Site ICFs

Access the study management page in one of the following ways:

On the study management page that opens, from the left pane, select ICF > ICF Listing.

Figure 3. Accessing ICF listing

On the page that opens, under the Site ICFs tab, from the workspace toolbar, select Setting .

Figure 4. Accessing site ICF listing setting

In the dialog that appears, under the Settings tab, you can view all the currently existing data elements of the site ICF listing. To add a new data element, from the workspace toolbar, select New Item .

Figure 5. Selecting to add site ICF listing data element

At the bottom of the list, in the new row added, enter the details as explained in the following table.

Figure 6. Adding new data element to site ICF listing

Once saved, the new data element is added. You can now perform the following actions to it.

Edit data element

Next to the data element you want to update, select Edit . In the fields that become editable, update the values as explained in the preceding table.

Figure 7. Editing data elements of site ICF listing

Delete data element

Next to the data element you want to remove from the site ICF listing, select Delete . Once selected, in the confirmation dialog that appears, enter the reason for deletion and select SAVE.

Important

For the Expiration Date data element, the deletion is reversible, this element can be restored.

Figure 8. Deleting data element

Restore data element

Next to the element that you want to reinstate along with all its previously recorded data in the site ICF listing records, select Restore .

Figure 9. Restoring previously deleted data element

Move data element

Next to the data element you want to move on the list to change the order, select Move and drag the row to its intended position. Once released, the element is placed and the display order numbers change accordingly.

Figure 10. Moving data element

Analyze operation history for site ICF listing configurations

Select the Operation History tab to access the log of all actions on the site ICF listing configurations for analysis purposes. Recording operation history ensures keeping track of all customizations and being responsible for them.

Figure 11. Analyzing operation history for site ICF listing configurations

Access the study management page in one of the following ways:

On the study management page that opens, from the left pane, select ICF > ICF Listing.

Figure 3. Accessing ICF listing

On the page that opens, under the Site ICFs tab, from the workspace toolbar, select New Item .

Figure 4. Selecting option to add new site ICF listing record

In the New dialog that appears, add the ICF and protocol versioning details as explained in the following table.

Figure 5. Adding new site ICF listing record details

Element	Details
ICF Name*	Enter the name of the site ICF for which you are creating the listing record.
ICF Version*	Enter the version of the site ICF for which you are creating the listing record.
Consent Method*	Select the method how the subjects of the study can give their consent for this ICF. The values can be customized to suit your study business needs, for instance, they can be Electronically or On paper, or you can add Verbally if it is acceptable.
Language*	Select the language of the site ICF.
Local/Central IRB*	Select whether the site ICF is reviewed and approved by the central Institutional Review Board (IRB) for the study or the local IRB in the region where this ICF applies.
Submission Date	Select the date when the site ICF has been submitted for review to the IRB.
ICF Approved Date*	Select the date when the site ICF version has been approved by the IRB.
Applicable Site Code*	Select the unique identifier of the site where this ICF is applicable for subjects. Note that once the site ICF listing record is saved, the site selection cannot be changed.
PI	Represents the name of the principal investigator (PI) at the site to which this ICF applies. The value is autopopulated from the site profile based on the selected site code.
Expiration Date	Select the date, if any, when the site ICF expires and becomes outdated.
Description	Enter additional details about the site ICF for other users' acknowledgment.
Related Master ICFs	In this block, select and in the dialog that opens, select the checkboxes next to the master ICFs that you want to reference to this site ICF. Figure 6. Selecting related master ICFs This block of settings is only available if you add the Reference from Master ICF data type elements to your ICF listing setting, thus enabling cross-referencing between site and master ICFs. The available properties of the master ICFs depend on the items added to the data element, such as ID, name, version, and so on.
SAVE	Select to implement the changes.
CANCEL	Select to discard the changes without saving.

Access the study management page in one of the following ways:

On the study management page that opens, from the left pane, select ICF > ICF Listing.

Figure 3. Accessing ICF listing

On the page that opens, under the Site ICFs tab, locate the record whose details you need to update. Then from the Action(s) column next to the record, select Edit .

Figure 4. Selecting to edit site ICF listing record

Tip

If your site ICF has a tracking log added, the notification appears that changing the ICF details can affect the tracking log data. Select CONFIRM to acknowledge the warning and proceed to editing.

Figure 5. Receiving notification on potential data change

In the Edit dialog that appears, update the site ICF listing record details as needed. These details are the same as the ones explained in the table of the Create new site ICF listing record section.

Figure 6. Editing site ICF listing record details

Access the study management page in one of the following ways:

On the study management page that opens, from the left pane, select ICF > ICF Listing.

Figure 3. Accessing ICF listing

On the page that opens, under the Site ICFs tab, locate the record of your interest. Then next to your record, from the Action(s) column, select Activate or Inactivate .

Figure 4. Selecting to activate or inactivate site ICF listing record

In the Reason dialog that appears, provide the arguments to justify your action. Then select .

Figure 5. Providing reason for inactivating ICF listing record

Access the study management page in one of the following ways:

On the study management page that opens, from the left pane, select ICF > ICF Listing.

Figure 3. Accessing ICF listing

On the page that opens, under the Site ICFs tab, locate the record whose references you want to check. Then from the Action(s) column next to the record, select Reference Item .

Figure 4. Selecting to view references for site ICF

In the Reference Item dialog that opens, review all the ICF tracking log records associated with the site ICF.

Figure 5. Reviewing referenced item list for site ICF

Access the study management page in one of the following ways:

On the study management page that opens, from the left pane, select ICF > ICF Listing.

Figure 3. Accessing ICF listing

On the page that opens, under the Site ICFs tab, locate the record whose history of changes you want to review. Then from the Actions column next to it, select More > Operation History .

Figure 4. Accessing site ICF listing record operation history

In the Operation History dialog that opens, review the complete history of actions performed to the ICF listing record.

Figure 5. Analyzing operation history for site ICF listing record

Access the study management page in one of the following ways:

On the study management page that opens, from the left pane, select ICF > ICF Listing.

Figure 3. Accessing ICF listing

On the page that opens, under the Site ICFs tab, locate the record you want to remove. Then from the Actions column next to it, select More > Delete .

Figure 4. Deleting site ICF listing record

In the Reason dialog that appears, provide the arguments to justify your action. Then select .

Figure 5. Providing reason for ICF listing record deletion