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Remember
that study staff have most likely read the protocol more than
once. During your review, highlight the key points rather than
reviewing every aspect of the protocol.
Know
what you want to accomplish during your visit. In case you get
off track during the meeting, you can check your list of objectives
to be sure everything is covered.
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In order
to maximize the efficiency of the initiation visit, it is recommended
that as much planning as possible be done as early as possible.
Tasks include:
- Coordination
of the availability of the attendees
- Producing
an agenda for the meeting
Providing
extra copies of materials: Many centers operate with a minimal
administrative staff. By having the Sponsor provide all of the documents,
the process may be more efficient and less expensive.
Being
aware of outstanding documents: Although some documents
may not need to be available prior to the site visit, the site
may be responsible for eventually providing them to the sponsor.
It is important to make the sites aware of the importance of
these documents and expectations for their collection.
Preparing visual aids (lab kits, etc..): Visual aids can
be very useful in communicating the important aspects of the
protocol to the study staff by the sponsor. |
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Creating
a List of Sponsor objectives: The primary focus of a center
is to tend to the needs of patients which means that they may be
called away from your meeting for patient care matters. Creating
a list of objectives to use as a "tickler" during the meeting allows
added flexibility within the schedule while ensuring that all items
are covered.
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