clinical research and GCP III ….Case Study: IMP Management

Below you will find the section from ICH GCP regarding the investigator’s responsibility for Investigational Medicinal Products.

In today’s case study we are looking at site management of IMP, so the results of a monitor’s review of the drug accountability and storage records are below the ICH GCP section.  What action(s) should be taken? 

ICH GCP Section 4.6 Investigational Product(s)

4.6.1  Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.

4.6.2  Where allowed/required, the investigator/institution may/should assign some or all of the investigator’s/institution’s duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution..

4.6.3  The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution, should maintain records of the product’s delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial subjects. Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.

4.6.4  The investigational product(s) should be stored as specified by the sponsor (see 5.13.2 and 5.14.3) and in accordance with applicable regulatory requirement(s).

4.6.5  The investigator should ensure that the investigational product(s) are used only in accordance with the approved protocol.

4.6.6  The investigator, or a person designated by the investigator/institution, should explain the correct use of the investigational product(s) to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly.

Monitoring report IMP Management narrative section 

It appears that two subjects with the same initials were seen on the same day and they have been dispensed each other’s medication.

IMP temperature excursion occurred, pharmacist says it was identified within a couple of hours and was only a few degrees out of range so they have taken no action.

Drug accountability log is incomplete as two subjects have returned medication and this has not yet been reconciled.

Monitor’s actions – which of the following actions should the monitor take straight away?

Ask investigator to withdraw the subjects who received the wrong medication

•  Yes
•  No

Check whether temperature excursion is within tolerance limits

•  Yes
•  No

Ask Pharmacist to quarantine IMP exposed to temperature excursion

•  Yes
•  No

Ask Investigator to withdraw any subjects who have been dispensed IMP exposed to temperature excursion

•  Yes
•  No

Complete the drug accountability log herself

•  Yes
•  No

Report the pharmacist to the relevant professional body

• Yes
• No