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Drug Supply Management and Accountability

The record keeping associated with the receipt, storage, and dispensation of an investigational product is known as study drug accountability. While the study sponsor is responsible with packaging and distributing the product to the study sites, it is the responsibility of the site to maintain adequate records of the products handling and dispensation.

Often sponsors will provide tools such as tracking logs to assist in the maintenance of such records. However, if no tools are offered by the sponsor, the site should plan to develop their own tracking method. For all hospital-based drug studies, Investigational Drug Services is responsible for managing the research study drug supply and drug accountability records.

Packaging

Study drug will often be packaged to protect the product, ease dispensation, and to preserve blinding when necessary. Typically the packaging will offer a place to record the study participant ID.

Receipt

When study drug is received at the study site, it is important to inspect the shipment in its entirety. The packing slip should be compared to both the order form and the contents of the shipment. Often study sponsors will require that the packing slip be signed, dated, and returned in order to acknowledge receipt of the shipment. If it appears that the shipment is incomplete or was damaged in transit, contact the sponsor immediately.

Storage

Storage instructions should be included with the shipment, including specifications for temperature ranges. Study drug should always be stored in a secure location, either at the study pharmacy or in a locked cabinet within a separately locked room. Temperature logs should be maintained in the storage area to ensure that the product remains viable.

If study drug requires storage in a refrigerator, the refrigerator should have a lock on it and should remain free of food. This means that study drug cannot be kept in the break room refrigerator. Likewise, lunch cannot be kept in the study drug refrigerator.

Dispensation

The tracking of study drug dispensation can become complicated with many study participants over the course of a lengthy trial. Meticulous records are required in order to be compliant with accountability. Study drug received from the sponsor should be tracked, as well as drug dispensed to study participants. So there is a constant flow of drug in and drug out.

Example 1:

Study drug received is tracked on the same log as study drug dispensed.

Received/
Dispensed

Date

Participant ID

Lot #

Quantity

Total Remaining

Received

06/01/2010

NA

L0124

12 bottles

12 bottles

Dispensed

06/03/2010

101

L0124

2 bottles

10 bottles

Dispensed

06/04/2010

102

L0124

1 bottle

9 bottles

Dispensed

06/06/2010

103

L0124

2 bottles

7 bottles

Received

06/07/2010

NA

L0216

12 bottles

19 bottles

Dispensed

06/10/2010

101

L0124

1 bottle

18 bottles

Example 2:

Study drug received is tracked on one log and study drug dispensed is tracked on a separate log.

Received/
Dispensed

Date

Participant ID

Lot #

Quantity

Total

Received

06/01/2010

NA

L0124

12 bottles

12 bottles

Received

06/07/2010

NA

L0216

12 bottles

24bottles

 

Received/
Dispensed

Date

Participant ID

Lot #

Quantity

Total

Dispensed

06/03/2010

101

L0124

2 bottles

2 bottles

Dispensed

06/04/2010

102

L0124

1 bottle

3 bottles

Dispensed

06/06/2010

103

L0124

2 bottles

5 bottles

Dispensed

06/10/2010

101

L0124

1 bottle

6 bottles

Example 3:

Study drug received is tracked on one log and study drug dispensed is tracked on a separate log per subject.

Received/
Dispensed

Date

Participant ID

Lot #

Quantity

Total

Received

06/01/2010

NA

L0124

12 bottles

12 bottles

Received

06/07/2010

NA

L0216

12 bottles

24 bottles

 

Received/
Dispensed

Date

Participant ID

Lot #

Quantity

Total

Dispensed

06/03/2010

101

L0124

2 bottles

2 bottles

Dispensed

06/10/2010

101

L0124

1 bottle

3 bottles

Unblinding

In rare cases, the unblinding of study drug is required. This may occur as a result of an adverse event where it is necessary to know the type of study treatment that was being received in order to determine how to treat the event. Unblinding procedures vary from study to study and should be covered during protocol training, such as the Site Initiation Visit or Investigator Meeting.

Disposition

The sponsor will determine if remaining study drug will be returned or destroyed on site at study completion. Thus drug reconciliation often occurs as part of the Close-Out Visit. It is important to keep all empty containers until a reconciliation has occurred and permission was granted by the sponsor to return or destroy drug. This includes keeping any empty pill bottles, vials, etc. Study participants should always be informed that they should return their empty containers rather than discarding them. Adequate records should be maintained whether study drug is returned or destroyed on site. Any discrepancies should be clearly noted in a memo-to-file.

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