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)
- 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.