Investigator Training Ensures Everyone is on the Same Page

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.Training

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.

Investigator Site Survey
Coming Soon

survey clip artLove 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.

Avoid Dangerous Packaging:
Don’t Send Sharps to Covance

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:

diff safe for blog

How to Avoid Cancelled Orders

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.

insite blog pic 26 Jul

This article originally appeared in 2017.

Dry Ice: What You Need To Know

1) What is dry ice?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

What is Hemolysis and
Why is it Important?

red blood cellThis 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

2017 Holiday Shipping Guidelines

At Covance, we know you are busy! To simplify, we are reducing the amount of communications you receive from us regarding holiday reminders.

We will no longer be sending out multiple communications throughout the year. Everything you need to navigate the global holiday season is conveniently located in the links below.

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http://www.covance.com/content/dam/covance/pdf/holidays.pdf

Holiday+Image2

http://www.covance.com/customers/investigators/investigator-study-team/courier-contact-numbers.html

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http://www.covance.com/content/dam/covance/pdf/English_CovanceCLSContactNumbers.pdf

Remember – All Holiday reminders are available on the Covance website:

http://www.covance.com/customers/investigators/investigator-study-team.html

A Recipe For Success: Kit Substitution

kit-best-practicesThis 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

Proper AP Sample Identification

AP video picAnatomic Pathology (AP) is the study of solid tissue, and is often a critical part of many protocols. Tissue samples are used in clinical trials in addition to the usual blood and urine samples. Examples of anatomic pathology samples Covance Central Laboratory Services receives for clinical trials are tissue from the gastrointestinal and urinary tracts, endometrium, liver, skin, lung and bone marrow.

AP slide imageAccurate patient identification is of utmost importance when sending Anatomic Pathology specimens as in almost all cases, unlike blood or urine samples, solid tissue samples cannot be recollected. Therefore the audit trail must be tighter and specimen ID is held to the highest standard. Imperfect specimen ID may result in the specimen being returned to the investigator site.

Tissue samples can be submitted in various forms; Wet tissue, Tissue in a paraffin block, or Tissue on a slide.
Some tissue samples are newly obtained from patients during the course of a clinical trial. These fresh samples are normally submitted “wet” in formalin.

They are identified with the barcode accession number affixed to the Covance CLS provided sample container and the Patient ID written on the label and the requisition. Be sure to write the patient ID using indelible marker on the accession label that matches the requisition.AP bottle image

Some tissue samples may be submitted from an archive of tissue samples from a patient. These archival samples may be already labeled using local hospital or clinical procedures. When the Sponsor wants to use these tissues for analysis, it is extremely important to provide a durable and defensible audit trial….tying the local patient identifiers to the Covance accession number used in the clinical trial.

 

tube with slide for AP blog articleSome tissue samples may be submitted from an archive of tissue samples from a patient. These archival samples may be already labeled using local hospital or clinical procedures. When the Sponsor wants to use these tissues for analysis, it is extremely important to provide a durable and defensible audit trial….tying the local patient identifiers to the Covance accession number used in the clinical trial.

Archival AP samples are normally submitted along with a copy of the local pathologist’s report which includes the sample’s local identification. Use the extra accession label from within the Covance CLS kit and apply it to the local lab report. This ties the local lab report to the clinical trial. Handwrite the patient’s clinical trial patient number or initials on the label. Also, be sure to use a black marker to obscure any confidential information such as patient’s name, address, social security number, etc.

In a sampling of specimens received at Covance CLS, we found AP sample identification errors to be 10 times the error rate for blood and urine samples! In order to preserve unique tissue samples we want to share successful practices with you. These will reduce the error rate ensuring the sample can be used for inclusion and analysis in the clinical trial. Please review the eLearning on Anatomic Pathology Sample ID for tips in proper labeling to prevent common sample identification errors. 

By working together, we can reduce specimen identification errors and increase delivery of accurate results. Careful attention to specimen identification promotes quality patient care and a successful clinical trial.

Hurricane Irma Preparations

Covance Central Laboratory Services Logistics would like to provide the following information regarding potential courier service delays due to Hurricane Irma.

Investigator Sites in Florida can expect to experience unavoidable service delays by your courier, based on the current or anticipated severe weather in your area. Although contingency plans are in place, some disruption in pickup or delivery service is anticipated by all couriers in Florida.

If your site is located in the impacted area, sample collections should be avoided if at all possible. Contact your normal courier prior to sample collection to confirm if pickup is available in your area.

If you have already drawn samples and your courier is unable to provide sample pickup, please maintain your specimens at the designated transport temperature until the next available pickup. Maintain ambient samples at ambient temperature, frozen samples in a frozen state in a freezer or on dry ice, refrigerated samples should be kept refrigerated.

Couriers will resume normal service schedules as soon as the situation allows. You can obtain further courier service weather updates by visiting your courier’s websites (ups.com or fedex.com).

If you have any questions regarding this information please contact Covance Investigator Support at 866-762-6209.