Understand the requirements on handling investigational and auxiliary products in a clinical trial.
An investigational product (IP) is defined as a therapeutic product, Class 2 cell, tissue and gene therapy product (CTGTP), 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, Class 2 CTGTP 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 our Guidance on Labelling of Investigational and Auxiliary Products in Clinical Trials484 KB for examples of investigational products and auxiliary products.
The sponsor, importer and supplier must ensure that all IP and AP for clinical trials are appropriately labelled to meet the following principles:
You may submit this form36 KB to us if you wish to omit any labelling elements.
Refer to our Guidance on Labelling of Investigational and Auxiliary Products in Clinical Trials484 KB for more details on labelling requirements of IP and AP.
Shipping records and inventory logs should be maintained on file to document the receipt of IP and AP on site.
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.
Refer to the Guidance for IP Repackaging on Site208 KB for details on repackaging of IP.
The IP should be used in accordance with the protocol. IP dispensing and accountability logs should be maintained on file.
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.
Please refer to the Guidance on Alternative Measures for Investigational Product Management for Clinical Trials of Locally Registered Products222 KB whereby the hospital pharmacy is utilised to manage the IP.
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.
Refer to our page on regulatory guidances for more information on managing IP and AP.
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