Special Review

 

The Special Review page has a single tabbed section also labeled Special Review that provides the standard add line item functionality described in the Common E-Doc Operations section of KC Overview.

Figure 183 Proposal Development Document > Special Review Page > Special Review Section – Example

 

Table 77 Proposal Development Document > Special Review Page > Special Review Section – Field Descriptions

Field

Description

Add

The line where you make your entries and selections and click the add button, which adds them as numbered line items below.

Type

Required.  The type indicates which special review, if any, is relevant to the document (proposal/award/irb).  Type selections include use of animal usage, biohazard materials, foundation relations, human participants, international relations, radioactive isotopes, recombinant DNA, space changes, TLO PR-Previously Reviewed, TLO Review – no conflict (A), TLO Review – potential conflict (B2), TLO Reviewed – no conflict (B1).Click the down arrow  to display the list and click on an item in the list to highlight and select it to populate the box with your selection.

Approval Status

Required.  Select from the list to indicate if the special review relevant to the document (proposal/award/irb) is pending approval, or already approved.

IU Protocol ID

The unique identifier assigned to the protocol submitted for regulatory review. The protocol # is the number assigned to the protocol submitted by the PI to the institution's relevant committee (e.g. IACUC, IRB, etc.).  A unique number assigned by the institution and/or compliance committee to a specific research Protocol. Type the value if known in the box, otherwise, search for and select it and populate the box automatically by using either the lookupsearchicon or direct inquiry functions.

Application Date

The date the  protocol was submitted to the regulatory committee. The application date is the date the PI submitted a protocol/request for permission to the relevant institutional committee/person for special Review.  Enter the date in mm/dd/yyyy format or select it using the date selector by clicking on the calendar icon .

Approval Date

The date the  protocol was approved by the regulatory committee. The approval date is the date the protocol/request for permission was approved by the relevant institutional committee/person.  Enter the date in mm/dd/yyyy format or select it using the date selector by clicking on the calendar icon .

Expiration Date

The date, after which, the existing protocol expires. Enter the date in mm/dd/yyyy format or select it from the calendar selector to specify the date this special review will expire.  Enter the date in mm/dd/yyyy format or select it using the date selector by clicking on the calendar icon .

Exemption #

One of six categories of exempt research specified by the Common Rule (45 CFR 46.101(b).   If the proposed project is exempt, as defined by the different institutional committees, an exemption number is generally issued, and is entered into this field.  Scroll the spin box to view the list items from which to select.

Comments

Type to enter internal notes relevant to the protocol or special review item.

Actions

After line items have been added, they may be removed by clicking the delete button.

 

Linking To A Protocol Document

The Special Review pag e is integrated with the Institutional Review Board module to allow the linking of Proposal Development and Institutional Proposal documents to Protocol and Committee documents.   This also works if Institutional Proposal is then linked to an Award document.  The ‘irb.protocol’ parameter enables the linking of Protocol to Proposal and Award.

To link to a Protocol document:

1.

In the Type field, select ‘Human Subjects’ from the list.  Use the drop-down  menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

The Protocol Number column field becomes editable with a lookup icon.

2.

Enter the document number for the Protocol document you want to link to, or click the lookupsearchicon icon to search for and return the value to populate the box automatically, or if known, type the value in the box.

The Approval Status, Application Date, Approval Date, Expiration Date and Exemption # fields are automatically populated based on your selection when the data exists.

3.

Enter comments as desired.  Click within the text box (or press the tab key from a previous field) to reposition the cursor so that it is within the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information.  Click the expand text  icon to display a pop-up window with an expanded text entry area if you want more screen real estate to type in, and then click the continue button to close the window and return.  After text has been entered and saved, click the green arrow icon to read it in its entirety in the larger pop-up window, and then click the close button to close the window and return.

4.

Click the add  button in the Actions column.

Your selection/entry is added as a numbered line item row below the Add row.

Viewing The Linked Document

5.

Click the view  button in the Actions column for the numbered line item row of the document you want to view.

The Protocol document appears in a new browser window.

 End of activity.