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.

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 lookup 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.