Study Start-up
Functional Plan the L-MCRA is responsible for.
What is the Monitoring Plan?
Minimal meeting occurrence for the Study Compliance Meeting (SCM)
What is quarterly?
This is the best way to keep the monitoring team up-to-date on the study.
What is Communication (study updates, monitoring visit compliance, supplemental ad-hoc meetings)?
This guideline assists both the MCRA and LMCRA in the proper way to report compliance problems.
This assessment is required prior to Trial Design Review Board (TDRB)
What is the Initial Risk Assessment tab of the Risk Assessment Categorization Tool (RACT)?
This dashboard is used for the study compliance meeting.
What is the Global Study Compliance Dashboard in Tableau?
This report is requested to be compiled quarterly to out-of compliance monitoring visits.
What is the BUMR (Business Unit Metrics Report)?
This system is used to document Issue Escalations (and triggers/actions as a result of the Study Compliance Meeting).
What is CLARITY?
2 L-MCRA responsibilities during Site Selection Process
what are: Provide input to Site Selection Questionnaire; Obtain Site List, Collect monitoring input, review past site performance; recommend SQV type, support M-CRA; may vote; notify Reference Manager to assign sites (resourcing)
This document is the output of the Study Compliance Meeting.
What is meeting minutes?
Two of the four types of audits in which the L-MCRA may assist.
What are CQA Site Audits, CQA Sponsor Audits, Regulatory Authority Sponsor Inspections, or Regulatory Authority Site Inspections?
This is the first step in the Issue Escalation Process (following communication to the LMCRA).
What is document in CLARITY?
This plan includes Critical data and Key Risk Indicators (KRIs)
What is the Integrated Quality Risk Management Plan (IQRMP)?
2 of the activities to be done following the SCM
what are: Communicates to M-CRA any issues requiring action; Distribute minutes; Document in Clarity; upload to WindChill?
This meeting is conducted as part of the Work Instructions, 92295485, at a minimum frequency of quarterly.
What is the Study Compliance Meeting?
Per Work Instructions, 92295485, this formal communication to the site can be used to secure compliance.
What is an Investigational Site Corrective and Preventive Action (IS-CAPA)?
It is important for the L-MCRA to provide input on this primary document to mitigate potential PDs, clarify site staff training expectations, eligibility criteria, and source documents to be collected.
What is the protocol or Clinical Investigational Plan (CIP)
This document contains the storage location of the meeting minutes (and all other study documents)
What is the Study Master File Index (SMFI)
This is the functional owner of the Closeout Process.
What is the CTM/CPM?
This system is used to document IS-CAPAs.
What is Veeva?