Show:
CATEGORY 1
CATEGORY 2
CATEGORY 3
CATEGORY 4
CATEGORY 5
100
Who is responsible to complete a form in order for the trial team to utilize the global emergency unblind vendor?
The TCM
100
What is the purpose of an Investigator Meeting?
A specific professional and educational goal, to ensure a common understanding of: Protocol, Trial Management, & GCP Responsibilities
100
Who is the responsible for logging any versions of local documents that will be added/or adapted in the local ISF?
The CML/MRA will adapt the TOC of the ISF to reflect all modifications & notifies the TCM
100
Who must be present at the TIV?
The investigator must be present at the TIV
100
What form can the CML/MRAs utilize to document important conversations they have with the site staff & PI?
The Site Contact Report
200
What is the name of the global vendor who provides backup unblinding information when the PI is not available to provide unblinding information to an ER MD?_____
ESMS
200
Who is responsible to run the Local Investigator Meeting?
The CML
200
What form does the CML/MRA complete in Legacy process to release IMP
The Site Release Form. The CML does not complete this form until they have ensured that: Step 1= Confirm IMP/AMP prerequisites under the Quality Person/Clinical Supply Review Officer for IMP are complete (Certificate of Conformance & Certificate of Analysis for IMP) Step 2 = Confirm competent authority (IRB/IEC) approval is in place prior to release of IMP/AMP
200
Can the CRA complete the TIV if the investigator has not received training or attended an investigator meeting?
No
200
Who are the members of your local trial team?
The CML, Manager, & CRAs
300
Can the PI unblind via the IVRS?
Yes and this is how they should unless the trial uses scratch cards or envelops
300
What is the purpose of the initiation visits?
The purpose of initiation visits is that they ensure the investigators have the required items to enroll subjects such as: Information/training Trial material/equipment Essential documents Investigational product Access to systems
300
What does the CML/MRA complete to release IMP in BICTMS PROGRESS system?
The CML/MRA complete the Site Initiation Checklist. This is not done until the Step 1= Confirm IMP/AMP prerequisites under the Quality Person/Clinical Supply Review Officer for IMP are complete (Certificate of Conformance & Certificate of Analysis for IMP) Step 2 = Confirm competent authority (IRB/IEC) approval is in place prior to release of IMP/AMP
300
Who presents training to investigators who could not attend the investigator meeting?
The CML/MRA
300
Name one method of monitoring?
Direct Site, Vendor Reports, Periodic visits, Remote Monitoring/Risk Based Monitoring
400
Do the Trial Investigator Cards (TIC) have the contact information for the PI on them? Yes/No
Yes and this is who the ER MD should call first when given the TIC card
400
Give me three things that the CML/MRA need to make sure are in place prior to releasing sites for initiation
Prior to the first local site initiation, the CML/MRA ensures that the following are available or in place: Fully executed contracts Regulatory Release Signed Monitoring Manual Written approval of the IRB/IEC and competent authority Local Investigator Meeting (IM) to prepare the trial team for initiation Investigator Site File (ISF) at sites CML/MRA authorized release of IMP to the country/sites
400
Name one of the systems that CMLs/MRA have to be sure the site staff are trained on and have accounts?
BRAVE,CLINERGIZE, RDC, etc.
400
What system do the CMLs go into to review CRA visit reports in the new BICTMS process? Bonus Question: What system do the CRAs go into to doucment visit reports in the new BICTMS?
PROGRESS Bonus Question: What system do the CRAs go into to doucment visit reports in the new BICTMS? = MySites
400
What is the name of the webpage where you could find information about Risk Based Monitoring?
RADAR
500
Are the TIC cards now being created with an insurance card sleeve?
Yes
500
Who provides the CML with the ISF?
The TCM gives the ISF to the local CMLs no later than 8wks prior to Trial Initiation
500
Do the CML/MRAs have any responsibility in regards to the Monitoring Manual?
The CML/MRA and Manager are responsible for: Adding local monitoring manual adaptations to Section 8 Distributing & training for local trial team Recommending any additions or revisions to TCRA or TCM CML/MRA are responsible for signing & filing local adaptations in the TMF
500
Is it true that the CML/MRA and CRA are responsible for monitoring the sites to ensure that the trial is conducted according to ICH GCP?
Yes!
500
Is it true that the CML/MRAs must keep a log of all Protocol Violations for the length of the trial?
Yes. CML/MRA advise the TCM of all new manual protocol violations(MPV) as they are made aware of them via visit reports by the CRAs