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Monitoring.
The Clinical Research Associate (CRA/Monitor) is at the core of
any CRO’s activities. Most ERGOMED CRAs are MDs, PhDs or
have other medical-related backgrounds; their experience and training
ensure the highest clinical research standards.
Responsibilities of ERGOMED CRAs include:
• Ensuring that Informed Consent has been signed by all
patients recruited
• Performing Source Data Verification (SDV) on the CRFs.
• Monitoring drug accountability and authorising drug returns
• Ensuring that the site documentation is complete and accurate in the
site file
• Ensuring that sufficient study materials are in stock at all times
• Reviewing, reporting and discussing patient recruitment progress and
any recruitment issues with on-site personnel
• Visiting the laboratory and the pharmacy as appropriate
• Transferring completed CRFs to the relevant Data Management function
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