Systems
What system presents dashboards of date for a high level determination on how the trial is doing?
Clinsights
What document has to be in place prior to CTM/MRA sharing proprietary information with the sites?
CDA Confidentiality Disclosure Agreement
If all prerequisites are in place, who notifies the CRA that the SIV may be conducted?
CTM
What does IRT stand for?
Interactive Response Technology
Who receives alerts if the sites do not open and acknowledge the IMP in the IRT system?
CTM and CRAs and Investigators
What system do the CTMs utilize to run a subject list for reconsenting?
BRAVE
What does SFQ stand for?
Site Feasibility Questionnaire
What is the name of the report used by the CRA to Report the SIV?
Site Initiation Visit Report (SIVR)
Is Almac one of our medication distribution partners?
Yes!
When do the sites receive the tape to tape the boxes for returns?
They receive it when they receive their first box of IMP only.
What system do you need to be compliant with so that you do not end up on the non-compliance list?
LOS
Who makes the final site selection of the providers to be utilized in the trial?
CT Manager
What does TLMM stand for?
Trial Level Monitoring Manual
What does it mean for CTM to meet Regulatory Green Light?
The CTM has met all HA, IEC, & IRB approvals
If the site has a temperature excursion with their medication beyond the STORM parameters, what do we usually ask CTSU to do?
Ask CTSU to send the site more drug because the CTSU response for drug that had temperature excursion response could take up to 30 days.
What is the name of BI portal system?
Clinergize
Do the CTMs have to notify sites that are not selected?
Yes! Per the SOP the CTMs notify PIs of acceptance and non-selection with site selection and non-selection letters
Can the MRA run the issues report from BICTMS?
Yes, if delegated, the MRA may run the issues report from BICTMS and distribute to the CTM
Who checks at the site that the drug is stored correctly and the accuracy and completeness of IMP is correct?
CRA
Would you notify the DPO & Process and Control team if you received a patient's bill sent to you by a site and you redacted and destroyed the document and contacted the sender to advise they sent you a document with PHI on it?
No! You did what you should by redacting and destroying the document
What system do CTMs/CTLs enter their time spent on clinical trials in?
Journyx
How do the CTLs communicate the training the sites need for the trial on the country/local level? What do they give to the CTMs/MRAs?
Trial Training Plan (TTP)
Is PI oversight required in a Clinical Trial?
Yes, PI oversight in a clinical trial is required by law and regulations
What would the site do with IMP if it was damaged on transfer or was outside its temperature excursion?
Quarantine the Drug
Would you contact the DPO & Process Control teams if you received a document with PHI from another MRA in BI?