Site Selection & Release
What does TLMM stand for?
Trial Level Monitoring Manual
What visit report are you reviewing, if the site is closing? Give the name of the visit and abbreviation
Site Close Out Visit (SCV)
Who distributes the TLMM to the CTMs locally
The CTL and Site Monitoring Leader (SML)
How long do MRAs follow up on issues (protocol deviations), once, twice, or until resolution?
Until resolution
What two colleagues manage ongoing Investigator Training as per the Trial Training Plan(Site Monitoring SOP)?
The CTM & the CRA
Who writes the Trial Level Monitoring Manual (TLMM)?
The CTL and Site Monitoring Leader
What visit report are you reviewing if the visit is referring to initiation of the site?
Site Initiation Visit (SIV)
Name two local regulatory documents required for site release
1. Form FDA 1572 (IND trials) or Information Form for Research Sites (Non-IND trials) 2. HIPAA Authorization (if not embedded in the ICF) 3. Lab/Diagnostic/Testing Facility Certification/Accreditation 4. Lab Reference Ranges 5. IEC/IRB Roster(s) 6. IEC/IRB Approval for all Recruitment/Retention materials & Social Media Campaigns 7. Financial Disclosure(s) for all Sub-investigators listed on the From FDA 1572
How do MRAs and CTMs capture contacts with the site on specific topics (i.e., Late SAE report, CAPA follow up conversations)?
They complete a Site Contact (email/Word document) capturing discussion
Which colleague in the local trial team is a resource for the CRAs whenever they have questions regarding their CRA activities?
Site Monitoring Manager
What does CDA stand for?
Confidential/Secrecy Disclosure Agreement
What visit report are you reviewing if the visit describes site monitoring?
Site Monitoring Visit (SMV)
True or False
Are the options for CRAs to respond to visit report questions:
N/A, Yes, & No
True these are the options at every section of the visit report
Who in locall trial team is reviewing issues submitted in Issue Mgt. by the CRA?
CTM/MRA
* Remember Site Monitoring Lead is on the trial level reviewing all for the trial
Who identifies sites that have to be closed before database lock (DBL) throughout the trial?
The CTM
Who is responsible to ensure there is a CDA in place prior to the sharing of any proprietary information with the site staff?
The CTM and the CRA
What visit report are you reviewing if the site is being looked at for possible selection?
Site Qualifying Visit (SQV)
What checklist must be completed by the CTM before CRAs can complete a SIV?
Site Initiation check list
Who on the trial team is reviewing issues submitted in Issue Mgt. by the CRA?
The Site Monitoring Leader
What does CTSU stand for?
Clinical Trial Supply Unit
Based on what visit report do the CTMs make the decision to select or not select a site for the trial?
The Site Qualifying Visit (SQV)
How do CRAs capture contacts with sites in between normal monitoring visits?
CRAs create Site Contact (email/word document) * MRAs and CTMs capture the same way
What document does the CRA follow to assist them in conducting visits along with the global HTG that describes specific aspects of the trial?
Trial Level Monitoring Manual (TLMM)
What two colleagues manage ongoing IMP and AxMP supplies at the site during the trial per Site Monitoring SOP
CTM & the CRA
Can a Severe Issue originate from a Protocol Deviation, Fraud, Misconduct?
Yes! Per the HTG on Issue Management