9 - Alliance BioMS Contingency Plan

Normal Hours of Operation

1) 7am to 7pm Central Standard Time is the expected normal operating hours for the BioMS application.

Scheduled System Maintenance

1) Upgrade, update or other system operations that might render the system inaccessible for a period of time

2) Only occurs outside of the BioMS normal hours of operation

Unscheduled Downtime

1) Unscheduled downtime, which may occur due to hardware, software, or networking failures and may cause partial or complete loss of access to system resources, can result in the system and/or servers being unavailable.

2) May occur during the BioMS Normal Hours of Operation.

Scheduled Downtime

1) Scheduled downtime will never occur during normal hours of operation.  As such, notification of scheduled downtime outages will not be communicated to end users directly.  A list of dates and times that the system will be offline may be posted on the BioMS webpage for reference. However, if there is an enhancement to the application, the details will be communicated to the users.

Unscheduled Downtime, anticipated to be less than two hours

1) Unscheduled downtime which is anticipated to be less than two hours in duration, will not be communicated to end users directly.  Users who experience difficulties due to unscheduled downtime during normal hours of operation will contact the BioMS help desk.  It is recommended that collected specimens be processed as per protocol, but held for biospecimen logging and shipping in BioMS in anticipation of system restoration.  An exception to this rule may be when a biospecimen is required for same day shipment and shipment must occur within two hours of the time of collection (e.g. a biospecimen is collected at 5 PM to be processed, packaged, and shipped for a 7 PM courier pick-up deadline).  In this case, the procedure below should be followed.

Unscheduled Downtime, anticipated to be greater than two hours

1) Notification of unscheduled downtime which is anticipated to be greater than two hours will be posted at the following locations

http://www.allianceforclinicaltrialsinoncology.org/main/

https://www.allianceforclinicaltrialsinoncology.org/main/member/standard.xhtml?path=%2FMember%2FBMS

tinyurl.com/BioMS-Help

This direct notification to end users will also occur via the Alliance listserv.  End users will be advised to follow the protocol described below.

Unscheduled Downtime Procedure-Collection Site

1) End users collecting and shipping biospecimens during BioMS downtime must adhere to the following procedures.

Collection Site

a)  Reference the hard copy of the protocol as well as the Correlative Science Manual (CSM) for specimen collection and shipping requirements. 

b)  Complete the BioMS Specimen Log and Shipping Manifest form.

c)  Package specimens in accordance with the shipping details provided in the Protocol/CSM.

d)  Send shipment to the designated repository, in accordance with the protocol details

e)  Email a scanned copy of the completed BioMS Specimen Log and Shipping Manifest form to Bioms@alliancenctn.org for data entry into BioMS when the system is available.

Unscheduled Downtime Procedure Repository

a)  Upon receipt of package from a collection site, the repository will follow their site-specific downtime procedures.

Upon Restoration of BioMS

a) BioMS help desk staff will log all manually processed biospecimen accessions into BioMS based on electronic / paper forms received.

b)  Biorepository/Assay Lab staff, will log receipt of biospecimens in Open Specimen as per normal operations.