Clinical Trial Toolkit for Clinical Researchers
Summary Sheet
Title:
Purpose:
N2-FHA SOP
Details:
Investigational Drug Accountability Log: Pharmacy/Site Drug Supply Record
To document all study site drug disposition and accountability.
Use with N2 SOP 010_05
The accountability log should depict a complete and accurate record of how the
drug was received, dispensed, and disposed of, including quantities used and
final disposition.
The column headings indicated on the log template below are only suggestions
and may be modified to meet study needs.
Rules &
Regulations
Best Practice
Recommendations:
Version 1.0: 2014 03 06
HC Guide - 0068 items 8.2.14 and 8.2.15 require documentation to ensure
proper storage, packaging, dispensing and disposition of investigational products
and trial-related materials.

Update and complete the log as study drug is dispensed and/or received,
to ensure comprehensiveness and accuracy of the data. A new line
should be completed each time study drug is dispensed and/or received.

The Investigational Drug Accountability Log may be used to record
overall supply study product supplies and accountability. A separate log
called “Subject Record” may be used to record the dispensation and
return of study drug on a subject by subject basis.

Ensure that the first section of the log is completed to include the name
of the institution, Investigator name, product name, etc. This will
minimize the potential for errors and entering data into the wrong
record.

In the “Quantity Dispensed and/or Received” column, use a ‘+’ before
the number when receiving drug; use a ‘-’ before the number when
dispensing drug. See the example provided below within the log.

In the “Balance Forward” column, use the diagonal line across the box to
record the previous balance forward / the resulting balance, e.g. 500 /
600. See the example provided below within the log.

The record keeper should initial the line item as the information is
entered. Ensure all record keeper information is recorded on the task
distribution list or on a site delegation log.

Create additional lines and pages as required.

For non blinded clinical studies maintain this log in the Essential
Documents Binder, behind the ‘Study Drug Records’ tab. (Synonyms for
this binder include Investigator Binder, Regulatory Binder, Investigator
Site File (ISF), and Study File.)

It is recommended, for blinded clinical studies, that study drug
accountability records be filed in a separate location (e.g., the research
Page 1 of 3
pharmacy) so blinding can be maintained.

Number each log page and store pages in reverse chronological order,
with the newest pages of the log placed at the front of the section.

At the conclusion of the study, identify the final page of the log by
checking the box in the footer.

Remove this Summary Sheet before using this log.
Log Revision History:
Version
Number
Date
Summary of Revisions Made:
1.0
14Mar2012
First approved version of Stock Record log
References:
1. This document has been developed using resources made publicly available through the
generosity of the National Institute of Dental and Craniofacial Surgery – an Institute of the
U.S. National Institutes of Health. Accessed March 6, 2014 @
2. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/docs/gui_68-eng.php
3.
http://www.google.ca/url?sa=t&rct=j&q=investigational+product+accountability+log+lifespan&source=
web&cd=1&cad=rja&ved=0CDMQFjAA&url=http%3A%2F%2Fwww.lifespan.org%2Fdoc%2FPage.asp%3
FPageID%3DDOC022945&ei=AXRwUdCmGYe9iwLu3oCoCg&usg=AFQjCNEpBIlfrX_usR5QT1gCSWxckeUX
8w&bvm=bv.45373924,d.cGE
Version 1.0 - 2012-03-14
Page 2 of 3
Investigational Drug Accountability Log: Pharmacy/Site Drug Supply Record
Name of Institution:
Product Name:
Investigator Name:
Manufacturer:
Protocol No.:
Dose Form and Strength:
Protocol Title:
Dispensing Area:
Line
No.
Date
Ex.
15Feb2012
Dispensed To
/ Received From
Manufacturer
Dose
Quantity
Dispensed and/or
Received
10 mg
+ 100 tabs
Balance Forward
/ Balance
500
600
Lot No.
Recorder’s
Initials
98765
JAD
1.
2.
3.
4.
5.
6.
7.
8.
Version 1.0: 2014 03 16
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Page 3 of 3
Page
Check if final page of log: 