The first step in management is choosing suitable sites for the study. During the selection process, various factors are taken into consideration, including the patient population, prior experience, site infrastructure, and regulatory compliance.
The selection of a site
marks the start of
the initiation
process. Getting
regulatory approval
, educating site
staff about the
protocol and study
procedures, setting
up equipment, and
making sure all
relevant paperwork
is in order, are the
part of this proces.
The selection of a site
marks the start of
the initiation
process. Getting
regulatory
approvals,
educating site
staff about the
protocol and study
procedures, setting
up equipment, and
making sure all
relevant paperwork
is in order, are
the part of this
process.
Monitoring the outgoing
trial involves making
routine visits to
ensure that the study
is carried out in
accordance with the
protocol and GCP
requirements. Source
documents, collected
data, participant
eligibility and safety,
are also validated.
At the end of a
clinical trial, site
closeout activities
take place.
This includes
completing data
collection, making sure
all necessary paperwork
is submitted, returning
study materials, and
visiting study sites
one last time.Site
closeout activities
also include archiving
study-related documents
for future reference.
The goal of Site
Management is to
help minimize trial
time and expense,
which will produce
more efficient and
accurate results.
The tasks covered
by Prime Services
include:
- Creating Documentation.
- Managing patient recruitment.
- Managing and completing hiring and staffing needs.
- Identifying and/or managing investigators and sub-investigators.
- Preparing Institutional Review Boards (IRB) submissions.