SOP for Handling and Shipping of Biological Substances and Dangerous Goods

Purpose

To outline the procedures to follow when handling and shipping Biological Substances and/or Dangerous Goods in clinical trials to ensure the safety of all staff when carrying out this activity. To also outline the regulations that govern this activity in clinical trials.

Scope

This SOP applies to all relevant employees including, but not limited to, visiting health professionals, contractors, consultants and volunteers who propose to undertake, administrate, review and/or govern human research involving patients/participants, facilities and or staff. All study personnel involved in the clinical study must operate within their scope of practice.

This SOP covers the handling and shipment of biological substances category B and dangerous goods (dry ice) only. When references to biological samples/specimen/substances are made, category B is implied.

Procedure

Handling and Shipping of Biological Substance and Dry Ice in Clinical Trials

This activity may be delegated to another staff member or third-party service provider, provided they hold a current certificate to do so. This duty is delegated as per SOP for Site Staff Qualifications, Training Records and Capability. It is still the Investigator’s responsibility to ensure all procedures and regulations are adhered to.

The Investigator must:

• Ensure all study staff, who have cause to handle or ship biological substances, hold a current certificate in the International Air Transport Association (IATA) Approved, Civil Aviation Safety Authority (CASA) Certified Dangerous Goods Packaging Course.
• Ensure specimens are collected and handled in accordance with local and Sponsor requirements as written in the Protocol and laboratory manual.
• Ensure specimens are packed and shipped in accordance with local and Sponsor requirements as written in the Protocol and laboratory manual and according to IATA requirements, including that a valid export permit is in place, if required.
• Ensure that in situations where research personnel do NOT hold current certification, arrangements for biological substance/dry ice shipment are made with IATA certified Pathology Laboratory staff or external third party.
• Ensure that the National Pathology Accreditation Advisory Council (NPAAC): Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials are followed by relevant certified staff.
• Ensure any training is recorded on the Training Log as per SOP for Site Staff Qualifications, Training Records and Capability and copies of certificates are kept in the respective site file (SMF/SSSF).
• Ensure that documentation (e.g. receipts, shipping records, order forms, proformas) related to handling and shipment of biological specimens is maintained and filed in the respective site file (SMF/SSSF). Sites frequently take biological samples (e.g. tissue, blood, urine, and sputum) from trial participants that are then processed, stored, packed and transported to local or central laboratories. To ensure that the integrity of biological samples has been maintained, there should be evidence of the chain of custody from their point of collection through processing, storage, transport, through to disposal, with evidence of appropriate storage and transit conditions.

Notes regarding Certification to handle and transport biological substances and Dry Ice

• To organise training for handling and shipping of biological substances and dry ice, staff should contact their Pathology Service/Laboratory. The CASA Certified Dangerous Goods Packaging Course can be done by any media and must be recorded on the respective Training Log as per SOP for Site Staff Qualifications, Training Records and Capability.
• CASA Regulations have defined categories of personnel who should attend training and the subject matter in which they must be qualified. These regulations are mandatory and legally binding and consequently must be adhered to in full.
• Re-certification is required every two years. Certificates and any training records must be kept for a minimum period of 36 months from the most recent training completion date, and must be made available, upon request to the Sponsor, regulatory authority, and CASA.

Annexure

Nil

Revision History

Nil

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