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Protocol

 

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Figure 142 Protocol Page
Figure 142 Protocol Page

The Protocol page is by default the first page displayed upon creating a new protocol document or accessing an existing one. An entire protocol document is comprised of seven pages: Protocol, Personnel, Questionnaire, Permissions, Notes & Attachments, Protocol Actions, and Medusa. By default, the Protocol page is the first page displayed when either creating a protocol or accessing a saved one. There are three tabbed sections located within the Protocol page: Document Overview, Required Fields for Saving Document, and Additional Information. These sections collect general information fundamental to the protocol such as title, Principal Investigator (PI), funding source, and protocol participants.

Section Name & Topic Link Description
Document Overview General information.
Required Fields for Saving Document Minimum identifying information.
Additional Information Attach additional reference numbers such as FDA IND or IDE numbers.

Table 52 Protocol Document, Protocol Page – Section Descriptions

 

Required Fields for Saving Protocol

Figure 143 Protocol Document, Protocol Page – Required Fields for Saving Document
Figure 143 Protocol Document, Protocol Page – Required Fields for Saving Document

There are five fields on the Protocol page that are required to be completed before the protocol can be saved and being able to move on to another page.

Field Section Description
Description Document
Overview		 The text entered into this field should be a short title to describe the project. The limit for this field is 40 characters.
Protocol Type Required Fields for Saving Document Select the appropriate review type for the protocol from the eight (8) options in the drop-down drop down menu: CIRB, Clinical Trials (External Protocol Only), Emergency Use, Exempt, Expedited, Full Board, Humanitarian Device Use (HUD), Non-Human Subject Research (NHSR). The selected type will imply the level of review the protocol will likely require; however, the final determination of review will be made by the ORIC.
  • This selection will determine the questions that will be required on the Questionnaire page. If you need assistance determining the type of protocol you are submitting, please review the Human Subject Regulations Decision Charts.
Title Required Fields for Saving Document Enter the full title for the protocol by clicking within the text box and entering the required text or clicking the add note note icon icon to view/edit/paste text in a new browser window. Click the continue button to return to the text entry field in the document. The limit for this field is 2,000 characters.
Principal Investigator Required Fields for Saving Document Indicate the person who will have absolute responsibility for the overall conduct of the research by clicking the search search icon icon to search personnel registered in the WVU Identity and Access Management system. Return the value to add the designated person to the protocol. This selection will become read-only after saving; however, a Co-I can be changed to a PI on the Personnel page by clicking on the detailed information section of that particular person.
Lead Unit
(Department)		 Required Fields for Saving Document Indicate the department that is the primary home of the PI. Click the search search icon icon to search available WVU units or enter the department number manually in the text box provided. This selection becomes read-only after saving. Additional units may be specified on in the Unit Details of the PI located on the Personnel page.

Table 53 Protocol Document, Protocol Page – Required Fields for Saving Document Descriptions

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