Monitoring

UCR provides monitoring support to ensure data quality, patient safety and compliance with applicable regulations in clinical studies.

Monitors act as a link between sponsors and study sites and are a key part of the study team. They work closely with participating sites to ensure that studies are conducted according to protocol and with high quality.

UCR provides monitoring support throughout the entire study lifecycle.

 

We also offer monitoring training

 

Monitoring steps

Before study start
Evaluation of sites and development of a monitoring plan, including review of study procedures and CRF/eCRF. Study start-up and initiation visits are prepared and conducted

During the study
Monitoring of active recruitment and follow-up phases. Monitors maintain close contact and collaborate with site staff, project managers, sponsors, data managers and statisticians

At study close-out
Monitoring activities at study or site closure, including clean file meetings and database lock preparation

Monitoring approaches

On-site monitoring
In-volves visits to study sites with access to source data and documentation

Remote monitoring
Includes review of databases and submitted documentation

Central monitoring
Provides a broader overview of data using statistical methods to identify trends and deviations, supporting risk-based monitoring

Contact

  • Phone UCR: 018-611 00 00 (UCR)
    Telephone exchange: 018-611 00 00
    (Akademiska sjukhuset)
    E-mail: info@ucr.uu.se

Visit us

Uppsala Clinical Research Center
Uppsala Science Park, Hubben
Dag Hammarskjölds väg 38
751 85 Uppsala

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