A specific criteria needs to be met in order for reflex testing to be ordered. If the criterion is met, the testing happens automatically. If the criterion is not met, the testing is not performed. A common example is the Beta hCG test. If the answer to the administrative question “is female patient of childbearing potential?” is marked yes, the Beta hCG would reflex and the testing would be performed. If the answer is marked as no, the testing would not be run since the criterion was not met.
Frequently Asked Questions
Do I need to order Reflex Testing?
Why did I get a QNS Report?
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
What temperature should I store my kits?
To obtain the highest quality specimens possible, it is recommended that all collection supplies be stored between 4°C to 25°C (39°F to 77°F).
What are blank or Bar Reqs?
Blank requisitions, or Bar Reqs as they are frequently called, are included in your laboratory manual (toward the middle to end of it). These can be used as a reference, replacement requisition, or included when building a kit using your own supplies. Remember to photocopy the blank requisition before using it to ensure your original stays intact.
How can I get my laboratory reports?
We can only provide results by three methods:
- Xcellerate Investigator Portal
Results cannot be provided by other means, such as email, text or pictures. Generally, studies are set up to provide results by one or more of the above listed methods according to the sponsor request. For more information, please contact your local Investigator Support Team at the number listed for your region in the laboratory manual
What do I do when I receive a panic alert?
If you received a fax or voicemail concerning a High Panic or Low Panic lab value please respond to your local Investigator Support team as soon as possible to confirm receipt. Failure to do so can result in an escalation to the sponsor. Investigator Support can be reached by phone, email and fax.
The phone number and fax numbers are located in your Lab Manual.
The email addresses are as follows:
The Americas: [email protected]
Europe, Middle East and Africa: [email protected]
Asia Pac: [email protected]
Are new reports sent following a data revision?
If a data revision has been requested for a change of collection date, time, weight, visit, etc., the request may take up to 10 business days.
Once the change is complete, sites will be notified by fax. A new report will not be sent. If a new report is needed, please call us at the number listed for your region in the laboratory manual.
Can I change my kit order once it is placed?
Unfortunately, no; we cannot modify existing orders. Your order will have to be cancelled and a new one placed. This also applies to timelines. If you placed an order with standard turn around times and now need it sooner the original order will have to be cancelled and a new one placed with expedited timelines.
How to update your site’s contact information?
Contact your regional Investigator Support Department (the number can be found in your Central Laboratory Services Manual). When calling, inform the representative if the changes affect a single protocol or multiple protocols. If more than one protocol is affected, please have a complete list of protocols and the specific contact information (phone numbers, fax numbers, physical address, email addresses, Principle Investigator, Report Recipient and/or Supply Recipient) to be changed.
By securing updated contact information for all protocols during one phone call, we hope to decrease the time you spend calling us and increase the accuracy of contact information we have on file.
How do I order more kits and or supplies?
Our web kit ordering tool (http://www.covance.com/kitordering) is the quickest and best way for sites to order supplies.
Once you receive a confirmation email that your order has been received, please allow 9-11 business days for your order to be delivered.
Please remember that we do not overnight orders.
Expedited orders can take between 3-5 business days for delivery once the order is submitted. The kits are custom built for each protocol and site, and sponsor approval may be required prior to expediting an order. As a result, a minimum of 3-5 business days are needed to fill your site’s order.
Orders can also be placed by calling:
North America 1-866-762-6209 Indianapolis, IN, USA
Europe +41 58 822 7901 Geneva, Switzerland
Asia (except China) +65 6560 8793 Singapore
China 800 820 85 92 Shanghai, China
How do I request a data revision?
To request a data revision (change to collection date or time, patient gender, etc.) please contact your local investigator support office. Please remember that this request can take up to 10 business days. Once the change is completed, a fax notification will be sent to the investigator confirming the revision has been done. Once the change is complete, sites will be notified by fax. A new report will not be sent. If you wish to receive fully amended reports please contact your investigator support team.
What is a Sample Pending Arrival Report (SPAR) Report?
This report is designed to assist in the management of frozen samples. It reflects the status of samples in our database at the time the report was generated. There may be some lag time so there may be items appearing on the report that were recently returned to us. We do not require that you contact us upon receipt of the report. If you have samples in your freezer, please return them to us.