Documentation and Labelling

Shipping and storage of trial related materials

CNS can arrange the importation of clinical trial materials (trial medication, laboratory agents, sample material etc.) and delivery either directly to the research site, or to a third party storage and dispensing facility. Local temperatures can exceed 36 °C during summer months and safe storage of materials is very important.

The logistics of delivering trial materials to Queensland are easily managed due to Brisbane’s status as a major shipping port.

Drug or device labelling requirements

There are more requirements for the labelling of drugs and medical devices used in clinical trials than there are for standard labelling of registered therapeutics. Because the majority of clinical trials are blind or double blind studies, there is a great need to ensure that contents of clinical trials packs are easily and rapidly identifiable in the event of a serious safety issue. Traceable information is required to appear on the inner and outer packaging.

Key information that must be included on the packaging includes:

• name of sponsor – this must be the Australian sponsor as listed on the CTN;
• dosage form, route of administration, quantity of dosage units. In the case of an open trials a name/identifier of the product and strength/potency must also appear;
• trial reference or protocol number;
• batch and/or code number to identify the contents and packaging operation;
• trial subject identification number, where applicable;
• directions for use;
• 'For clinical trial use only' in red print;
• name of the investigator (if not included as a code in the trial reference code);
• a trial reference code allowing identification of the trial site and investigator;
• storage conditions;
• period of use (use by, expiry or retest date as applicable in month/year format); and
• 'Keep out of reach of children' in red print, except when the product is for use only within a hospital.

The outer packaging may include symbols or pictograms that clarify required information and a statement to ‘Return empty packaging and unused products’. Additional information, such as warnings and handling instructions, may also be displayed. A copy of each type of label needs to be kept in the batch record.

More detailed information regarding ADR and ADE classifications, reporting and other reporting requirements can be found in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia – October 2004.