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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
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