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 196 Proposal Development Document > Special Review Page > Special Review Section – Example

 

Figure 197 Proposal Development Document > Special Review Page > unlinked module type 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

Once a selection is made, additional fields are required.  The type indicates which special review, if any, is relevant to the document.  Type selections include use of human participants, animal usage, biohazard materials, foundation relations, international relations, etc. 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 if a type is selected.  Select from the list to indicate if the special review relevant to the document is pending approval, or already approved.

Protocol Number

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.

Depending on implementation, you may type the value if known in the box, or you may be required to search for and select it and populate the box automatically by using either the lookupsearchicon or direct inquiry functions.

Application Date

Enter 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

Enter 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

Enter 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 #

Select 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

Add is presented in the initial header line. After line items have been added, the delete button appears in this column to allow the line to be removed by clicking the delete button.

 

Special Review linking Enabled to Protocol Documents

 

The Special Review page is integrated with the Human Participants (IRB) and Animal Care (IACUC) modules to allow the linking of Proposal Development, Institutional Proposals, and Award documents to IRB Protocol and IACUC Protocol documents.

When the system has been implemented to enable the protocol linkages, users will need to do one of the following to complete the required fields:

1.  Use the lookup to locate and select an existing protocol record that conforms to the sponsor requirements (appropriate status and valid dates)

2.  Start a new protocol record to support the proposal submission.

Figure 198 Proposal Development Document > Special Review Page > IRB Module Link Enabled– Example. The user must search the IRB Protocol module for a record; the date fields and the exemption numbers are not presented to maintain. If a record does not exist, the user may begin a new protocol record by selecting the “start protocol” button.

 

Option 1:Link to an Existing Protocol document:

 

1.

In the Type field, select ‘Human Subjects’ or ‘Animal Usage’ 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 searchicon.

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.

 

Option 2: Start a New Protocol document:

 

1.

In the Type field, select ‘Human Subjects’ or ‘Animal Usage’ 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 searchicon and a start protocol button appears below the ‘add’ and ‘renew’ buttons in the last column on the right.

2.

Click the ‘start protocol’ button

 Oops! Sorry folks, we have a bug in this release. We will correct this in a future release.

 

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.