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PATIENT
REGISTRATION
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Upon completion of the forms, fax these forms to the CTSU Patient Registrar. CTSU Patient Registrar Hours of Operation will be 9 AM – 5:30 PM, Eastern Time, Monday – Friday (excluding holidays). Registrations received after 5:00 PM will be processed the next business day. Continue to fax patient registrations to 1-888-691-8039. For time of need CTSU patient enrollments, call 301-704-2376, 9AM – 5:30 PM.
If
the CTSU Patient Registrar receives notification that a registration is
forthcoming and the forms are not received within 24 hours, the CRA/Research
Nurse is contacted to ascertain the status of the registration or to request
resubmission of the forms. Upon receipt of the patient's registration
materials, the CTSU Patient Registrar confirms that the Investigator has
been registered and credentialed by the CTSU, and that protocol-specific
site registration is complete. The CTSU Patient Registrar reviews the
patient enrollment documents to assure that all required forms are submitted
and completed. If there are any errors or if additional information is
needed, the CTSU Patient Registrar immediately contacts the Investigator
or designee at the site to resolve the issue. The
CTSU Patient Registrar then contacts the appropriate Cooperative Group
to enroll the patient on the study. The Cooperative Group assigns a unique
patient study identification number for each enrollee. If specified by
the protocol, a treatment or randomization assignment may also be made
at this time. Randomization refers to the random assignment of patients
into one of two or more treatments for the purpose of comparing the treatments
on a predetermined outcome measure(s). Randomization gives each patient
equal opportunity to be placed on any of the arms of the study to preserve
study integrity by minimizing systematic differences between groups other
than the treatments being compared. Certain protocols require randomization
to occur at a later point in time, i.e., after a specific time interval,
cycle, or course of treatment. The
CTSU Patient Registrar phones the CRA/Research Nurse at the site within
24 hours to relay the patient study identification number and treatment
assignment (if provided). The Group-assigned unique patient study identification
number must be used on all correspondence and Case Report Forms. The
CTSU Patient Registrar follows this phone call by sending a confirmation
of registration fax as documentation of the registration. The confirmation
of registration may be a forwarded communication sent to the CTSU by the
Cooperative Group conducting the study or it may originate from the CTSU.
The CRA/Research Nurse should receive the fax within 24 hours of patient
enrollment and randomization, respectively. Copies of the fax confirming
registration should be retained by the site and by the CTSU.
Enrollment processing for the following Group’s studies are limited to the Group’s hours of operation:
CALGB - 9AM to 4:15PM, ET
RTOG – 9AM to 4:30PM, ET
NCCTG- 9AM to 4:30PM, ET (except N0147, online)
MDA- 9AM-3:45PM, ET