Clinical Research Operations

How to Change a Protocol Number in CRIS

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)

1. 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

1. Click on the Find Patienticon.
   • The icon symbol is a man with a magnifying glass.
2. 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

1. 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

1. In box listing "Type here to enter order name" type in "Change".
   • Change from Protocol assignment will appear under Order entry worksheet.
2. Click on "Change Protocol Assignment: NCI" from the change pick list.
3. Click on "Add" button.
   • NCI Change Protocol Assignment screen will appear.

STEP 5: Enter Data in Change Protocol Assignment Screen

1. 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.
2. 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.
3. 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).
4. Enter any Special Instructions.
5. Click the "OK" button.
6. The completed Order Entry will appear.
7. Double-click on order to final review, if desired.
8. 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

1. 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.