August 2024 SOCRA Source Journal - Journal - Page 39
outsource mostly all functional
responsibilities. Thus, CRO
employees must understand
the functions that they are
contracted to do and who is
responsible for each task. The
TOO identi昀椀es who is taking
ownership of each piece of the
clinical trial.
The CRO is involved in
selection of clinical research
sites to participate in the
clinical trial, typically starting
with the feasibility process.
The study start-up team uses
a company database and
other resources to send a
study-speci昀椀c questionnaire
to potential investigators
to gauge their interest and
determine initial suitability.
The CRO usually sends a
con昀椀dentiality agreement with
the questionnaire. Upon receipt
of the signed con昀椀dentiality
agreement, the CRO sends the
sites the protocol synopsis.
Each clinical research site’s
responses to the questionnaire
are used to determine if the
CRO will continue to consider
them in the selection process.
The questionnaire covers a
variety of aspects that would
deem a site as quali昀椀ed,
such as investigator and staff
experience, the number of
patients the clinical research
site can enroll, and whether
they have the appropriate staff
and equipment to conduct the
clinical trial.
The CRO and the sponsor then
review the clinical research sites
that are interested and seem
suitable to determine which
sites to select to participate in
the clinical trial. The sites that
are chosen usually represent a
mix of countries, with a certain
number of sites per country.
The next steps are a Clinical
Trial Agreement between each
site and the sponsor, budget
negotiation based upon the
sponsor-established template,
and site quali昀椀cation visits
conducted by clinical monitors.
If a CRO is not used, the
sponsor would manage these
tasks themselves.
Expectations of Clinical
Research Sites
After the clinical research sites
are noti昀椀ed of their selection,
the clinical monitor activates
each site after successful
completion of a site initiation
visit (SIV). The clinical monitor
ensures that the sites are
completely trained and that
any necessary systems and
equipment are available and
working properly. The site
initiation visit usually occurs
after the following activities
have been completed:
•
•
•
•
Signed contract
Executed budget
Clinical trial supplies have
been sent to the site
Access to relevant systems
has been granted to site
personnel
•
Institutional review board
(IRB) approval has been
obtained.
At the conclusion of the site
initiation visit, the site receives
approval to begin recruitment
of patients for the clinical trial.
Activation also triggers the
investigational product to be
shipped to the site.
Table 5 provides an overview of
expectations of clinical research
sites. IRB or independent ethics
committee (IEC) approval is
necessary before a site can
recruit participants, and it
is preferred before the site
initiation visit. IRB or IEC
approval and reporting enables
an overseeing body to ensure
that safety is the utmost priority
for enrolling participants into a
clinical trial.
Every clinical research site has
to submit to either a local IRB,
a central IRB, or they use a
central IRB for local submission
purposes when the trial itself
is not using centralized IRB
TABLE 5
Expectations of Clinical Research Sites
•
•
•
•
•
•
•
•
Obtain IRB approval and updates
Maintain regulatory documentation
Sign a con昀氀ict-of-interest form
Investigator responsibilities:
o Follow Good Clinical Practice
Site staff expectations:
o Form FDA 1572 - Section 9: Commitments
o 21 CFR 312.60-312.70
o Ensure site staff are aware of patient con昀椀dentiality
Good Documentation Practices
Safety reporting:
o Adverse events
o Serious adverse events
Study close-out
SOCRA SOURCE © May 2024
39