There were a number of comments in the 2016 Site Survey around lab reports, specifically around the number of pages sent and securing PI signatures. We thought it might help to explain the process.
Covance Central Laboratory will provide lab reports as soon as possible upon test completion. All tests have their own turnaround time – some may result and report faster than others. This is why sites may receive multiple lab reports for a single visit. We don’t want you to have to wait for patient safety results while a test that requires more work is being processed.
Other comments from the survey focused on securing PI signatures on each page of the lab reports. This is actually a sponsor requirement and not a Covance one.
Covance is transitioning to a web-based tool (eSite Access) for delivery of study-related information, including lab results, please look for more information to come as this is not yet available for all sponsors or sites.
Please contact your local Investigator Support Team. Regional phone numbers can be found in your Covance lab manual or on the Investigator Website: http://www.covance.com/content/dam/covance/pdf/English_CovanceCLSContactNumbers.pdf
To help clarify the symbols in the Laboratory Visit Schedule please see below:
-X Mandatory testing
-#X Multiple Mandatory Draws
-O Optional testing
-#O Multiple Optional Draws
-R Reflex testing
This occurs when there is not enough sample volume available to test to obtain accurate, consistent results. Sites can avoid this by collecting the amount indicated in the protocol-specific collection instructions. For additional clarification, please contact your local Investigator Support Team at the number listed for your region in the laboratory manual
Love working with Covance? Have suggestions for improvements? Share your thoughts on the upcoming Investigator Site Survey coming soon. This short survey (only 8 questions) 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, translated into nine languages and should take less than 5 minutes to complete.
Keep an eye out for the survey coming in the next few weeks. It will be emailed to all Investigator Sites.
Did you know that your lab manual includes a protocol specific Visit Schedule?
The schedule of visits will show you the sequence of visits, when the visit should occur, and what testing is performed at each visit. The schedule will also show you what testing is required (X) and what testing is optional (O). Please refer to the Visit Schedule if you are ever unsure of what visit you need to complete next.
Please note that the US Labor Day holiday falls on Monday, September 5. Please avoid sample collections on Saturday, September 3, to ensure specimens will be received at Covance Central Laboratory in Indianapolis within the established stability period,
Couriers may reserve the right to observe earlier than usual pick-up times during the holiday. Please call your local courier to obtain holiday pick-up schedules.
Send frozen specimens on the next available business day. DO NOT collect specimens with short stabilities (e.g. Lymphocyte Subsets, Reticulocyte Counts, etc.) on the days prior to the holiday.
If you have any questions regarding the collection or shipment of specimens, please consult Covance Investigator Support at (866) 762-6209.
Here are a few examples of what you can find inside: Covance contact numbers, protocol and project number, holiday schedules, specimen collection instructions, blank requisitions, result reference ranges and much more!
This is a friendly reminder that the US will be celebrating our Independence Day on July 4. Please avoid shipping sample collections on Saturday, July 2. Shipments made on July 2 will not be delivered to Covance until Tuesday, July 5. If you must ship on July 2 a premium courier will need to be arranged and sponsor approval will be necessary for the additional expense.