Mix Bag
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
What steps must the site do *before* registering a temperature-controled shipment in IRT?
1. Insert logger to print Libero PDF Report
2. Email PDF Report per instructions and wait for an Assessment
3. Print and file PDF Report and Assessment in ISF and call IRT
What is the difference between withdrawal of treatment (WoT) and withdrawal of consent (WoC)?
WoT: subject is doscontinued from IMP, but continues in the study for follow-up.
WoC: subject declines any further participation in the study and meet below criteria:
Subject is not willing to take study medications, does not want to come for any future visits, does not want to be contacted, and does not want to provide access to their health records.
Which visit reports require finalization within 10-business days?
SQV and SIV
What is the name of BI’s global repository of all pertinent clinical trial documentation (Essential Documents) as determined by ICH/GCP and BI requirements?
Trial Master File – TMF
Which type of visit does not include issues in its FUL?
SQV - these issues will be captured on the site selection letter.
Where do you order IMP return boxes?
Imperial Marketplace
Who is reponsible for submitting the SQV FUL to BIRDS?
The CRA
What visit report(s) requires detailed comments?
Site Qualification Visit (SQV)
How do you code your time when you meet with CTM/MRA/SMM to discuss an issue at a site?
Site Management
How do you document an update to an open issue?
Document the change in the action field with the date of the update. Do not delete the original action.
Name one of two important IMP deviations which the CRA should immediately in the CT Manager.
1. Expired medication was administered to trial subjects
2. Medication was incorrectly administrated to a trial subject
Who is responsible for ensuring site staff complete the protocol-required training before releasing IMP to the site?
CRA
For all visit type reports, what is expected in the visit details comment section of the report?
1. Remote or Onsite, 2. Actual days on-site for multi-day visits that are not sequential, 3. note if there is a deviation from the monitoring frequency, 4. Any BI personnel in attendance that is not in the system or more attendees than allowed in the system
Name two of the Clinergize CRA responsibilities.
1.Communicating the purpose and benefits of Clinergize during the SQV
2.Reviewing the TOC at the SIV and determining how the site plans to use Clinergize;
3.During SIV and throughout trial: explaining activities that the site staff is responsible for, including which kind of information and trial documents will be available and managed through Clinergize;
4. Notifying the CT Manager / MRA of staff who need Clinergize accounts; Providing help to the site; Reviewing Clinergize with sites; Being aware of trial updates distributed in Clinergize;
5. Verifying site document workflows are completed / acknowledged on an ongoing basis;
6.Reminding sites they will have to maintain and upload current versions of regulatory documents throughout the trial – they should work with their assigned SRC (RDR))
What are the 2 main types of issues that CRAs use?
Protocol Deviations and Administrative Actions
How are temperature excursion assessments during site storage (after confirmation of receipt) conducted?
Hint: It would be one of two ways depending on the trial/product
1. Storage Conditions for Trial Medication (STORM) process (STORM document exists)
2) Product Complaint (STORM document does not exist)
In BRAVE, where do you locate the list of Always Serious AEs and DILI?
Resources section of the Home Page in BRAVE
What 3 things are REQUIRED when you plan a visit in MySites?
Visit Start Date, Visit Type, CRA Name
How will a site get the SIV FUL?
via Clinergize
When would you log into IRT?
Prep for a visit; during a visit to reconcile IMP or return IMP; after a visit for FU if needed
How do CRAs check for accuracy and completeness of the storage, handling, dispensing and returning of medication at sites according to the CTP and TLMM? (Name 3)
1. Review completed Inventory Logs and Accountability Forms or documented in IRT
2. Review IRT documentation
3. Review temperature Logs and confirm the site is maintaining appropriate storage conditions
4. Confirm site has acted on any temperature excursions (reporting and quarantining as required)
5. Check that any IMP / AxMPs past their expiry date have been relabeled, if appropriate, or arrange return for destruction.
What is the deadline for submission of SMVs and SCVs?
5 week days from last day of visit and cut-off time is 5:59pm EST/ 2:59pm PST
When interacting with a site outside of the sequence for a pre-defined purpose, how is this documented?
Documented as correspondence (i.e., Site Contact)
Which reports would you run to view accurate details of outstanding site data including outstanding/overdue CRFs, missing signatures, missing verifications and all outstanding queries?
Run the BI Data Cleaning Report OR
360 Data Cleaning and 360 Query Management Reports