November 2024 SOCRA Source Journal - Journal - Page 47
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•
•
•
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Use “one-size-昀椀ts-all” only
for recurring oversight/
erroneous practice
Include subject and protocol
IDs
Explain clearly and
speci昀椀cally the error/
omission/discrepancy
Include any corrective
action or follow-up, when
applicable
NTF should be initiated/
authored by the person
responsible for its content
(coordinator, research
nurse, pharmacist, clinical
investigator, etc.)
File with related documents
in subject 昀椀le or behind
appropriate study binder
tab
Often, a nurse or study
coordinator needs to call
subjects to give or gather
information, such as how to take
the study drug as prescribed or
to follow up on AEs. The source
(the 昀椀rst place something is
recorded) documentation of
these conversations can be
achieved through either paper
or electronic methods but
should be done in a way that
routinely captures all relevant
information to allow for an audit
trail that can be followed by
monitors and auditors when
reviewing 昀椀les. The Phone
Call Summary Template is an
ideal document for use in this
situation (see Diagram 11).
Documentation of
Investigational Product
Accountability (i.e., Device
and Drug Accountability)
For all studies that involve
an investigational product
(IP), an accountability log
is a requirement per FDA
regulations and GCP guidelines.
These logs serve to document
shipment, receipt, disposition,
use and return of IP throughout
Diagram 10
Our best practice recommendations for use of NTF:
• Print on letterhead
• Generate on a case-by-case basis
Diagram
11
• Use “one-size-fits-all”
only for recurring
oversight / erroneous practice
• Include subject and protocol IDs
• Explain clearly and specifically the error / omission / discrepancy
• Include any corrective action or follow-up, when applicable
• NTF should be initiated / authored by the person responsible for its content
nurse, pharmacist, clinical investigator, etc.)
• File with related documents in subject file or behind appropriate study bind
Often, a nurse or study coordinator needs to call subjects to give or gather informat
take the study drug as prescribed or to follow up on AEs. The source (the first place
recorded) documentation of these conversations can be achieved through either pap
methods but should be done in a way that routinely captures all relevant informatio
trail that can be followed by monitors and auditors when reviewing files. The Phon
Template is an ideal document for use in this situation (see Diagram 11).
Documentation of Investigational Product Accountability (i.e., Device and Drug
For all studies that involve an investigational product (IP), an accountability log is a
regulations and GCP guidelines. These logs serve to document shipment, receipt, dis
return of IP throughout a study (see Table 3). The Sponsor should communicate their
documentation prior to enrollment.
Device Accountability Log format can fall into two categories: Combined, with rece
repair, and destruction on one page OR the logs can be separated into two or more do
Diagrams 12 and 13). The author prefers the separate documents, where more space
13
“Use” section, including
fields SOURCE
for subject ID,
date of use, start
and stop 47
times (i.e., e
SOCRA
© November
2024
signature / initials of person administering the device and comments.
