Monitoring drug packaging in clinical trial process

• US 8,165,892 B2
• Filed: 06/21/2002
• Issued: 04/24/2012
• Est. Priority Date: 06/23/2001
• Status: Active Grant

• Current Assignee: Smithkline Beecham PLC (GSK plc)
• Original Assignee: Smithkline Beecham PLC (GSK plc)
• Inventors: Day, Stephen, Carter, Paul Laurence, Evans, Peter Graham, George, Lesley Julia
• Primary Examiner(s): RANGREJ, SHEETAL
• Application Number:
  US10/481,219
• Publication Number:
  US 20040243620A1
• Time in Patent Office: 3,595 Days
• Field of Search: 705 2- 3
• US Class Current: 705/2
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

A method for automatically tracking compliance in a clinical trials process involving one or more operations comprising selecting a container; associating an identifier with the container, the identifier having a unique signature data item thereon; reading the unique signature data item to a relational database; performing a first operation relating to the container; checking the performance of the first operation against a compliance standard; following the successful completion of the first operation, writing an associated compliance data item to the relational database; optionally performing one or more further operations relating to the container; and following the successful completion of each optional further operation or a package thereof, writing an associated compliance data item to the database.

Claims

1. A method for automatically tracking compliance in a clinical trials process involving the operations of preparing a label comprising textual information, applying the label to the container, and performing one or more following operation relating to the container comprising:

providing a container having associated therewith an identifier comprising a radio frequency identifier comprising an antenna for transmitting or receiving radiofrequency energy, and an integrated circuit chip connecting with said antenna, said chip comprising a memory having a unique signature item written thereon;

providing an apparatus comprising;

means for selecting said container by reading the unique signature data item on the memory, means for writing said unique signature data item to a relational database, means for preparing a label comprising textual information and applying the label to the container;

means for checking that the correct label has been applied against a compliance standard and, following the successful completion of applying the label to the container, for writing an associated compliance data item to said relational database and to the memory of the identifier;

selecting the container by reading the unique signature data item on the memory;

associating the identifier with said container;

reading said unique signature data item to the relational database;

performing the operation of applying the label to the container;

checking the that the correct label has been applied to the container against a compliance standard;

following the successful application of the label to the container, writing an associated compliance data item to said relational database and to the memory of the identifier;

wherein the compliance data item includes an acknowledgement that the correct label has been applied to the container;

then further comprising performing one or more following operation selected from list consisting of;

introducing the correct type and quantity of a drug substance for trial, placebo or comparison drug substance into the container;

applying or removing a closure to or from the container;

storing the container in a predetermined location and subsequently removing the container therefrom;

storing the container under suitable environmental conditions;

selecting the container and enclosing it in a secondary pack;

dispatching the container to or receiving the container from a predetermined address;

transmitting information relating to the container to a predetermined recipient and, receiving information relating to the container from a predetermined recipient;

checking the performance of each following operation against a compliance standard;

and following the successful completion of each said following operation, writing an associated compliance data item to the database and to the memory of the identifier.

2. A method according to claim 1 wherein the following operation comprises the selection of a container and introducing the correct type, and quantity of a drug substance for trial, placebo or comparison drug substance into the container;

the associated compliance standard being checking that the correct type, and/or quantity of a drug substance for trial, placebo or comparison drug substance has been introduced into the container.

3. A method according to claim 1 wherein the following operation comprises applying or removing a closure to or from a container;

the associated compliance standard being checking whether or not the cap is in place.

4. A method according to claim 1 wherein the following operation comprises storing a container in a predetermined location and subsequently removing the container therefrom;

the associated compliance standard being confirming that the correct container is at the correct location.

5. A method according to claim 1 wherein the first or further operation comprises storing a container or substance under suitable environmental conditions;

the associated compliance standard being to ensure that suitable environmental conditions have been followed.

6. A method according to claim 1 wherein the following operation comprises selecting a container and enclosing it in a secondary pack;

the associated compliance standard being checking that the correct container has been enclosed within the correct secondary pack.

7. A method according to claim 1 wherein the following operation comprises dispatching to or receiving a container at a predetermined address;

the associated compliance standard being checking that the address is correct and/or that the correct container has arrived at the correct address.

8. A method according to claim 1 wherein the following operation comprises

transmitting to a predetermined recipient, and receiving information relating to the container by a predetermined recipient;

the associated compliance standard being ensuring that the correct information is sent to and received by the correct recipient.

9. A method according to claim 1 wherein the unique signature data item comprises a unique machine readable number or code.

10. A method according to claim 1 wherein the method comprises reading the associated compliance data item and acknowledging confirmation of the reading prior to performing further operations relating to the container.

11. A method according to claim 1 wherein the method additionally comprises reading at least one compliance data item in the identifier memory prior to performing any following operation relating to the container.

12. A method according to claim 1 involving checking at least one compliance data item stored on the memory of the identifier or on the relational database against a defined criterion stored on the relational database.

13. A method according to claim 1 comprising a final reading step involving reading all compliance data items on the relational database and/or the identifier memory subsequent to the completion of the clinical trial operations.

14. A method according to claim 1 wherein the compliance data item comprises an operation or list of operations which must be carried out for full compliance to be registered and the subsequent checking involves ticking off the compliance data item, by writing to the database or identifier memory, associated with any operation once it has been completed.

15. A method according to claim 1 wherein a positive compliance data item for each operation is written to the database following the completion thereof.

16. A method according to claim 1 wherein the label comprises textual information and also an identifier comprising a unique signature data item, and confirming that the correct label is attached to the container is done by reading the unique signature data items attached to both the container and the label.

17. A method according to claim 1, wherein the identity of the container is determined by the unique signature data item encoded on a tag thereon, and the identity of the container and of a substance with which it is filled is stored in the relational database together with associated labelling data, a label is then generated and applied to the container, the label reproducing labelling data associated in the database with the identified container, the label is then read, and as a compliance check the read matter is checked against the identity of the container to validate that the correct label has been applied.