The document discusses how Veracity Logic's Interactive Response Technology (VLIRT) can be used to manage protocol deviations using authorization codes. It describes setting up authorization codes to be used for subjects outside an age range or for recording activity outside a predefined window. It shows how the system prompts for an authorization code in these situations and generates a report afterward listing the codes used, subjects, and reasons. Contact information is provided for any questions.

1. 11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston
Chapel Hill, NC 27517 Email: info@veracitylogic.com
Managing
Protocol
Devia0ons:
Authoriza0on
Codes
using
Veracity
Logic’s
Interac0ve
Response
Technology
(VLIRT®)

2. 11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston
Chapel Hill, NC 27517 Email: info@veracitylogic.com
SeEng
Up
Authoriza0on
Codes
• Define
when
Authoriza0on
Codes
(Auth
Codes)
will
be
used
– Subject
out
of
age
range
– Recording
ac0vity
out
of
‘hard’
window*
• Provide
an
ini0al
set
of
authoriza0on
codes
to
a
medical
monitor
and
a
back-­‐up
– The
medical
monitors
can
keep
copies
of
the
authoriza0on
codes
in
their
wallets
so
they
have
them
when
site
users
call
*
A
‘hard’
window
is
defined
as
an
ac2vity
window
that
requires
authoriza2on
from
a
medical
monitor
before
the
ac2vity
can
be
recorded.

3. 11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston
Chapel Hill, NC 27517 Email: info@veracitylogic.com
Using
Auth
Code
for
Age
Range
• Enter
Subject
Informa0on:
• For
this
project
we
were
collec0ng
only
Birth
Year
and
Age
• Note:
reason
Authoriza0on
Code
is
required
is
shown

4. 11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston
Chapel Hill, NC 27517 Email: info@veracitylogic.com
Using
Auth
Code
for
Ac0vity
Out
of
Window
• Confirm
Subject
ID
• System
prompts
for
Auth
Code
for
ac0vity
outside
‘hard’
window
• Enter
Auth
Code
to
record
the
ac0vity
• Note:
reason
Authoriza0on
Code
is
required
is
shown

5. 11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston
Chapel Hill, NC 27517 Email: info@veracitylogic.com
Repor0ng
Auth
Code
Usage
• At
the
end
of
the
study,
a
report
can
be
generated
showing
the
Authoriza0on
Codes
used,
the
subjects
they
were
used
for,
and
the
reason
they
were
used

6. 11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston
Chapel Hill, NC 27517 Email: info@veracitylogic.com
Ques0ons?
• If
you
have
ques0ons
about
how
you
can
take
advantage
of
using
authoriza0on
codes
to
manage
protocol
devia0ons
for
your
project,
email:
• David
Goldston
info@veracitylogic.com