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Off Study Notification

SOP #: ADCR-2

Next Review Date: 08/2012

Version #: 1.1

Review Interval Period: Annual

Approved Version #: 1.1 Date: 08/2011

Policy Reference: NA

Purpose: To identify the steps to be completed to submit Off Study information to the NCI Central Registration Office (CRO).

To assist in the completion of this form, the definitions of Off Therapy date and Off Study date are provided below:

Off Therapy date: The date when the Principal Investigator determines that no further protocol-specific therapy will be administered.

Off Study date: The date when all protocol-specific activities have been completed, including the follow-up period. Once a patient is taken Off Study, there cannot be any collection of data on the patient.

STEP 1: Access the CCR Central Registration Office Homepage
  1. Enter the following URL in a browser (Internet Explorer or Firefox) to access the CCR Central Registration Office homepage: http://intranet.cancer.gov/ccr/welcome.htm,
    • For assistance, call the Central Registration Office Help Line at 301-402-1732 or email the NCI Central Registration Office at ncicentralregistration-1@mail.nih.gov

    • CRO hours of operations: 8:30am-5:00pm, Monday-Friday
STEP 2: Complete the Off Study Notification Form
  1. Click on the Off Study Notification form link.
  2. Complete the Off Study Notification form online and print (data will not be saved in form).
    OR
    Click on the print icon in the menu bar at the top of the screen to print a copy of the protocol registration form and complete.
STEP 3: Fax the Completed Off Study Notification Form to the NCI Central Registration Office
  1. Fax the Off Study Notificationform to the Central Registration Office
    • Fax number: 301-480-0757
    • Any faxes received by the Central Registration Office after 5:00pm will be processed the next business day.
    • Off Study information should be submitted within 1 business day of obtaining the information.
STEP 4: Confirmation of Registration Will Be Sent to Study Team Member
  1. A confirmation email, Verification of Registration form, acknowledging that Off Study Notificationform has been received will be sent to the team member who submitted the form.
    • Multi-Institutional Studies where the CCR is the Coordinating Center: When patients have been directly registered with the CRO by outside sites, the site will be sent a confirmation email.
Last updated by Richman, Michele (NIH/NCI) [C] on Oct 31, 2014