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How to Change a Protocol Number in CRIS

SOP #: ADCR-3

Next Review Date: 08/2013

Version #: 1.2

Review Interval Period: Biennial

Approved Version #: 1.2 Date: 08/2011

Policy Reference: NA

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.
Last updated by Richman, Michele (NIH/NCI) [C] on Oct 31, 2014