Data Driven Strategies for Improved Site Activation | Page 11

Detailed and consistent data are therefore
available for forecasting. While some time
savings may occur during negotiations for
contract language and budgets because of
familiar working relationships, sites cannot
be forced to deviate from their SOPs during
start-up. So, additional time savings cannot
be realized, but the study timeline can be
forecast to appropriately reflect the reality
of the sites’ processes.
At a high level, sites can be grouped into three
to five major classes based on common features
of their start-up process. Figure 7 illustrates
one approach, using three classes. Central EC/
IRBs often take less time to approve ethics
applications and can be engaged in parallel
with site contract and budget negotiations,
while local EC/IRBs may meet less frequently
and only review protocols after certain other
steps have been taken, such as agreement on a
budget or departmental protocol review. Local

Figure 7. The site structure can affect the start-up timeline. This information is incorporated into

IRB sites can have multiple review committees

the forecasting model to help anticipate the time required for all sites to be active

that review the study before it is reviewed by
the EC/IRB, including departmental, pediatric,
gene therapy, radiotherapy, and other review
committees. Busy local EC/IRBs understandably
do not want to invest time in reviewing a
protocol. Thus, while parallel EC/IRB review
and contract and budget negotiations can save
considerable time compared to serial reviews,

At a high level, sites can be grouped
into three to five major classes based on
common features of their start-up process.

they require a larger investment of resources
for sites that may never be recouped.

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