Thank you to all who have visited our blog over the past several years! As of 01-April-2019, we will be transitioning away from utilizing this platform. Many of the training resources found here are now available on the Covance Investigator Study Team web page. Additionally, we are hard at work developing new ways to share information with you. Be on the lookout for our newsletter that will launch later this year with useful information and training videos geared specifically toward investigator study teams! Until then, you will continue to receive information notices and training material through email, our web portal, and/or fax as applicable for your study. Thank you again for your support of the inSITE blog!
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.
Reference ranges are important criteria to evaluating your patient’s laboratory results. Covance provides reference ranges that are age and gender specific and represent a heterogeneous clinical trials patient population. Covance uses a series of flags to represent the meaning of a patient’s test results which fall outside of the reference range.
If a patient’s value triggers a flag, it will print on the laboratory report. Your sponsor may request additional flags. These will also print on the laboratory report.
In order to ensure timely assessment of patient care, regulations require immediate reporting of laboratory values with potentially critical implications for the patient. For all HP and LP flags, Covance calls the investigator site and requires a live voice to receive these values and read back. Notification of other flags are determined by the sponsor of the protocol.
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:
After placing your online kit order through our website, please make sure you receive an order confirmation email; this means that your order has been successfully submitted.
Additionally, regularly check your inbox for potential queries from our Kit Inventory Department who will contact you if your order contains incorrect information (i.e. wrong protocol or site number). See example below.
If the query is not answered within 24 hours for expedited / 48 hours for standard, your order will be cancelled.
This article originally appeared in 2017.