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| Protocol
Activation |
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All
CTSU members receive notification via the CTSU bimonthly broadcast
email when a study is activated by the CTSU. The broadcast email
directs the user to the CTSU Registered Member Web Site where
the protocol and relevant protocol documents are located. If a
member of a clinical site is interested in participating in the
protocol, he or she should:
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Link
to the CTSU Registered Member Web Site.
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Select the appropriate protocol from the Document Center located
in the Protocols section of the web site. This leads to the
protocol-specific web page, which provides a logistical overview
of the study and a link to the protocol-specific documents available
for download. Canadian sites link to a Canadian version of the
protocol-specific web page and associated documents provided
that study has been approved for Canadian participation by Health
Canada.
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Download
the protocol and associated materials.
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Consult
the protocol-specific notes on the web page to determine if
any materials for the protocol must be ordered from the CTSU,
the lead Group, or other entity (e.g., Quality of Life booklets,
specimen kits). If so, order the necessary documents per instructions
in the CTSU logistical appendix of the protocol.
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Select
and print the protocol-specific site registration materials
from the web page.
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Obtain
local IRB approval for participation in the study.
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Complete
protocol-specific site registration materials.
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Submit
protocol-specific site registration documents to the CTSU Central
Regulatory Office.
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Receive
confirmation of protocol-specific site registration from the
CTSU Central Regulatory Office prior to patient enrollment.
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| Protocol
Amendment Notifications |
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Changes
to a protocol, usually called amendments, may be initiated only
by the sponsoring Cooperative Group. Site implementation of an amendment
may not occur until the site has received local IRB approval. If
the amendment is issued to safeguard patients from imminent danger,
then it may be implemented immediately. This would be specifically
stated in the sponsoring Cooperative Group's cover letter. It is
critical that the site submit protocol amendments (and revised informed
consent forms, if appropriate) to their IRB within the timeframe
requested by the sponsoring Cooperative Group (usually 90 days,
if not an administrative change). If the amendment specifies whether
expedited or full board review is most appropriate, the site should
take this into consideration when presenting the amendment to the
local IRB. (The CTSU does not submit protocols or amendments to
IRBs.)
Amendments,
revisions, and memoranda of an administrative nature that are issued
by the Cooperative Groups do not prompt an urgent email to CTSU
members. Changes associated with these updates are posted on the
CTSU Registered Member Web Site and notification is sent to CTSU
members via the bimonthly broadcast email.
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| Urgent
Notifications and Serious Adverse Events |
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Under rare circumstances a Cooperative Group may issue a high priority
broadcast addressing a critical and time sensitive patient safety
or drug supply issue. The CTSU will respond by either releasing
an urgent broadcast email to the entire CTSU membership or a targeted
email to those clinical sites registered to participate in the trials
affected by the announcement.
During
the course of a trial, the sponsoring Cooperative Group will issue
numerous safety reports as received from the agent's sponsor. If
the Group deems the report critical, the CTSU will disseminate the
report as described in the paragraph above. If the Group determines
that the report does not require immediate processing, it is posted
on the Drug Safety Notifications table of the CTSU Member Web site
and released as part of the upcoming CTSU bimonthly broadcast. In
the case of all safety reports, patient status should be assessed
immediately and the protocol should be consulted for appropriate
medical management of patients. The notification must also be forwarded
to your local IRB/REB.
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| Protocol
Suspension or Closure |
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In
most cases the sponsoring Cooperative Group will provide advance
notice if a study is to close to further enrollments. The CTSU will
document the suspension or closure on the member Web site and the
upcoming bimonthly broadcast. If study suspension is immediate (in
response to a major safety or unexpected drug supply issue), a targeted
email will also be sent to participating investigative sites.
All
membership broadcasts, targeted emails, and bimonthly broadcast
email messages provide a link to the CTSU Registered Member Web
Site where the member can locate the protocol and relevant protocol
documents. The email messages also provide guidance indicating the
type of IRB review for local IRBs (full board or expedited) based
on the recommendations of the sponsoring Group.
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