information about each action taken on a submission and in-brief view of comments.
  • Funding List of all funding listed on the SmartForm, with a link to GMAS, if applicable.
  • Project Contacts List of study team members listed on the SmartForm, including current Human Subjects Training information on file.
  • Documents Draft and finalized documents submitted for review, with versioning information for each document.
  • Site Links to associated Site workspaces for a study (only visible on the main study workspace of collaborative projects where Harvard is the IRB of record for at least one site)
  • Follow-on Submissions Links to Continuing Review, Modification/update, Sites, or Reportable New Information workspaces for a study (only visible on the main study workspace) with quick access to all determination letters
  • Reviews View additional details about the review, including ancillary review details, data security level determinations, and completed checklists.
  • Snapshots View of the application at each change in state (for example, the appearance of the SmartForm between pre-review and changes submitted).

Once a determination is made on an initial submission, two things change about the initial submission workspace, also referred to as the “main study workspace”:

  • The main study workspace is the webpage where all current information about the study is located, including the most current approved study documents and the current expiration date, as applicable.  
  • Additional submissions that follow initial determination may be created from the main study workspace.  These modifications/updates, continuing reviews, sites or reportable new information are referred to in the system as “follow-on submissions”.  Follow-on submissions which are associated with a study can also be accessed from the initial submission/main study workspace.