November 2024 SOCRA Source Journal - Journal - Page 48
a study (see Table 3). The
Sponsor should communicate
their preferred method of
documentation prior to
enrollment.
TABLE 3
Documentation of Investigational Product Accountability
Device Accountability Log
format can fall into two
categories: Combined, with
receipt, use, return, repair, and
destruction on one page OR
the logs can be separated into
two or more documents (see
Diagrams 12 & 13). The author
prefers the separate documents,
where more space is allowed
for the “Use” section, including
昀椀elds for subject ID, date of
use, start and stop times (i.e.,
exposure), name and signature/
initials of person administering
the device and comments.
•
•
•
•
Document when and how IP is used throughout the study
Required for both drug and device studies, per the regulations
Document shipment, receipt, disposition, use and return of IP
Complete logs immediately following each instance of dispensation/use
or return to ensure accurate and complete documentation
•
Documentation storage location:
o Separate from essential documents (blinded studies)
Documentation
of Investigational
Productstudies)
Accountability (i.e., Device and Drug Accountab
o Regulatory
binder (non-blinded
•
Device Accountability Log:
For all studies that involve an investigational product (IP), an accountability log is a requirement
o Format may be combined with receipt, use, and return/repair/
regulationsdestruction
and GCP guidelines.
These
serve tointo
document
shipment, receipt, disposition, use
on one page
ORlogs
separated
two documents
return of IP throughout a study (see Table 3). The Sponsor should communicate their preferred m
•
Drug Accountability Log:
documentation prior to enrollment.
o Complete a new line each time study product is dispensed and/or
received
Deviceo Accountability
Log format can fall into two categories: Combined, with receipt, use, retu
Utilize IDS system, if available
repair, and destruction on one page OR the logs can be separated into two or more documents (se
Diagrams 12 and 13). The author prefers the separate documents, where more space is allowed fo
“Use” section, including fields for subject ID, date of use, start and stop times (i.e., exposure), na
Diagram
12 and comments.
signature / initials of person administering
the device
Electronic investigational
drug systems (IDS) are used
at most clinical research sites,
including UAMS, for purposes of
documenting drug accountability
(i.e., Drug Accountability
Log). These systems are more
user-friendly and ef昀椀cient
at documenting inventory,
accountability, dispensing, and
compliance than paper logs and
allow for review, if necessary,
between and during monitoring
and auditing visits.
No matter the version of log
used, they should be completed
immediately following each
instance of dispensation/use or
return to ensure that documentation meets ALCOA+ standards
of contemporaneous, accurate
and complete.
Diagram 13
14
For unblinded studies, maintaining the IP Accountability Log
in the regulatory binder is
suggested. However, to maintain
the blind in blinded studies,
the log should be stored in a
separate location, such as the
research pharmacy for drugs or
the laboratory for devices.
48
SOCRA SOURCE ©
Electronic investigational drug systems (IDS) are used at most clinical research sites, including UAM
for purposes of documenting drug accountability (i.e., Drug Accountability Log). These systems are m
November
2024 and efficient at documenting inventory, accountability, dispensing, and compliance than
user-friendly
paper logs and allow for review, if necessary, between and during monitoring and auditing visits.
