What key documents are that

sponsor and investigator

should generate and retain
with regards to IP handling
and management.

Definition
IP is defined as a pharmaceutical form of an
active ingredient or placebo being tested or
used as a reference in a clinical trial, including
a product with a marketing authorization when
used or assembled (formulated or packaged) in
a way different from the approved form, or
when used for an unapproved indication, or
when used to gain further information about an
approved use.

Documents Required to generated and

retained with regards to IP handling
and management.
1) Study Responsibility/ Delegation Log
Although the Principal Investigator (PI) is
responsible for the management of the IP, the
PI could delegate the responsibility to another
person with the adequate and appropriate
qualifications and the details of drug
accountability should be recorded in the
delegation log.

2) Accountability Logs
Accountability logs serve as an inventory log
at the site to document the date of IP being
dispensed; batch or serial number, product
expiration date and subject number. The log
should be legible, accurate, recorded in real
time and any amendments should be initialed
and dated by the study staff recording the
details of the IP.

3) Shipping receipts
The original shipping receipt should be
checked against the IP shipment and filed in
the Investigator File (IF). Acknowledgement
of receipt should be sent to the sponsor as
required. Shipping receipts should be kept so
as to provide traceability of the IP batch.
4) Good Manufacturing Practice (GMP)
IP should be manufactured, handled, and
stored in accordance with applicable GMP and
should be used in accordance with the
approved protocol.

5) Certificate of Analysis Material Safety Data

Sheet
A copy of the CoA provided by the
manufacturer of IP to sponsor should be
attached together with the IP and filed in the IF
upon receipt of IP.
6) Clinical Trial Materials (CTM) license
The CTM is issued by HSA to sponsor before
the shipment of the IP, for drugs requiring
import only. A copy of CTM should be filed in
the IF.

7) IP Inventory Logs
The Principal Investigator (PI) may designate a
pharmacist to ensure the contents of the IP
inventory logs are in compliance. The designee
should maintain the IPs delivery to trial sites,
inventory at site, the use by each subject and
return to sponsor or alternative disposition of
unused IP. These records should include dates,
quantities, batch/series numbers, expiry dates
and unique code number assigned to the IP.

8) IP Accountability / Dispensing Logs

For Sponsor- and Investigator-Initiated Trials
(IIT), an IP accountability log needs to be
created bearing the protocol title and number,
name of the PI, trial site, as well as the name,
strength and dosage form of the IP.
To ensure that the IP accountability record is
accurately documented, the following
documentation must include :-

 The subject number, initials, dosage to be

administered
Amount dispensed, lot/batch number dispensed
Expiry date of the IP
Date and signature of the person dispensing the
IP
The PI/designee should maintain records that
adequately capture the dosage provided to
subjects as specified in the protocol, and the
quantity of IP dispensed must reconcile with
the amount received from the sponsor. Any
discrepancies should be recorded and notified.

9) Temperature Logs / Charts

All IPs should be stored in a temperaturecontrolled environment, within the temperature
range recommended by the protocol or
investigators brochure. A temperature log
should be used to record the temperature of the
storage environment. This is particularly
important for IPs requiring storage in the
refrigerator or freezer, where temperature
excursions may significantly compromise the
integrity of the IP.

 In the event of temperature excursions, backup plans should be in place to effect transfer
and temporary storage of the IP.

10) Equipment Maintenance Report & Device

Calibration Certificates
Refrigerators or freezers used for IP storage
should undergo maintenance checks at least
annually (or according to the sponsors or
institutions guidelines for equipment
maintenance), to ensure that the equipment is
functioning properly. A maintenance report
should be provided following the equipment
checks, and a copy of this report should be
filed in the investigator file.

11) IP Transfer / Transportation Log

Prior to any IP transfer, a log to document the
transfer of IP between different venues must
be kept in the pharmacy folder/ investigator
file of the study protocol. The IP transfer/
transportation log should include date of
transfer/transportation, quantity being
transferred, lot number, expiry date of IP and
issuing and receiving persons initials.

12) IP Destruction Form, Destruction Certificate

& IP Return Form
When the IP is to be returned to the Sponsor
for destruction, proper documentation of the
returns should be performed in the
accountability logs. If the IP is to be destroyed
at the trial site, the site may adhere to
institutional policies governing such
destruction.

 If a third party waste management company is

contracted to perform IP disposal, the site staff
should request from this company a Certificate
of Destruction following destruction of the IP.
For further details regarding toxic waste
control and pharmaceutical waste disposal
management.

SUMMARY
Investigational Product (IP) management are
to ensure the protection and safety of trial
subjects, so that they are not exposed to
unnecessary risks; ensure traceability of the IP;
ensure accurate clinical trial data that is
unaffected by inadequate safety, quality or
efficacy arising from unsatisfactory
manufacture, handling and storage of the IP
and to ensure that the IP is only dispensed to
subjects recruited for the clinical trial and it is
administered appropriately and traceable.