Our Integrated Approach

MCRA will work with the sponsor to draft the Clinical Monitoring Plan at the study outset. In order to provide the most accurate study management, MCRA will work with the sponsor to update the Monitoring Plan throughout the study and can either increase or decrease the frequency of planned visits to sites based on factors such as patient enrollment, data entry and query resolution trends, site training needs, and observed site issues. 

Per the agreed upon Monitoring Plan, MCRA's Clinical Research Associates (CRA) conduct Site Initiation Visits (SIV) at each of the participating sites once all of the essential documents have been collected and investigational product has been shipped to the sites. At each SIV, MCRA will train the site staff on the protocol, CRFs, Good Clinical Practice (GCP) guidelines, study logistics, use of the EDC system and expectations during future monitoring visits. 

At Interim Monitoring Visits (IMVs) the CRA will ensure:

  • Written informed consent is obtained prior to each subject's participation in the trial
  • Data entry is current and accurate, and discrepancies are resolved in a timely manner
  • Required reports, records and regulatory or essential documents are filed on site and with the sponsor
  • New information is provided to the sites and patients in a timely manner

Each Interim Monitoring Visit (IMV) will last an average of one to two days. IMV durations can be modified by the sponsor based on the number and speed of patients that have been enrolled, reported Adverse Events and Protocol Deviations, staff changes at the site, and the site's overall performance.

During the close out visits, MCRA monitors resolve all outstanding data queries, complete device accountability, follow up on any Adverse Events, perform a final review of the Trial Master File, reconcile regulatory logs, and remind the Investigator of their ongoing obligations once the study ends.

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Abigail Allen

Abigail Allen

Senior Director, Clinical Affairs