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Clinical Monitoring

 

 

 

Pre-Study / Qualification Visit  
  CRI initiates a complete assessment of each clinical research site, capabilities of staff and evaluates the site's ability to adhere to FDA regulations, Good Clinical Practices (GCP's) and the overall conduct of clinical trials.  
Clinical Monitoring Initiation Visit  
  CRI provides full initiation of the clinical research site which includes but is not limited to, review of protocol, regulatory documents, Case Report Form, enrollment requirements, investigational drug and responsibilities for the conduct of the clinical trial.  
Interim Clinical Monitoring Visit  
  To ensure quality, CRI conducts ongoing clinical monitoring throughout the conduct of the clinical trial. Activities include: informed consent review, eligibility verification, Case Report Form and source documentation review, data retrieval, ongoing maintenance and review of regulatory documents, assessment of protocol adherence and drug accountability.  
Close-Out Visit  
  Upon completion of the clinical trial, CRI provides, final retrieval of all data, resolution of data clarification queries, assessment of regulatory documents, review of site regulatory obligations, investigational drug accountability and return.  

 

 

 

 

 

 

 

 

 

 

 

 

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