Quality Issues

 

Research-Grade Vectors

For problems or questions regarding the quality of research materials please contact:

Dr. Jeffrey Beecham - 919.962.1245, jbeecham@email.unc.edu

Lab Manger Xing-hua Zeng - 919.962.1221, xhzeng@med.unc.edu

JVL staff will investigate the problem and if it originated in the Vector Labs, then the product will be replaced free of charge.   Please retain any unused aliquots of the vector(s) so they can be tested by the core to determine the source of the problem.

Quality problems that will be addressed by the core for research-grade materials are limited to problems arising from the production of the vector itself.  Problems arising from unexpected effects of transgene expression, vector toxicity, vector administration or experimental design cannot be addressed.

 

Pre-Clinical-Grade Vectors

For quality problems or questions regarding pre-clinical vectors please contact:

Dr. Jeffrey Beecham - 919.962.1245, jbeecham@email.unc.edu

Quality Assurance Officer Lori Nisi - 919.962.1244, nisi@email.unc.edu

JVL staff will investigate the problem and if it originated in the Vector Labs, then the product will be replaced free of charge.   Please retain any unused aliquots of the vector(s) so they can be tested by the core to determine the source of the problem.

Investigators should notify the JVL of any problems that may be due to the vector.  This includes:

Vector Quality

Unexpected effects of transgene expression

Vector toxicity

Mortality or morbidity following vector administration

 

Clinical-Grade Vectors

For quality problems or questions regarding clinical vectors please contact:

Dr. Jeffrey Beecham - 919.962.1245, jbeecham@email.unc.edu

Quality Assurance Officer Lori Nisi - 919.962.1244, nisi@email.unc.edu

The investigator must notify the JVL as soon as possible of any problems encountered with the use of clinical vectors.  Federal Law requires that the investigator or study sponsor notify the FDA, and the NIH OHRP of any adverse events associated with the use of clinical products within specified time limits.  Other State and Local regulations may include additional reporting requirements.