Drug Evaluation Committee 2013-30 Scope of the Investigational New Drugs Control Chart

Related classification: Other

First published: Sep. 2013
Revised publication date: December 2021

Question

Article 39 Guidance 4 of the GCP stipulates that the head of the site or investigational drug manager shall prepare and maintain records of the following items.

I think it is sufficient to exchange the delivery note and receipt for the investigational drug when a) is delivered, and c) and d) are recorded by filling in the investigational drug management chart.

My question is, with regard to "b) Inventory at the site," is it sufficient to note all of the investigational drug use receipt forms and the investigational drug use control chart? Or should we make sure to prepare something like a cash register that is separate from these so that we can see the inventory at that time in real time?

The second sentence of Article 39 Guidance 4 of the GCP states, "These records shall include the date, quantity, serial number or manufacturing code, expiration date (if necessary), and investigational drug and subject identification codes. Is it correct to interpret this as referring to the delivery note/receipt of investigational drug for use and the control chart of investigational drug for use? Or, if a cash register is required by the previous question, do these items have to be included in the cash register as well? If the cash register is to be prepared, is it not sufficient to know the difference of the quantity of drugs used in a clinical trial?

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

The record of "Inventory at the site" should be properly managed by the investigational drug manager in accordance with the procedure manual for the management of investigational drugs provided by the sponsor, and should include the "receipt of investigational drugs delivered to the site," "usage status by subject," and "return or alternative disposition of unused investigational drugs to the sponsor," as stated in Article 39, Guidance 4. If the inventory at the site can be ascertained from the "receipt of investigational drugs delivered to the site," "usage status by subject," and "return or alternative disposition of unused investigational drugs to the sponsor" in Article 39 Guidance 4, then there is no need to create another record such as a cash register.

In addition, the "date, quantity, serial number or manufacturing code, expiration date, investigational new drug, and subject identification code" should be entered on the delivery/receipt of investigational new drug and the control chart for investigational new drug in accordance with the purpose of creating such records. It is not necessary to fill in all of the above items on each of the delivery form of investigational new drug, control chart of investigational new drug, and return and collection form of investigational new drug.

Supplement

Please refer to Opinion 2020-48 for the investigational drugs other than investigational drugs that are not delivered by the sponsor and are used from the inventory kept by the site.

Reason for revision of opinion

Supplementation has been added in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).

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