Clinical Monitoring ServicesAdequate Monitoring of Clinical Trials is imperative in assuring safe subjects, quality data and a well-executed study. For each phase of clinical monitoring, CRCI will provide to the client in a timely manner, a complete, detailed report after each completed clinical monitoring service.
|
 |
| |
Pre-Study / Qualification Visit |
| CRCI 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 |
| CRCI 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, CRCI 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, CRCI 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. |
|
 |
