Here are a few examples of what you can find inside: contact numbers, protocol and project number, the visit test schedule, specimen collection instructions, example requisitions, result reference ranges and much more!
Some studies, but not all, will have automatic resupply. In order to trigger this service for expired or damaged kits, sites need to notify Covance when this occurs. It is important to keep your kit inventory updated in order to have automatic resupply orders trigger properly. You can notify us about your kit inventory, or order any needed kits if your study does not have automatic resupply, via the kit order website: http://www.covance.com/kitordering.
Please fill out the required fields and write the kit name and inventory number under the comments section.
To ensure the validity of the tubes contained in the collection kit, expiration dates are printed on the outside of the kit box. The expiration date of each kit corresponds to the shortest expiration date of the tube(s) within the kit.
Please do not collect specimens in expired containers! Specimens received in an expired container which includes an additive will be canceled as: “Sample drawn in expired tube: Testing not performed.”
If you have expired tubes please use the online web tool at http://www.covance.com/kitordering to have these kits replaced and your inventory updated.
Covance’s Investigator Training Center is a global group of professional speakers who conduct face-to-face meetings or remote trainings to help sites master and comprehend all the details in the Laboratory Manual.
Think of them like your very own tutor – helping you maneuver the ins and outs of a study. They can provide eLearnings or even go to a site to train staff directly.
“We make sure everyone is on the same page for the study,” said Sr. Investigator Trainer, Dalia. “It’s important that everyone knows how to collect a sample in the same way. It makes for more reliable data.”
And considering that lab results are the biggest part of a sponsor’s FDA submission, it is critical to the integrity of the study that the data is consistent.
“Even if you have worked with Covance before or have been doing trials for years; it’s a small investment upfront for success down the road,” said Dalia.
If a site is interested in scheduling training, contact the sponsor. Remember, the training can be customized by type of training, length and location. It can be done in person, over the phone, via a WebEx or done by sharing archived eLearnings. If it is done in person, the trainers will bring demo supplies: kits, bulk supplies and may even include shipping supplies. This ensures sites will know what to expect during a study. It also allows monitors and the study team to familiarize themselves with what the sites will encounter.
Dalia said, “We are often the face of Covance to a site and want to make sure sites are prepared and ready to run a successful, efficient clinical trial.”
This post originally appeared in 2015 and has been modified. It is the first in a series that will be released to highlight investigator training, our training staff, and the eLearning course.
Love working with Covance? Have suggestions for improvements? Share your thoughts on the upcoming Investigator Site Survey coming later this year. This short survey will ask you to provide feedback on a variety of services from kit production to Investigator Training to Site Communications.
The surveys are anonymous and provide you with a quick way to tell us what we are doing well or where we might need to improve. Your comments are important. In fact, changes to the new lab manual, are a direct result of feedback we got from the 2015 site survey.
The survey is short and should take less than five minutes to complete. Keep an eye out for the survey coming in the coming months. It will be emailed to all Investigator Sites.
You may not be aware that needles and/or Diff-Safe® devices either used or not, should never be returned to Covance. They pose a very real safety risk not only for Covance staff but to courier staff as well. Please ensure that your staff is aware of this and remind them of the dangers of returning sharps to Covance.
Needles (whether covered or not) and Diff-Safe® devices should always be disposed of at your site in an approved Biohazard Infectious Waste Sharps Container.
In addition to the safety risk, data can be lost if the tubes are shipped with the
Diff-Safe® device still inserted in the tube. If the sample is shipped with the Diff-Safe® device still intact, blood may spill into the specimen collection bag during transit, rendering the sample useless for analysis. For your convenience, Diff-Safe® device safety tips are included here:
1) What is dry ice?
Dry ice is solid Carbon Dioxide (CO2) with a low temperature of -78° C (-109° F). At atmospheric pressure, solid CO2 sublimates or changes directly to CO2 gas without a liquid phase.
2) How long are samples kept in dry ice? And does the long-term storage affect any sample analysis?
Samples can be kept frozen in dry ice for days, depending on the analytes/biomarker frozen stability. As dry ice has a limited shelf-life, long term storage of specimens can be jeopardized in case of insufficient replenishment of dry ice. For long term storage of specimens we recommend using a standard medical/scientific freezer instead of dry ice, with appropriate freezer’s temperature monitoring. Continue reading
This article originally appeared in early 2016.
Hemolysis is defined as the alteration, dissolution or destruction of red blood cell membranes in such a manner that hemoglobin is freed into the medium in which the cells are suspended. Hemolysis can be caused by antibodies, toxins, chemicals or physical stress from dilution, extremes of pressure, or shear forces or temperature during phlebotomy or preparation of serum. Even time can cause hemolysis, through the exhaustion of available glucose, which is necessary to maintain the fluidity and stability of the cell membranes. Continue reading
This article originally appeared in late 2014. However, the information is still relevant and may help sites when faced with the need to substitute a kit, especially given the recent K2 EDTA tube recall. Please see this notice which was shared with impacted sites.
Substituting kits is a lot like substituting ingredients in a recipe: you have to find the item that is closest to what you are missing. Of course, It’s best to not have to substitute one kit for another, or with our example above, one ingredient for another, but sometimes a situation develops where you have no choice and have to find the best match.
To avoid that last minute scramble, it is important to monitor all site supplies and expiration dates. This should be done routinely and well in advance of any patient visits. Kits can be ordered on our resupply website at:www.covance.com/kitordering. It’s important to be aware of the number of days required for resupply as it varies by region. This information is also available on the website. Continue reading