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An
amendment is a change to an approved clinical protocol that can
be initiated only by the sponsoring Cooperative Group. An amendment
may address changes related to patient safety, parameters, the scope
of the study, or new scientific findings. It may include minor administrative
changes, such as changes in personnel or spelling errors. The NCI
requires Cooperative Groups to implement use of a "version date"
to commonly identify protocol version changes. This date is noted
on the front cover of the protocol. Other versioning notation such
as the terms "revision" and "amendment" and all number schemes are
specific to the Cooperative Group.
When
a Cooperative Group issues an amendment, revision, or update, notification
is sent to all CTSU members via the bimonthly broadcast email. Protocol
changes that have an immediate impact on patient safety are promptly
communicated via a separate broadcast email. The CTSU follows the
instructions given by the Cooperative Group sponsoring the protocol
to determine how quickly notification of amendments is given to
sites (immediate or bimonthly broadcast email).
Proposed
changes in a research activity during the period for which IRB approval
has already been given may not be initiated without IRB review and
approval, except when necessary to safeguard patients from immediate
hazards. If the original protocol is amended, the site must forward
the amendment and supporting documentation to the local IRB for
review. If the amendment necessitates a change in the consent, the
revised consent accompanies the IRB submission documents. It is
critical that the site submit protocol amendments to the IRB within
the timeframe requested by the sponsoring Cooperative Group.
The
NCI/CTEP Clinical Trials Monitoring Branch (CTMB) guidelines state
that an amendment should be submitted immediately to the IRB and
an approval obtained within 60 to 90 days. It is critical that the
site submit protocol amendments to the IRB within the established
guidelines outlined by NCI of 60 to 90 days. The Cooperative Group
leading the trial may require that proof of IRB approval be submitted
to the CTSU Central Regulatory Office within a specified timeframe
(generally 90 days) to continue patient enrollment privileges. Sites
are responsible for following the guidance provided by the Cooperative
Group leading the trial.
The
text of a protocol amendment often includes recommendations from
the sponsoring Cooperative Group as to the type of IRB review and
approval that is needed. If the amendment specifies whether expedited
or full board review is most appropriate, the CTSU site should take
this into consideration when presenting the amendment to their local
IRB. The immediate email and the bimonthly broadcast email that
notifies the site of the amendment will also provide information
about the required type of IRB review (Full Review or Expedited
Review). On occasion, the lead Group will require that the site
provide proof of IRB approval within a specified timeframe to continue
enrollment of patients. CTSU will communicate to the sites any specific
instructions for submitting proof of IRB approval of an amendment.
Once
the local IRB has approved the amendment, consent form, and any
other related documents, the documentation of IRB approval and the
IRB-approved materials must be kept in the site's regulatory files
for verification at the time of audit. In some cases, the CTSU requires
proof of IRB approval and a copy of the new IRB-approved materials
(e.g., informed consent form) before patient enrollment can continue.
The CTSU will follow the instructions given by the Cooperative Group
sponsoring the protocol to determine when the additional materials
are needed. The amended protocol documents will be available from
the CTSU Registered Member Web Site.
Click
to learn more about protocol amendments.
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