15 - Specimen Overdue System - FAQs

Owned by Bijoy George
Last updated: Feb 09, 2024
5 min read

Effective March 1, 2023, to ensure that all scheduled, mandatory biospecimen submissions related to Alliance clinical trials are complete, the Alliance BioMS system will begin to generate and send automated email messages to remind clinical sites of any potential overdue and mandatory biospecimen submissions. Please find answers to the most common questions related to this new effort below. If you have questions that are not answered below, please contact Alliance Specimen Reporting at Specimen Reporting

 

  • Why am I receiving an SOS notification?

    BioMS will automatically create an email overdue notification for any Alliance trial biospecimen that meets all of the following conditions. 

  1. Defined in the protocol as a mandatory submission 

  2. Is a scheduled submission based on the participant registration date and the study calendar

  3. Has not been marked as collected (either the primary specimen or protocol-defined alternate specimen ) by the anticipated collection date plus a ‘grace period’ which is defined by the protocol and specimen type. 

  4. Has not been marked in BioMS as "Not Collected" with the appropriate reason selected. (Sometimes, it is possible that sometimes Mandatory specimens cannot be obtained and it is allowed as an exception)

  5. And You were the last CRA who collected specimens on the study from your site.  

  • How does the SOS determine a specimen is overdue? 

      If the expected collection date of the mandatory specimen is less than the first day of last week and specimen has a "Pending" status, the specimen is considered overdue. 

  • Who all are included in the Potential Overdue Specimens email?

In addition to the CRA responsible for the specimen collection, Collection/Registering site’s Lead CRP is copied on the email notification.

  • I received an SOS notification but I am not responsible for this patient or study. What should I do? 

BioMS sends emails to the last registered CRA who submitted a specimen for the specific trial at the specific institution.  If you are no longer responsible for patients on the trial, please forward the email to the appropriate individual and contact alliancespecimenreporting@email.wustl.edu  so that BioMS Team can take necessary actions if possible.

  • I received an SOS notification for a patient who is not or no longer (Patient off study)  on this trial. What should I do? 

Notifications from BioMS are generated based on patient registration status in Rave.  If you are receiving notifications related to patients who are not on the trial or are no longer on the trial, please make certain that their registration status is properly updated in Rave.  In this case, the patient status should be updated as Patient off study and not Patient off treatment. Note that if a patient is no longer on the trial, depending upon the reason, previously expected specimens may still need to be submitted and will therefore be considered ‘overdue.’ 

  • I received an SOS notification for a patient who is off treatment (Patient off treatment) on this Trial. What should I do? 

Notifications from BioMS are generated based on patient registration status in Rave.  If you are receiving notifications related to patients who are off treatment (Not Off Study)  on the trial, please login to BioMS and mark the mandatory overdue specimens as "Not Collected" and select an appropriate reason. Please note that the SOS notifications will not stop until the overdue specimens are updated with the "Not Collected" status in this scenario. 

  • I received an SOS notification for a specimen that I already submitted. What should I do? 

Please confirm that the submitted specimens was properly logged in BioMS under the correct study, patient, timepoint, and specimen type.  If a specimen was incorrectly logged in BioMS, please contact the BioMS Help Desk to resolve this issue. 

  • I received an SOS notification but I am not able to submit the specimen.  What should I do?

If you are unable to submit a mandatory specimen or its alternate (if applicable) because of physical or logistical limitations, institutional policy, or patient refusal, please log the specimen in BioMS as " Not Collected" select the reason for why the mandatory specimen could not be collected. Please contact the BioMS Help desk if you need help marking a specimen as Not Collected 

  • I received an SOS notification on a repeated specimen collection in a Study (same specimen type collected at regular intervals) but I see that the specimen was collected. What should I do?  

If you accidentally clicked on "Add More" event more than once under the same timepoint in BioMS, it is possible that it might have created a duplicate specimen. Please reply to the email and communicate the same and we will remove the duplicate specimen and that will stop you from receiving any further notifications on the same specimen. 

  • I received an SOS notification for a specimen that is not collected; however as per the patient's last visit date, specimen is not yet due. What should I do? 

You have no immediate action to take. We understand that patient visit can be delayed due to various factors. The SOS notification is based on the patient's registration date and the standard study calendar. Sometimes these dates can be off depending on the patient’s treatment schedule. Once the specimens have been collected, the notifications will stop. 

  • I submitted a specimen that was deemed ‘unacceptable.’  Will I still receive an SOS notification? 

No.  Specimens that are submitted but deemed unacceptable are not considered ‘overdue.’  Performance scores for biospecimen receipt quality and submission of mandatory specimens are independent metrics that are tracked by BioMS. 

  • I received an SOS notification but submitted the specimen in response.  Will it still be counted as ‘overdue’? 

For institutional performance monitoring and reporting, ‘overdue’ specimens are accounted for only twice each year (March and September).  If a specimen is marked overdue but is resolved before the close of the reporting period, it will not be considered overdue.  Note however that some specimen requirements must be collected within a specific window of time and if they are not collected within that time frame, they will be considered as ‘not collected’ and cannot be resolved. 

  • How do I stop SOS notifications? 

An SOS notification will cease when any of the following conditions are met.

  1. A specimen is collected and received by the appropriate biobank OR 

  2. A patient who has been removed from the study is properly updated in Rave  as Patient Off Study OR

  3. The specimen is marked as ‘Not Collected’ in BioMS with a selected reason 

  • How do I review Overdue Specimens for my site(s) using BioMS? 

There is a newly added option to search, view and download a report on Overdue specimens for a Patient ID OR a Study on the BioMS Graphical User Interface. You can find this option under SEARCH on the BioMS Side Navigation Menu. User can also download a report on Overdue specimens based on the selected search criteria  which can be All specimens OR for a Patient OR for a Study. To learn more about the BioMS GUI function for Overdue Specimens, please visit the Overdue Specimen Search/View/Report Function Details page.