Purpose: To provide the steps necessary to change a patient's protocol number in CRIS.
STEP 1: Log into the Clinical Research Information System (CRIS)
Log into the CRIS system.
Staff will have to have completed CRIS training and apply for a CRIS account/password.
The NCI-CCR Central Registration Office staff will need to obtain access rights to CRIS through the Office of the Clinical Director’s Deputy Clinical Director.
STEP 2: Search for Patient
Click on the Find Patienticon.
The icon symbol is a man with a magnifying glass.
Enter Patient’s Identifying Information (Name or MR#)
Tabs located at top of the screen allow searches using other patient data (medical record number, provider, etc.).
STEP 3: Click on the Order Entry Worksheet Icon
The Order Worksheeticon is located in the upper-left section of the screen and in the task bar located at the top of the screen.
The symbol is a clipboard with a pen.
The types of requests that may be made via this order:
Change a patient’s primary protocol (visit reason in CRIS)
Removal from any protocol (primary protocol and/or additional protocol(s)
Addition to any protocol
STEP 4: Enter Data in the Order Entry Worksheet Screen
In box listing "Type here to enter order name" type in "Change".
Change from Protocol assignment will appear under Order entry worksheet.
Click on "Change Protocol Assignment: NCI" from the change pick list.
Click on "Add" button.
NCI Change Protocol Assignment screen will appear.
STEP 5: Enter Data in Change Protocol Assignment Screen
To removea patient from a protocol:
Mark the box "Remove Patient From Protocol".
Complete the Protocol Identification by entering the protocol’s full year (e.g., 2002).
Use the pick list to locate the desired protocol number (e.g., 2002-C-0083).
Use pick list to find reason for removal.
Select "reassignment to another protocol".
If patient is on a screening protocol, leave this section blank.
If patient has been on previous studies, select the most recent protocol to re-assign in CRIS.
The effective date is the patient’s off-study date from their most recent protocol.
To adda patient to a protocol:
Mark the box "Add Patient to Protocol".
Locate the protocol number by using the pick list (e.g., 2005-C-0232).
Pick reason for addition (e.g., new accrual).
Effective date is the consent date to the new assigned protocol.
To changea patient’s current primary protocol:
Mark the box "Change Current Primary".
Locate the protocol number by using the pick list (e.g., 2001-C-0129).
Reason for change - pick "Other".
Effective date is the registration date to the new protocol.
Use pick list for status of previous (maintain as secondary).
Enter any Special Instructions.
Click the "OK" button.
The completed Order Entry will appear.
Double-click on order to final review, if desired.
Click on the "Submit" button to submit order.
A service requisition will print in the Medical Record Department for processing.
STEP 6: Processing the Protocol Reassignment Order
The Protocol Assignment will be updated in CRIS by the Clinical Center (CC) Medical Record Department staff.
The protocol assignment will be updated within 24 hours of submission.
The CRIS order will be completed.
Contact the CC Medical Record Department with questions regarding this process at 301-496-2292.