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Participant Protocol Registration

SOP #: ADCR-2

Next Review Date: 06/2012

Version #: 1.1

Review Interval Period: Annual

Approved Version #: 1.1 Date: 06/2011

Policy Reference: NA

Purpose: To identify the steps to register a participant on a CCR protocol with the Central Registration Office (CRO).
STEP 1: Access the CCR Central Registration Office (CRO) 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 NCI Central Registration Office at ncicentralregistration-1@mail.nih.gov. CRO hours of operations:  8:30am-5:00pm, Monday-Friday
    • For registrations after hours, the registration will not be processed until the following business day.
    • Note: Not for "Special Exemption" protocols.
STEP 2: Click on Branch to Access an Index of Open Protocols per Branch
  1. Click on the desired protocol number to access the Protocol Registrationform.
    • The protocol registration form includes the participant demographic information and the protocol eligibility criteria questions.
    • Special Exemption protocol registration is accessed here.
STEP 3: Complete the Protocol Registration Form
  1. Verify the protocol accrual ceiling has not been reached.
  2. Print a copy of the Protocol Registration form and complete form.
    OR
    Open the Protocol Registrationform, complete online, and print.
    • All responses must be complete and accurate for the registration to be processed by the CRO Staff.
    • Signature on Protocol Registration form by team signifies that the information has been verified by the team member.
    • Registration should occur within one business day of the participant signing the informed consent document.
    • If registering a participant from an institution other than the NCI, list the name of the registering institution in the Patient Information section.
STEP 4: Fax the Completed Protocol Registration Form to the NCI Central Registration Office
  1. Fax the Protocol Registrationform 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.
STEP 5: Review of Protocol Registration Form for Completeness and Accuracy
  1. The CRO will review the Protocol Registration form for completeness and accuracy.
  2. If the Protocol Registration form is complete and accurate, the Clinical Center pharmacy will be informed of the registration by the CRO for NCI patients and drug will be released.
  3. If the Protocol Registration form is incomplete or inaccurate, the CRO will contact the team member to resolve the issue(s). The Pharmacy will not be notified of registration until the issues are resolved.  No drug will be released until that time.
    Note: The Clinical Center pharmacy will only be contacted for NCI patients on treatment studies.
STEP 6: Confirmation of Registration Will Be Sent to the Study Team Member
  1. A confirmation e-mail including Verification of Registration form, will be sent to the team member who registered the patient acknowledging the patient has been registered and the Clinical Center pharmacy has been informed.
  2. Multi-Institutional Studies where the CCR is the Coordinating Center: When patients are directly registered with the CRO by outside sites, the site will be sent a confirmation email. The sites will be responsible for informing their pharmacies.
  3. Randomized Studies: The randomized treatment assignment will be provided on the Verification of Registration form.
  4. Masked studies: The sequence number will be provided on the Verification of Registration form.
Last updated by Richman, Michele (NIH/NCI) [C] on Oct 31, 2014