Data
Name the tool to be used to determine which subjects you will SDR at each onsite visit
Workload Forecasting Tool (in RAVEN)
Where do I complete my Ongoing Site Risk Leveling?
In IRIS - Onsite Monitoring Visit Report - OsRL tab
Veeva-Any Site Monitoring Event (onsite or virtual, or continuous)
I have to complete a site risk leveling for my RMV
True or False?
False,
it is not required to complete a risk leveling for your RMV
In Veeva-all site monitoring events will require site risk levelling
SDR = Transcription check between source and eCRF
SDV = Review of subject source to ensure site compliance to GCP and protocol
True or False?
FALSE, opposite
Where are the dashboards and reports used for RBQM oversight located?
RAVEN and CDA-reports in IRIS
Where can you see which data points need to be SDVd?
RAVE (eCRF)
Provide 2 examples when an override of the OSRL could be justified
Multiple GCP violations, Trending or multiple deviations/issues, Source documentation not done as per GCP or Study Requirements, Site is not following basic standards of conducting clinical research (ICH GCP), etc.
The PI is expected to be available for all Remote Monitoring Visits?
True or False?
True,
Just like an OMV, the PI is expected to be present
Where is SDR and SDV documented?
SDR: IRIS SDR tab
SDV: In RAVE (eCRF)
How do I get access to RAVEN?
Complete RAVEN overview training in My Learning
Complete a PRIMA4PWP request with studies you need access to
The CRA should not look in the eCRF for patients that are not selected for SDV
True or False?
False
The CRA should check the eCRF for completeness (as well as other sources such as IRT, Lab or Other vendors). This can be done remotely!
When do I complete my first Ongoing Site Risk Leveling?
After FPFV
A Follow Up Letter needs to be completed after an RMV and sent to the site
True or False?
True,
an RMV is a formal visit and requires a FUL, same as an onsite visit
What determines SDR:
Study Risk Leveling or Site Risk Leveling or Both?
SDR is determined by both the study and site risk level
I have an RBQM/RAVEN related question, where do I go? Give 2 examples
RBQM Sharepoint (FAQ and RBQM Manual)
RAVEN Sharepoint (RAVEN RBQM Maturation Guidance Part 1 & Part 2)
Contact my RBM Leader / RAVEN Super User
Use support email: RBQM@bayer.com
In what dashboard can I look for trends regarding the Site Risk Level and the individual site risk indicators?
Raven OsRL Dashboard (site level)
Give 2 of the benefits you get by reviewing the site risk indicators on a regular basis, instead of only at the time of ongoing site risk leveling.
Notice trends.
Follow up with the site staff in a timely manner.
Notice issues before they become severe.
Become aware of your sites' status performance.
Compare how your sites are performing against other sites in the country/study.
Reviewing data that can support your decision-making.
Discover what to focus on.
Are you expected to conduct remote SDV during an RMV - Yes or No?
No
However if you have access to the EMR and local regulations allow, you can conduct these activities during your RMV
If the ratio of SDR has increased due to increased site risk level - should additional patient's source data be reviewed from that study visit onwards or should it be reviewed from the first visit the patient had in the study?
The patient should be SDRd from the very beginning of the study.
If there is a red indicator in OsRL what should you do?
Identify the root cause, deep-dive into RAVEN, take action to address and add a comment in the OsRL and if appropriate create an FUI/PD
Where can I find what is considered "Critical Data" for my study?
The IDRP (Integrated Data Review Plan)
Name 3 of the 8 Ongoing site Risk Leveling Indicators
Data Entry Timeliness, PI Oversight, Query Volume, Query TAT, Query Aging, AE Incidence Rate, PD Volume, FUI Incidence Rate
Name 3 things that are to be assessed during a remote monitoring visit
PI oversight and site communication, Ongoing review of FUIs and PDs, Training / Resources, Patient enrollment and retention, Clinical supplies/lab data, AE/SAE repoting, Adherance to Mon plan and Protocol, Training, Resources, Data Entry Review, Query resolution etc.
Name 3 other data reviews that are done on eCRF data, besides SDV by the CRA
Edit checks, DM review, ME review, CDR, PV review (SAE data)
Name two roles that perform central data review.
Data Manager, Statistician, Central Data Reviewer, core study team