Key Changes Version 1.0 2/1/2017

New and Key Changes to Terminology with ETHOS The transition to ETHOS is an exciting time for the IRB and research teams alike. Some of the new terms and key differences of terminology changes that you can expect are listed below. ETHOS Create a New Study Clarifications Requested Modifications Required Modification Continuing Review (CR)

Old Completing an Application Pre-Review Changes Requested Stipulations Change in Protocol Continuing Renewal

Reportable New Information (RNI)

Report Forms

Comment

Emails

Editable State

Revising

Follow-On Submission

History

Change in Protocol, Report Form, Change in Personnel N/A

Primary Contact

N/A

Understanding the Change ETHOS now incorporates all parts of a research plan in to one study. ETHOS provides a study workspace for the study protocol, study documents, and all other information related to the study. This state indicates that IRB staff has identified elements of the study to be revised before Pre-Review can be completed. A submission will remain in this state until the Submit Changes activity is completed. This state indicates that the IRB has identified elements of the study to be revised before a determination can be made. A submission will remain in this stat until the Submit Response activity is completed. Changes to your study are now called Modifications. This applies to changes after approval by the IRB. Regulations require the IRB to review of each active study at least annually. This new term reflects that IRB review must be conducted by to secure continuing approval. You can initiate continuing review by clicking the Modifications/CR button in ETHOS RNI constitutes any new information that the IRB must be made aware of by an investigator. The new form helps distinguish what can be reported at Continuing Review and what should be reported immediately. Comments replace use of email communication related to your submission. Comments are tracked within the submission history for accurate recording. State in the workflow where review has stopped and the submission may be edited by the Principal Investigator or Study Staff. After edits are completed, the submission must be submitted (or response submitted) to move to the next state of review by the IRB. This refers to all submissions associated with a study after the initial determination is made, including Continuing Reviews, Modifications, and RNI.

This tab in a submission workspace displays all activities which have occurred on the submission, including messages between the IRB and Study Staff. A person identified by the Principal investigator or study staff who serves at the main contact for a submission, typically the study

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Key Changes Version 1.0 2/1/2017

Snapshot

N/A

Wildcard

N/A

Workspace

Email Process

coordinator. This defaults to the person who completed the initial submission but can be changed at any time. This is also the only person, in addition to the PI, who will receive email notifications generated by ETHOS. A visual display of a submission (including uploaded documents) at a point in time to allow for historical reference of study changes. Use of % [percent symbol] aides in search fields by allowing search of known elements at the beginning, middle, or end of a field. An ETHOS webpage which displays all information and available activities for a submission or study. For example, an RNI workspace, a Modification workspace, a study workspace, etc.

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