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Upon receipt of IRB approval, submit protocol-specific site registration
documents to the CTSU Central Regulatory Office in Philadelphia. |
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Consult
protocol-specific notes (on protocol-specific web page) and order
any protocol-specific items (e.g., Quality of Life forms) that are
not available from the CTSU website. |
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Initiate
meeting to educate staff about the specific details of the protocol.
This will ensure successful management of the protocol, which will
result in credible data. Take meeting minutes to document attendees
and the information presented. (Note: The study coordinator may conduct
additional educational sessions if it is determined that staff need
more information about the protocol.) |
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Copy
the IRB-approved informed consent form and have it available for the
research team to provide to potential study participants. |
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Prepare
for lab collections, as appropriate. (NOTE: Do not collect specimens
until the patient has signed the informed consent form.) Ensure that
packaging and shipping found in the protocol are followed. |
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Determine
the population that is appropriate for the protocol. |
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Evaluate
patient's eligibility using the inclusion/exclusion criteria.
Patient
Registration Procedure
Registration
is the process of entering a patient onto the study. Once the inclusion/exclusion
criteria are reviewed for a patient and it is determined that the
patient meets the criteria, the following activities must occur
in order to successfully register a patient into a study:
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 Obtain
Informed Consent: Every effort must be made to protect
the rights of the study patients. An Investigator may not
involve a patient in research (including tests to evaluate
eligibility) unless the Investigator or his or her representative
has obtained informed consent signed by the patient. An Investigator
should ask for such consent only under circumstances that
provide the prospective participant sufficient opportunity
to consider whether or not to participate. Obtaining informed
consent is more than getting a signature on a form; it is
a process designed to:
- Provide
the patient with current and ongoing information about the
study;
- Ensure
that the patient understands the information that has been
presented and has an opportunity to ask questions;
- Discuss
the patient's rights as outlined in the consent;
- Allow
the patient the opportunity to accept or decline to participate;
and
- Allow
the patient the opportunity to freely withdraw from the
study at any time.
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Ensure
Confidentiality: The confidentiality of the patient must
be protected. All records will be maintained in a secure environment.
Clinical information may not be released without the written
permission of the patient or legal guardian for minors, except
as necessary for monitoring by the FDA, pharmaceutical sponsors,
representatives of the NIH, NCI, CTSU, or Cooperative Group
auditors. The informed consent document should list all the
research team members who may have access to clinical information.
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Obtain
Patient Authorization (Health Insurance Portability and Accountability
Act): All U.S. institutions that meet the definition of
"covered entities" must obtain a patient authorization for
release of protected health information. The CTSU and the
Cooperative Groups have provided guidance documents and, in
some cases, sample authorization forms for use by the sites.
HIPAA-related documents are available on the CTSU Registered
Member Web Site by accessing the Resources tab and then through
the protocol-specific site registration documents. Also, a
separate area about HIPPA exists in the Resources tab.
Please
note that the CTSU and its associated contractors are not
considered covered entities or business associates as defined
by the HIPAA legislation. Neither CTSU nor its associated
contractors are obligated to participate in business agreements
with individual institutions.
For
additional information on the HIPAA legislation please see
the following links:
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Determine
Eligibility: Once a patient is identified as a potential
candidate for a study and the informed consent for the protocol
is obtained, the screening (or pre-entry or pre-treatment)
to evaluate eligibility begins. This eligibility evaluation
may include laboratory and/or clinical tests. The results
of the tests determine whether or not the patient satisfies
the inclusion/exclusion criteria of the protocol. All screening
evaluations are performed prior to registering the patient
on the protocol.
After
the eligibility evaluation is complete, use the protocol-specific
Eligibility Checklist to document that the participant fulfills
the inclusion/exclusion criteria of the protocol. If the patient
is eligible for the protocol, complete the study enrollment
forms to register the patient. The Eligibility Checklist and
study enrollment forms are available from the CTSU Registered
Member Web Site. Download and complete these forms prior to
contacting the CTSU to register the patient.
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Register
Patient: When the site is ready to register a patient, the CRA/Research Nurse notifies the CTSU Patient Registrars. 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.
Click
to learn more about the patient registration process.
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