Compliance – IRB

The Compliance group on the Maintenance menu houses links to maintenance documents that are used to create and maintain database table records that are used by the IRB functional module in the KC system.  The data values in these maintenance documents are made available for use in e-docs such as the IRB Protocol document and the IRB Committee document.  Within a standard e-doc, lookup and dropdown list fields exist in sections that allow for the searching for and selecting of data value options that are maintained using these maintenance documents to populate them when preparing and completing the e-doc.

 

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Lookup/Create New Concept:  Typically, maintenance document links (bullet list of underlined text within labeled group boxes on the Maintenance menu) take you by default to Lookup screens that contain a create new  button at the top, right of the screen.  The lookup screen is used to optionally enter and/or select search criteria and then click a search  button to retrieve existing records in a search result table below the search criteria area of the screen.  The search result table contains an Action column at left that then allows you to take actions such as edit to access the existing maintenance document.  To create a new maintenance document, clicking the create new button allows you to initiate and display a new, blank maintenance document.

 

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Figure 1888 Compliance – IRB  Group on the Maintenance Menu

 

 

 

 

 

Subtopics:

Batch Correspondence

Correspondence Generated

Correspondence Template

Correspondence Type

Correspondent Type

Exempt Studies Checklist

Expedited Review Checklist

Organization Correspondents

Participant Type

Protocol Action Notification Template

Protocol Action Type

Protocol Affiliation Type

Protocol Attachment Group

Protocol Attachment Status

Protocol Attachment Type

Protocol Attachment Type Group

Protocol Contingency

Protocol Follow-up Actions

Protocol Person Role

Protocol Online Review Determination Recommendation Codes

Protocol Online Review Status Codes

Protocol Organization Type

Protocol Review Type

Protocol Reviewer Type

Protocol Status

Protocol Type

Reference Type

Risk Level

Submission Status

Submission Type

Submission Type Qualifier

Unit Correspondents

Valid Protocol Submission Review Type

Valid Protocol Submission Type Qualifier