Alternate Search

 

The investigator is required to enter information about alternate database or literature searches they have performed when they plan to use procedures that cause more than momentary pain and distress.

Alternate Search Required? The investigator can select Yes or No to the question “Does the protocol involve procedures which cause more than momentary pain and distress”. If the research involves procedures that cause more than momentary pain and distress (typically procedures with pain category D and E), the investigator must search for procedures that cause lesser pain and distress and provide the same research outcome. If the investigator selects Yes the investigator can then provide details about the databases searched. If the investigator selects No the investigator does not have to provide any information about alternate database searches and can save and move on to other protocol sections.

 

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The system makes it mandatory for the investigator to select Yes or No for the question “Does the protocol involve procedures which cause more than momentary pain and distress” prior to submission of the IACUC protocol. If a value is not chosen, a data validation error is generated by the system when the investigator tries to submit the protocol.

Figure 1309 Protocol Document, The Three R’s – Alternate Search Required

Table 487 Protocol Document, The Three R’s, Alternate Search Required

Field

Description

Does the protocol involve procedures which cause more than momentary pain and distress

Select one of the following choices:  Yes/No.  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.

 

Alternate Searches: This section becomes visible when the investigator responds Yes to the question “Does the protocol involve procedures which cause more than momentary pain and distress”. It allows the investigator to provide detailed information about the databases they searched, the keywords used in the search and additional details.

 

 

 

 

Figure 1310 Protocol Document – The Three R’s – Alternate Searches

Table 488 Protocol Document, The Three R’s, Alternate Searches

Field

Description

Date

Required field. Enter or select the date the database search was performed. Click the calendar icon to select, or type in mm/dd/yyyy format to populate the box with the desired date.

Databases

Required field. Specify the databases you performed a search on for less painful procedures

 

•      Select the databases from the list of databases in the Available panel. After selecting a database name, use the right pointing arrow  to move the database from the Available panel to the Selected panel. To deselect a database that is within the Selected panel, select it and use the left pointing arrow  to move the database name from the Selected panel back to the Available panel.  An investigator can select multiple databases.

 

•      You can manually enter database names that are not in the Available panel. Enter the database name in the Other   data entry box. Click the add  button and the database name entered in the Other data entry box will appear in the Selected panel. Once the database name appears in the Selected section, use the left pointing arrow  to deselect and move it to the Available panel OR use the use the right pointing arrow  to move the database from the Available panel to the Selected panel

 

 

Years

Required field. Specify the publication years or date range that the literature search was performed against. To enter the years searched or the date range, 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. 

Keywords

Required field. Specify the keywords that were used in performing the database search. To enter the keywords, 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. 

Comments

Provide a summary of the database search performed and describe whether less painful procedures were found and if so reasons for using or not using the less painful procedures. To enter comments, To enter the years searched or the date range, 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. 

Action

Required.  Click the add  button after you’ve made your selections to cause the database to be added as a numbered row in the table below.  For previously added database lines, click delete to remove the line, if needed.

link.png  For more information about basic line item functionality, see “Common Line Item Operations” in Common E-Doc Operations.