Clinical Trial Toolkit for Clinical Researchers
Summary Sheet
Title:
Purpose:
Details:
Investigational Product Accountability Log: Subject Record
To document all study product disposition and accountability on the subject level.
This tracking log should provide a comprehensive list of all study product
disposition on the subject level. It is required for interventional clinical studies
using a study product for research.
The column headings indicated on the below log are only suggestions and may
be modified to meet study needs.
Rules &
Regulations
Best Practice
Recommendations:
Version 1.0 - 2012-03-14
HC Guide - 0068 items 8.2.23 quires 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 “Subject Record” may be used to record dispensing and return of
study product on the subject level. The associated “Pharmacy/Site Drug
Supply Record” is a separate log that may be used by the pharmacy or
site to record overall bulk study product supplies and accountability.

In the “Quantity Dispensed and/or Received” column, use a ‘+’ before
the number when receiving product, use a ‘-’ before the number when
dispensing product. See the example provided within the below log.

In the “Balance Forward” column, use the diagonal line across the box to
record the previous balance forward / the resulting balance, e.g., 600 /
500. See the example provided within the log.

The record keeper should initial the line item as the information is
entered. Ensure all record keepers information is recorder on the task
distribution list or on a site delegation log.

Create additional lines and pages as needed.

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
pharmacy) so blinding can be maintained.

Number each 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 use of the log.
Log Revision History:
Version
Number
Date
Summary of Revisions Made:
1.0
05Feb2010
First approved version
2.0
29Jul2011
Revised Investigational Agent to Investigational Product
Accountability Log: Subject Record
3.0
04Jan2012
Added Summary Sheet; removed form’s automatic page
numbering
4.0
14Mar2012
Revised Summary Sheet; revised for use as a Subject Record
log; added check box to footer
References:
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 @
http://www.nidcr.nih.gov/Research/toolkit/
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/docs/gui_68-eng.php
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
Additional supporting Material:
N2 Network of Networks SOP 010_05
Version 1.0 – 2014 03 06
2/3
Investigational Product Accountability Log: Subject Record
Name of Institution:
Product Name:
Investigator Name:
Manufacturer:
Protocol No.:
Dose Form and Strength:
Protocol Title:
Dispensing Area:
Line
No.
Date
Subject ID
Number
Subject’s
Initials
Dose
Quantity
Dispensed
and/or Received
Ex.
15Feb2012
12345
ABC
10 mg
- 100 tabs
Balance
Forward
/ Balance
600
500
Lot No.
Recorder’s
Initials
98765
JAD
1.
2.
3.
4.
5.
6.
7.
Version 1.0 2014 03 06
Page __
Check if final page of log: 