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IMP
IMP
IMP
IMP
IMP
100
What are the responsibilities of the CRA in regards to the "IMP Return Form"
The CRA with site staff prepare the form. The original is attached to the shipment, a copy is placed in ISF, and another copy is filed in TMF
100
In the case of onsite destruction, who must obtain the CoD from the sites?
The CML must obtain the CoD and forward to the TCM
100
Is it true that copies of the signed IMP Transfer Form must be filed in ISFs of both sites when site to site transfer is occuring?
Yes this is true
100
Who teaches the site to complete the Product/Device Complaint form and assist them in completing it when a product complaint is suspected?
The CRA
100
Do we ever perform mock recalls?
Yes we do this to ensure IMP documentation allows complete traceability of IMP. Typically medication kits are not physically returned during the mock recall
200
Is it true that the CRAs must ensure that the boxes with returned IMP have tamper evident seals?
This is true. For studies supported by DPs tamper evident seal is provided with the initial IMP shipment
200
Where does the TCM file these certificates of destruction?
In the TMF
200
Is it true that we have a "Site Relocation Form" if a site relocates that must be completed to allow for future IMP shipments?
Yes there is a form that must be completed if we run into this situation
200
Besides the site sending in the Product/Device Complaint form when suspected product complaint the CRA also notifies who?
The CRA will inform the CML and the TCM and the TrM CTSU
200
When we perform a mock recall do we document on the worksheets involved "Mock Recall" and file them in the TMF?
Yes we do this. The TMM will decide we need a mock audit and notify the TCM who will select an OPU and notify the CML. The CML will notify the CRA of mock audit and the CRA will notify the site. All papers utilized will be labelled "mock recall" and filed in TMF
300
Is it true that in studies supported by the DPs that the DP destroys returned IMP upon receip of the destruction authorisation signed by the TCM?
Yes this is true! Usually the TCM makes the destruction decision prior to trial initiation so the DPs have the form already before the end of the trial
300
Who makes the decision to allow site to site transfer?
The TCM
300
What department is notified in parallel when there is a product complaint like all the patients are complaining of a metallic taste in their mouths?
Quality management
300
A recall of drug is initiated by who?
The DLPCO The development local pharmaceutical complaint officer
300
What form do the CML and CRA sign for each site to acknowldge the appropriate action to be taken by the site in a recall?
The "Recall of Investigational Medicinal Product Form". The CML prepares the form for each site and CRA and CML sign the original to acknowledge that appropriate action is taken by the site. The original is stored in the ISF and copy is provided to the TCM, TMM, TAH, and TrM CTSU.
400
If onsite destruction of drug is being done do the CRAs not have to worry about performing drug accountability before destruction?
This is false. Drug accountability must always be done before drug return and or destruction regardless of IRT or non IRT trial.
400
What is the CMLs role in a site to site transfer? Who do they have to notify that a site to site transfer is going to occur?
The CML will dissmenate the information that a site to site transfer will occur to local team. The CML must notify the LRA about the planned transfer
400
Is it true that if a product complaint falls into category 1 or 2 with potential recall that the TCM is communicated to the QA group and TMM and Head of Global Pharmacovigilance
Yes
400
Is it true that if there is a recall of an IMP is decided & the defect is confirmed category 1 and 2 recall potential that the TMM in cooperation with TAH and TM RA develop and provide instructions how CA and IECs and investigators will be notified
This is true and would happen in the event of recall involving category 1 and 2
400
In a recall is it true that the CML informs respective CRAs what affected kits are at the respective sites or in patients use and what action to take in a recall?
Yes the CML will reach out to CRAs to take appropriate action who will convey to investigators at the sites
500
Who will provide the certificate of destruction to the TCM if the DP are destroying drug?
The certificate of destruction (CoD) is provided by CTSU. For studies utilizing The DPs, CTSU will send CoD to TCM
500
What form will the CRA complete for a transfer of IMP from site to site?
CRAs complete the "IMP Transfer Form"
500
Do we ever re-labelling of IMP?
Yes the re-labelling may become necessary to extend use of drug by dates.
500
If there is a IMP recall does CTSU stop further dispatch of affected IMP?
Yes the TrM CTSU does stop further dispatch of affected IMP independent of the reason for recall
500
Is it true in Non-IRT trials that the TrM CTSU informst the TCM which IMP med kit numbers are under quarantine in a recall and the TCM informs the CML
This is the process for Non IRT trials.