Clinical Trial Documents

8/10/2019 Clinical Trial Documents

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What key documents are thatsponsor and investigator

should generate and retain

with regards to IP handling

and management.


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Definition

IP is defined as a pharmaceutical form of an

active ingredient orplacebo 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, orwhen used to gain further information about an

approved use.


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Documents Required to generated and

retained with regards to IP handling

and management.

1) Study Responsibility/ Delegation Log

Although the Principal Investigator (PI) isresponsible 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.


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2) Accountability Logs

Accountability logs serve as an inventory logat 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.


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3) Shipping receipts

The original shipping receipt should be

checked against the IP shipment and filed inthe Investigator File (IF). Acknowledgement

of receipt should be sent to the sponsor as

required. Shipping receipts should be kept soas to provide traceability of the IP batch.

4) Good Manufacturing Practice (GMP)

IP should be manufactured, handled, andstored in accordance with applicable GMP and

should be used in accordance with the

approved protocol.


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5) Certificate of AnalysisMaterial 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 requiringimport only. A copy of CTM should be filed in

the IF.


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7) IP Inventory Logs

The Principal Investigator (PI) may designate a

pharmacist to ensure the contents of the IPinventory 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.


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8) IP Accountability / Dispensing Logs

For Sponsor- and Investigator-Initiated Trials

(IIT), an IP accountability log needs to be

created bearing theprotocol 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 :-


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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

IPThe 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.


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9) Temperature Logs / Charts

All IPs should be stored in a temperature-

controlled environment, within the temperature

range recommended by the protocol or

investigators brochure. A temperature log

should be used to record the temperature of thestorage environment. This is particularly

important for IPs requiring storage in the

refrigerator or freezer, where temperatureexcursions may significantly compromise the

integrity of the IP.


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In the event of temperature excursions,back-

up plansshould be in place to effect transfer

and temporary storage of the IP.


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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 equipmentmaintenance), to ensure that the equipment is

functioning properly. A maintenance report

should be provided following the equipmentchecks, and a copy of this report should be

filed in the investigator file.


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11) IP Transfer / Transportation Log

Prior to any IP transfer, a log to document the

transfer of IP between different venues mustbe kept in the pharmacy folder/ investigator

file of the study protocol. The IP transfer/

transportation log should include date oftransfer/transportation, quantity being

transferred, lot number, expiry date of IP and

issuing and receiving persons initials.


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12) IP Destruction Form, Destruction Certificate

& IP Return FormWhen 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.


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If a third party waste management company is

contracted to perform IP disposal, the site staffshould 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.


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SUMMARY

Investigational Product (IP) management are

to ensure the protection and safety of trialsubjects, so that they are not exposed to

unnecessary risks; ensure traceability of the IP;

ensure accurate clinical trial data that isunaffected 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.

Clinical Trial Documents

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