Dashboards/Oversight
Name one tool/system CLMs should use to keep country oversight
IRIS CDA and RAVEN
RAVE, vendor reports, IMPACT, CART, Gemstone Veeva Vault Clinical
Where can you find the study risk level for your study?
Study Site Monitoring Plan
or
IRIS CDA, study risk leveling dashboard
Gemstone Veeva Vault Clinical Study Additional Details
True or False
As a CLM, I determine the OsRL?
FALSE
This is calculated within IRIS OMVR/OsRL tab by the CRA
True or False
SDR = Transcription check between source and eCRF
SDV = Review of subject source to ensure site compliance to GCP and protocol
False
It is the opposite
True or False
It is recommended that a CRA discusses potential risk level override for one of their sites with you
True
How do I get access to RAVEN?
Complete RAVEN overview training in My Learning, complete a PRIMA4PWP request with studies you need access to
True or False:
The CLM is responsible for determining the study risk level for their country
False
This is determined by the study team
How do I compare the Site Risk of my country's sites against the other sites in the study?
In the RAVEN OsRL dashboard and in IRIS CDA (OsRL dashboard report)
Where are SDR AND SDV documented?
SDR: SDR tab in IRIS OMVR
SDV in RAVE
Which question must be answered within the IRIS report before an OSRL can be calculated?
And - how long does it take for data to be pulled to the ongoing site risk leveling in IRIS?
The question related to PI oversight & you should allow 1 day from the visit end date completed in IRIS
Name the tool to be used to determine which subjects the CRA will SDR at each monitoring event?
The Workload Forecasting Tool in RAVEN
Where is the site monitoring intervention table showing max intervals and percentage of SDR/SDV to be completed?
In the study site monitoring plan
Name 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 CRA in a timely manner
Notice issues before they become severe
Become aware of your country and sites' status performance
Reviewing data that can support decision-making
Discover what to focus on
Where can I find what is considered critical data for my study?
Integrated Data Review Plan (IDRP)
If I have an RBQM/RAVEN question, where do I go? Provide at least 2 answers
RBQM SharePoint
RAVEN SharePoint
RBQM Manual
RAVEN RBQM Guidance
Use the RBQM support email (rbqm@bayer.com)
Contact my RBM Leader, RAVEN super user
RAVEN Open Clinics
Which risk indicator in RAVEN can you look at for the distribution of AEs in your country and to see trends as well as how individual sites compare to other sites within the study?
AE & SAE Incidence Indicator (in the OsRL Dashboard) in RAVEN
Can the study risk level change throughout the study life cycle? YES or NO? Provide rationale
Yes, it can but it's rare.
Usually, once the SRL is determined by the study team it will remain throughout the study. However, the study team may reassess SRL due to a protocol amendment, a change in study design. If there is a change, the monitoring plan will need to be updated as well.
Provide 2 examples of valid reasons you would see an override?
Multiple GCP violations, trending deviations/issues, site not following basic standards of conducting clinical research (ICH GCP), etc.
What determines the amount of SDV/SDR at a site?
Study and Site Risk Level and number of randomized subjects
True or False
The ongoing site risk level can only go one risk level up or down
False
The ongoing site risk level is not related to the previous risk level, it is independently calculated.
In what RAVEN dashboard can I review the number of important deviations and validity findings, assess any missing information and also review trends compared to other countries & study.
RAVEN COD Quality - DFF2
Clinical Overview Dashboard Quality - Deviations & Findings Frequency
How is the study risk level assessed?
A set of questions/risk statements based on the Transcelerate RACT (Risk Assessment and Categorization Tool)
(Refer to IRIS SP site-SRL guidance document)
Name at least three of your responsibilities as a CLM in reviewing the ongoing site risk leveling per site?
Review the OsRL in each monitoring event
Ensure proposed actions by the CRA are appropriate and effective per the risk level (yellow/red). Note that every red indicator does require a comment by the CRA
Review if override occurred and the override reason is selected and valid
Are FUIs or PDs documented as needed in IRIS
Review the OsRL in RAVEN for oversight for trends.
Over time, indicators should improve. If it doesn’t, is additional action needed?
Your CRA is concerned about not looking at all the data in the eCRF. Name at least 3 other functional reviews of data that are performed, besides the CRA's review.
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