Site Selection & Release
The PI must complete TransCelerate approved ICH/GCP training within how many years from the SIV date?
3 years
The Site Monitoring Framework will consist of what 3 elements?
Onsite Monitoring, Remote Site monitoring, Centralized site monitoring
When conducting a remote SIV, which parts of the reports are not required to be covered?
Trick question - they are all required!
What document should the CRA reference to confirm training requirements?
Trial Training Plan
When is remote source data verification and review allowed?
The CTM/SML will give the CRAs the directive of when remote SDV is allowed, whether in the TLMM outlined in risk based monitoring OR an email communication outlining the length of time that the study is moving to remote SDV/SDR (i.e. COVID-19 procedures)
What does SDSR stand for and when should it be completed?
Source Data Status Report form and at the Site Qualification Visit
TRUE or FALSE: Regarding Patient Health Information (PHI), in cases where personal data is accidentally received, the information must NOT be deleted or obscured?
False, it must be deleted or obscured
In the SIV report, where would you indicate if the visit was conducted on-site or remotely?
The Visit Details Summary
CRAs are responsible for entering site staff end dates in MySites at closeout. What is the end date for PI and Regulatory Coordinator? What is the end date for all other site staff?
PI/reg doc coordinator: SCV plus 6 months 2. all other site staff: SCV plus 30 days
How does a CRA respond to a Site Risk Review issue?
Investigate and either open an admin issue, open a PD issue, or clarify why no action is needed prior to closing the SRR issue with a note to reference the new issue number, if applicable.
Which FUL is provide to the CRA via email to then provide to the site?
FUL for Site Qualification Visit
TRUE or FALSE? The SMVR should be completed and finalized in 10 weekdays?
False: The SMVR should be completed and finalized in 5 weekdays.
Who is responsible for finalizing the Enrollment Hold Letter at the end of the SIV?
The CRA
How is the SAE Form submitted?
via fax
How do CRAs conduct a remote visit without access to source documentation?
Review all study portals and systems (EDC, Clinergize, IRT, study specific portals) and review data for entry, cross-referencing CM, Med Hx, AEs, visit windows, reported SAEs, acknowledged documents in Clinergize, missing uploads, TTL vs. TSL. All outlined in TLMM
Which visit report is expected to contain robust and detailed comments?
Site Qualification Visit Report
Name 2 example criteria of how to assess PI oversight?
Accessibility to PI, involvement in consent process and/or AE/SAE assessment, assuring site staff training, documentation of subject oversight in source, inappropriate delegation of responsibilities
How are the finalized SIV Report and FUL provided to a site?
via Clinergize (CRA must upload the finalized SIV report to TMF Staging Area)
Where can the Always Serious AEs list be found for the site?
ISF and/or included in BRAVE
What does RBSM stand for?
Risk Based Site Monitoring
What does ALCOA stand for?
Attributable, Legible, Contemporaneous, Original and Accurate
Name 2 of the questions CRAs should ask at the start of the SMV?
1.Subject status changes
2. SAEs
3. Screening/Enrollment
4. Deviations, IMP Issues
5. Facility changes
6. Staff changes
When should a CRA enter the ‘ACTUAL’ Site Initiation Event Date in MySites?
After the visit is completed and before starting the SIV report in MySites
Name 2 options for rSDV
1.Direct, remote electronic access to the site’s source records 2. Video call with site staff showing source documents to CRA or Phone conversation with site staff reading source document content to CRA 3. Electronic copies of source documents provided to CRA via site-owned secure document exchange platform 4. Electronic copies of source documents provided to CRA via email
Name three of the primary functions of MySites?
1. Issue Management 2.Checklists 3. Monitoring Visit Reports 4. Event Dates 5. Site Staff Dates