Protocol Exception

The Protocol Exception section helps document any deviation or departure from standard procedures as stated by the Guide for Care and Use of Laboratory Animals. For e.g. The Guide might state that if dogs are to be used as Laboratory animals they need to be exercised certain number of times in a day. If the proposed research involving dogs cannot adhere to this standard, the investigator needs to provide justification within the Protocol Exception section.

Figure 858 Protocol Document – Protocol Exception – Columns Exception through Species

Figure 859 Protocol Document – Protocol Exception – Columns Exception Justification and Description through Actions

Table 448 Protocol Document, Protocol Exception

Field	Description
Exception	Required. Select exception to standard procedures from the list of values. The values displayed to the investigator are • Food/Water Restriction, • Exemption from Dog exercise program, • Multiple Major Survival Surgery, • Exemption from the environment enhancement plan for non-human primates • Maintaining temperatures outside of the recommended ranges • Exemptions to routine cleaning/husbandry requirements • Exemptions to the diurnal lighting cycle requirements • Exemptions to the space requirements including innovative caging and metabolism cages • Prolonged restraint • Use of non-pharmaceutical drugs • Death as an end-point • Monoclonal antibodies production via acities • Use of wire bottom cages for rodents • Singly housing social species 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.
Species	Required. Select the species for which the investigator is deviating from standard procedure. 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. Only the species selected within the Species/Groups page will be available for selection within the Species list within the Protocol Exceptions page.
Exception Justification and Description	Describe the reason or justification for departing from standard procedures. To enter textual information, click within the text box (or press the tab key from a previous field) to relocate the cursor to 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 add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document.
Exception Count	Enter the count of the number of species to which the procedure exception will apply. To enter the number, click within the box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter the number in the box as necessary to provide the appropriate information
Actions	Required. Click the add button after you’ve made your selections to cause the procedure exception to be added as a numbered row in the table below. Click the delete button to remove a previously-added line item row from the table. For more information about basic line item functionality, see “Common Line Item Operations” in Common E-Doc Operations.