Access to Studies by Role

Access to a study is personalized based on role in the system and the role one plays in relation to the particular study. The following table summarizes the policies controlling the visibility of submissions (both studies and follow-on submissions):

User Role Information Visibility
Study staff

Access to submissions that include you on the study team, as the primary contact, or on the guest list. You cannot view the assigned reviewers or committee members, or gain access to the reviewers' comments. You can view the date and time of any meeting to which the submission is assigned.

Current members of the study team manage this access by completing the Assign Primary Contact or Manage Guest list activities or by adding/removing names from the Study Team Members page of the SmartForm.

IRB staff, IRB committee members

Access to all submissions. For studies that include you on the study team, you cannot gain access to the IRB reviewers' comments, private comments or certain review activities.

IRB staff and the site manager manage this access.  Following official request sent to the estrhelp@harvard.edu, the site manager adds a system role to the individual person profile, then IRB staff complete activities on the Committee workspace to change Committee membership.

Ancillary reviewers, other reviewers who are not IRB committee members

Full access to submissions assigned to you for review, except site workspaces.  Site additions can be viewed on the main study workspace.

IRB staff and the site manager manage this access. Either IRB staff identify the reviewer by name when assigning ancillary review; granting access OR following official request sent to the estrhelp@harvard.edu, the site manager adds reviewers to the appropriate department.

Administrative office viewers, those with read-only access to all submissions reviewed by the IRB or which are associated with a particular department

Read only access to all submissions associated with the IRB or department.

IRB staff and the site manager manage this access. Following official request sent to the estrhelp@harvard.edu, the site manager adds viewers to the appropriate department within the organization profile or Administrative office via settings.

Site Manager

Full access to all submissions.

Current site manager manages this access on the person profile.

 

IRB Review Activity Visibility Summary
The following table summarizes the visibility of review activity details on the submission workspace history or review tabs.

Table of activity visibility