Register
OBJECTIVE 5: PATIENT REGISTRATION AND ENROLLMENT
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Module Objectives |
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1
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Summarize CTSU pre-registration information for Cooperative Group members |
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2
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Initiate CTSU registration of Cooperative Group members |
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3
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Explain the qualification process whereby investigators not affiliated with a Cooperative Group can be credentialed as CTSU members |
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4
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Identify the protocol-specific registration process and regulatory requirements that enable a site to participate in a clinical trial through the CTSU |
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5
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Define the sequential steps in the patient registration process |
PATIENT REGISTRATION
The following forms are required for patient registration:
Upon completion of the forms, notify the CTSU Data Operations Manager by telephone that a registration is forthcoming. Patient registration forms should be faxed to the CTSU Data Operations Manager between the hours of 8:00 am and 4:30 pm EST, Monday through Friday.
If the CTSU Data Operations Manager receives notification 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 patient's registration materials, the Data Operations Manager confirms that the investigator is registered with and credentialed by the CTSU, and that protocol-specific site registration is complete. The Data Operations Manager 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 Data Operations Manager immediately contacts the investigator or designee at the site to resolve the issue.
The CTSU Data Operations Manager contacts the appropriate Cooperative Group to enroll the patient on the study. The Cooperative Group assigns a unique patient study identification number. If specified by the protocol, a treatment or randomization assignment may also be made at this time. Randomization refers to the random assignment of participants 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. Randomization prevents the existence of 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 Data Operations Manager contacts the CRA/Research Nurse at the site by telephone within 24 hours to relay the patient study identification number and treatment assignment (if provided). The patient ID must be used on all correspondence and Case Report Forms.
The CTSU Data Operations Manager follows this phone call by sending a CTSU confirmation of registration fax as documentation of the registration. The fax 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 should be retained by the site and by the CTSU.