Responsibilities for IP management

The Principal Investigator (PI) is responsible for IP management at the investigator site.

• The PI may delegate an adequately qualified investigator site staff for IP management. The delegated investigator site staff should be under the oversight of the PI.

The sponsor may facilitate aspects of IP management for the investigator site. For example, the sponsor may:

• Provide written instructions for the investigator and/or participants for handling and storage of the IP;
• Provide template forms for IP management;
• Provide access to computerised systems for randomisation and IP management (e.g., Interactive Response Technology); or
• Arrange for the delivery of IP to the participant's location (e.g., participant's home).

Labelling requirements

IP and AP labelling requirements

The sponsor, importer and supplier must ensure that all IP and AP for clinical trials are appropriately labelled to meet the following principles:

• Ensure protection of the trial participant and product tracking
• Enable identification of the product and the clinical trial
• Facilitate proper use and storage of the product
• Ensure the reliability and robustness of data generated in the clinical trial (not applicable to supply by wholesale)

You may submit a Reasons for Labelling Omissions Form to us if you wish to omit any labelling elements.

Refer to our Guidance on Labelling of Investigational and Auxiliary Products in Clinical Trials for more details on labelling requirements of IP and AP.

Receipt of IP at the Investigator Site

Receipt of IP

IP shipping documentation / receipts and IP inventory logs should be maintained to document the receipt of IP on site.

Storage of IP at the Investigator Site

Storage of IP

Access to the IP should be secure and limited to the investigator site staff delegated to manage the IP.

The storage temperature of the IP should be monitored to provide the assurance that the IPs have been stored in accordance with sponsor or manufacturer requirements. The temperature monitoring equipment (e.g., refrigerator or freezer) and devices (e.g., data logger, min-max thermometer) should be calibrated and maintained regularly.

There should be traceability between the temperature monitoring devices, temperature logs and calibration and maintenance records (e.g., via a device ID). Temperature logs, calibration and maintenance records should be maintained on file.

Repackaging of IP at the Investigator Site

Repackaging of IP

Refer to the Guidance for IP Repackaging at the Investigator Site for details on repackaging of IP.

Dispensing of IP

Dispensing of IP

The IP should be used in accordance with the approved protocol. IP dispensing and accountability logs should be maintained.

Where applicable, the investigator or the delegated investigator site staff should explain the correct use of the IP to each participant and should check, at intervals appropriate for the trial, that each participant is following the instructions properly.

Destruction of IP

Destruction of IP

It is not necessary to obtain prior approval from us for the destruction of IP. It is the sponsor's and PI's responsibilities to ensure proper documentation are maintained for IP return and destruction.

If the IP is to be destroyed locally, it is important to comply with National Environment Agency (NEA) guidelines for disposal of drugs (particularly for cytotoxic or biohazardous items). Refer to NEA's website for more details. 

Alternative approaches for IP management

Alternative approaches for IP management for Locally Registered Products

Please refer to the Guidance on Alternative Approaches for Investigational Product Management for Clinical Trials of Locally Registered Products.

Decentralised Elements for IP management

Varied approaches for IP shipping, dispensing and/or administration

Varied approaches for shipping, dispensing and/or administration of the IP may be undertaken for the clinical trial.

For example,

• the IP may be directly shipped from the investigator site or sponsor's supplier (e.g., manufacturer, central depot, distributor) to the participant's location (e.g., participant's home); and/or
• the IP may be dispensed and/or administered at the participant's location.

The sponsor and PI should note the following before implementing varied approaches for IP management, where applicable:

• The characteristics of the IP (e.g., storage and handling requirements, blinding considerations), the route and complexity of administration, and the level of existing knowledge about the IP's safety profile should be considered. For example,
  • Cold chain management may be required during IP shipment;
  • The blinding should be maintained, if applicable;
  • It may not be practical to deliver to and administer the IP at the participant's location if the IP requires reconstitution and intravenous administration; and/or
  • Additional safety monitoring (e.g., observing the participant for adverse events) may be required post-IP administration if the safety profile of the IP is relatively unknown.
• The rationale, fitness for purpose and feasibility of the varied approaches for IP management should be described in the protocol or protocol-related document, and submitted to us.
• IP management should be arranged and conducted in accordance with applicable regulatory requirements, and safeguards should be in place to ensure product integrity, product use per protocol and participant safety.
• The sponsor and PI should maintain adequate oversight of the varied approaches for IP management.
• Agreements should be established with service providers (e.g., couriers, home nurses). In situations where the investigator is supported by the sponsor in identification of a suitable service provider, the investigator retains the final decision on whether the service provider intended to support the investigator is appropriate based on information provided by the sponsor. In such a situation, the investigator should ensure that the clinical trial agreement made with the sponsor specifies the involvement of the service provider.
• The PI should delegate the investigator site staff or service providers (e.g., home nurses), and ensure they are adequately qualified to perform their delegated tasks.
• Participants should be informed about the varied approaches for IP management, and consent to their use.
• Additional safeguards are implemented to protect the privacy of the participant and the confidentiality of the participant's data and disease status. For example, the personal data of the participant (e.g., name and contact details) should not be divulged to the sponsor, and the disease status of the participant should not be divulged to the courier.
• The IP should be delivered to the intended recipient.
• Written instructions should be provided to the investigator sites for handling and storage of the IP.
• Written instructions should be provided to the participants for receipt, use and return of the IP.
• The traceability of the IP should be maintained throughout the IP supply chain.
• The treatment blinding should not be compromised.
• IP documentation should be maintained and reviewed.

Documentation for AP management

Documentation for AP management

Documentation for receipt, storage, repackaging, dispensing and accountability, return and destruction for AP should be maintained on file, unless it is managed in accordance with clinical practice.