Open Studies

To Complete an Action on an Open Study

Submit the corresponding form in CLARA. The titles of most forms are self-explanatory. Some new forms/uses of forms are:

  • Modification: Use to respond to an audit from the UAMS Office of Research Compliance or ACH/ACHRI Corporate Compliance (in addition to the usual use of making a change to an open study).
  • Staff Only Modification: Use for staff changes ONLY. Staff changes are those that add and/or remove staff, or change staff roles, responsibilities, or notifications.
  • Reportable New Information: Use to report study events to the IRB. Study events include adverse events, deviations, and notifications. See Reporting to the IRB for more information on how to use this form.

Only one form can be in process on a study at any given time (excluding Reportable New Information forms). 

To Be Placed on a Meeting Agenda (for Full Board Review)

Submit the required materials in CLARA by 4:30 p.m. Monday, two weeks prior to the meeting date, as outlined here.