Roles
Processes
Processes
Temp Excursion at site
Processes
100
Who is responsible for packing, labelling,distributing logics of IMP?
CTSU
100
Is it true that the sites have to complete two Proof of Delivery (POD) steps to accept drug for IRT trials?
Yes this is true
100
If the Site looks at box of IMP being delivered and the outer box is perforated and wet can the site decline to receive the drug?
Yes! The site would not accept the IMP and they would not sign POD. Courier will return IMP to CTSU
100
What does it mean that a Non-Significant temperature excursion occurred?
The IMP at the site had a temperature excursion but outside the label recomendations but the excursion was within the STORM document range.
100
What do sites do that have temperature excursions at the site but do not have STORM documents?
The sites document the temperature excursion on a PDCF and send to CTSU Complaint Mailbox. Medication is quarantined and sites register the IMP in IRT as quarantined & wait for instructions from CTSU
200
Who is responsible to sign for Proof of Delivery (POD)
The sites
200
Is it true that the sites have to plug in the data logger to USB ports of computers and send protected data on temperature logger or Elpro to CTSU (bi@liberomanager.com)?
Yes! On page 16 of Corp SOP Management of Investigational Medicinal Product.
200
Does the CRA check the IMP storage and temperature monitoring during their visits?
Yes the CRAs continually check the IMP as it comes in and compares kit # on paper work with IMP to the actual kits received by the sites.
200
What does it mean if IMP temperature has a Significant temperature excursion?
This means that the IMP at the site suffered a temperature excursion beyond the label recommendations & beyond the STORM document's range
200
Who is responsible for obtaining a Certificate of Destruction from the site when drug is being destroyed at the site?
The CML
300
Who is responsible to check IMP when they visit to ensure it is stored in an appropriate dry safe place ?
CRA
300
What does the site have to do if during IMP transport the Temperature logger is missing or malfunctions and ther is no data to transfer to bi@liberomanager.com.
Site has to complete the Product DeviceComplaints Form (PDCF). Site sends the Form to CTSU Complaint mailbox (manual PDCF). Site would quarantine the IMP, register IMP in IRT as quarantined, & wait for instructions on status of IMP by CTSU. They will send a copy of POD form to CTSU with PDCF
300
Is it true the sites must complete a temperature log on site and must be completed by the site?
Yes. The CRA should be checking this to ensure no temperature excursions. The temperature monitoring by the site should be occurring weekly
300
What form does the site have to complete if the IMP stored at the site has a temperature excursion beyond the label recommendations and is a Non-significant temperature excursion per the STORM documents at the site?
The site would complete the Drug Storage Temperature Excursion Report and Assessment Form. The IMP is considered by CTSU fit for use as it is within STORM document's range
300
The Distribution Partners are destroying drug for BI who sends them a Destruction Authorization form?
The TCM
400
Who is responsible that information regarding when the drug must be utilized by is available at the site? (hint this is the person who is your line manager in regards to trial activities)
CML
400
If there is a temperature excursion and CTSU states IMP without a Temp logger must come back & new IMP sent to the site. Who updates IRT system with new IMP kit numbers for this site?
CTSU will do this
400
Is it true that if the CRA comes to a site and see they missed a weekly temperature monitoring of IMP that they have to treat this as a temperature excursion?
Yes! This is a requirement. If the CRA at a visit notices a temperature monitoing recording missing this must be reported and treated as a temperature excursion
400
What forms does the site complete if the IMP at the site is exposed to temperature excursion that is Significant per the STORM documents?
The sites completed the Drug Storage Temperature Excursion Report and Assessment Form and completes the Product Device Complaint Form. The site sends both forms to CTSU Complaint Mailbox. The IMP is quarantined. IMP will be returned & IMP will be replaced by CTSU
400
Who makes the final decision on site to site transfer of IMP?
The TCM
500
If there is a temperature excursion during transport of the drug to the site, what device will indicate this that is in each box of IMP?
The Elpro Logger
500
How does the Site handle opening a box of IMP that is damaged upon opening?
The site completes a PDCF & sends to CTSU complaint mailbox. Site stores drug as quarantined , registers the IMP in IRT as quarantined. The POD and temperature data will be provided with PDCF. Site would return unusable IMP & CTSU will initiate replacement
500
Who is responsible to ensure that the trial specific STORM documents are at the site along with the Product/Devisce Complaints Form, Drug Storage Temperature Excurstion Report and Assessment Form?
The CML
500
Who is responsible to update the IRT system when IMP at the sites are quarantined and sent back to Clinical Trials Supply Unit.
CTSU will update the IRT system when drug is quarantined and new drug sent to site as replacement.
500
Who should you notify immediately if you are made aware of a Product Complaint around IMP?
The CML
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