Mix Bag
What BI acronym represents the US Monitoring Manager / Lead?
SMM - Site Monitoring Manager
The PI must complete TransCelerate approved ICH/GCP training within how many years from the SIV date?
3 years
How do you access TMF Staging area?
Type "tmf-staging" in the address bar of the web browser
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
Where can the Always Serious AEs list be found for the site?
ISF and/or included in BRAVE
If you have general questions related BICTMS, Clinergize, BRAVE or IMP/AxMP, where you cannot locate answer in BI Intranet, onboarding materials or KMED docs, who would you contact?
1- Subject Matter Experts in Site Monitoring Group
2- SMM Buddy
3-SMM Assigned to particular trial
What does SDSR stand for and when should it be completed?
Source Data Status Report form and at the Site Qualification Visit
What are the required mandatory fields that have to be completed when uploading a document to TMF
Trial number, OPU, Site number
What are the 3 formats of site visit expectations detailed in the TLMM?
1) Required recruitment calls, 2) physical on-site monitoring visits, 3) remote monitoring visits
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)
Who should you notify when a new site staff member needs access to BRAVE?
CTM/MRA
Which FUL is provide to the CRA via email to then provide to the site?
FUL for Site Qualification Visit
Site Monitoring tasks should be completed as per which of the following BI guidelines? (Select all that apply)
A. BI SOPs B. HTG (How to Guides) C. TLMM D. All of the above
In the SIV report, where would you indicate if the visit was conducted on-site or remotely?
The Visit Details Summary
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.
What is Clinergize?
A sponsor web portal used for document exchange
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.
The Site Monitoring Framework will consist of what 3 elements?
Onsite Monitoring, Remote Site monitoring, Centralized site monitoring
Who is responsible for finalizing the Enrollment Hold Letter at the end of the SIV?
The CRA
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
When subject withdraws consent, what is your responsibility and what obligations we have as a sponsor?
CRA to notify CTM with date of WoC and ensure that proper documentation is done in the source. Sponsor is to confirm that any unreviewed images and unanalyzed samples from the date of WoC are destroyed.
When conducting a remote SIV, which parts of the reports are not required to be covered?
Trick question - they are all required!
TRUE or FALSE? The SMVR should be completed and finalized in 10 weekdays?
False: The SMVR should be completed and finalized in 5 weekdays.
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?
1. PI/reg doc coordinator: SCV plus 6 months 2. all other site staff: SCV plus 30 days
The comments section of a monitoring visit report is used to capture additional information. Name two examples.
1. reason for monitoring visit frequency deviation, 2. whether the visit was conducted on site or remotely 3. name and role of site staff present at the visit but not in BICTMS 4. the dates of the visit if a multiple day non sequential visit