Conducting clinical trials

  1. ​Investigational and auxiliary products

​Investigational and auxiliary products

Understand the requirements on handling investigational and auxiliary products in a clinical trial. 

What are investigational products and auxiliary products

An investigational product (IP) is defined as a therapeutic product, medicinal product or a placebo that is to be tested or used as a reference in a clinical trial.

An auxiliary product (AP) is therapeutic product or medicinal product used for the needs of a clinical trial as described in the protocol, but not as an IP. 

Please refer to Table 1 of the Guidance on Labelling of Therapeutic Products and Medicinal Products Used in Clinical Trials572 KB for examples of investigational products and auxiliary products.

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 subject and traceability
  • 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 this form25 KB to us if you wish to omit any labelling elements.

Refer to our Guidance on Labelling of Therapeutic Products and Medicinal Products Used in Clinical Trials572 KB for more details on labelling requirements of IP and AP. 

Receipt of IP

Receipt of IP

Shipping records and inventory logs should be maintained on file to document the receipt of IP and AP on site.

Storage of IP

Storage of IP

Access to the IP should be limited and secure.

The storage temperature of the IP should be monitored to provide the assurance that they have been stored in accordance with sponsor or manufacturer requirements. The temperature monitoring devices should be calibrated and maintained regularly.

There should be traceability between the temperature monitoring devices, temperature logs and calibration and maintenance records. Temperature logs, calibration and maintenance records should be maintained on file. 

Repackaging of IP

Repackaging of IP

Refer to the Guidance for IP Repackaging on Site398 KB for details on repackaging of IP. 

Dispensing of IP

Dispensing of IP

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

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 receipt, storage, dispensing, accountability, return and destruction.

If the IP are 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 measures for IP management

Alternative measures for IP management

Please refer to the Guidance on Alternative Measures for Investigational Product Management for Clinical Trials278 KB of locally registered therapeutic products or medicinal products whereby the hospital pharmacy is utilised to manage the IP.

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.

Regulatory guidances

Refer to our page on regulatory guidances for more information on managing IP and AP. 

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