Clinical Monitoring

Concentrics has a team of very experienced clinical monitors that are located regionally in a variety of geographies.   These experienced monitors conduct key visits throughout the study:

Conduct Pre-Study Visits
Pre-Study Visits are conducted to assess the facility and the site team in terms of experience, capabilities and understanding of the protocol and its’ requirements for enrollment and successful completion. 

Conduct Site Study Initiation Visits
Site Initiation Visits (SIV) are conducted to re-assess the site and to provide a hands-on face-to-face training session for the team that will be conducting the study. 

Conduct Interim Monitoring Visits and Continuous Data Transfer for Cleaning
Concentrics will monitor each investigational site a pre-specified number of times during the course of the study and as deemed necessary by sponsor and Concentrics based on enrollment.  Monitoring reports and follow-up letters will be written after each monitoring visit.  All monitoring reports, plus follow-up letters, will be provided to the sponsor as designated.  The visit report templates will be approved by the sponsor prior to use.

During the interim monitoring visits, the monitors will review available CRFs and Data Correction Forms (DCFs), and will verify 100% of CRFs against source documents.  The monitors will review CRFs, DCFs, regulatory documents; any previously unreported AEs/SAEs, perform drug accountability, and meet with site personnel.

Since the CRF data will be submitted as the study progresses to allow for continuous data cleaning, an accounting of paperwork submitted to the data management will be part of the interim monitoring reports. 

Conduct Close-Out Visits
Concentrics will conduct close-out visits for all sites at the conclusion of the study to assure final collection of CRFs, DCFs and to return used and unused study medication supply to the sponsor.  During the close-out visits, the monitors will perform final review of regulatory documents, final drug accountability, and conduct a close-out meeting with site personnel. The close-out visit reports will be submitted to and reviewed by project management at Concentrics and forwarded to the sponsor.

Concentrics will ensure that the IRB is notified of the study close-out visit, and that IRB acknowledgement of the close-out visit is received from the IRB, and filed in the investigators regulatory binder as well as in the trial master file at Concentrics.


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