In the past, clinical trial sites have been unaware of the regulations governing packaging and shipment of biological specimens [49 CFR 172.702]. Recently, the FAA has audited and fined clinical trial sites for failure to properly train and certify site personnel regarding packaging and shipping biological specimens in conjunction with clinical trials. Many industry clinical trial sponsors will soon be (if they are not already) requesting evidence of certification of relevant clinical research personnel when biological specimen shipment is required as a part of the research study.
Employees who pack and ship biological specimens (considered infectious substances) must be trained and certified in their handling, packaging, and transportation. Examples of those requiring certification are:
- Clinical research coordinators
- Research nurses
- Research assistants
- Data managers shipping clinical specimens
It is the employer's responsibility to assure training and certification. This process must be repeated within 24 months of the previous training.
Training and certification courses can be obtained in a number of ways. Courses are offered around the country through the Department of Transportation (DOT) and by other organizations listed on the DOT website at http://hazmat.dot.gov/training/training.htm
Federal Express also offers training and certification courses at http://www.fedex.com/us/services/options/hazmat/training.html