Clinical Monitoring Services

  1. Investigator Identification, Selection and Recruitment

    2. Successful investigator selection and recruitment also includes site evaluation for space, clinical staff interviews, and equipment inspection. ClinDatrix will plan, prepare, conduct, and report on a Site Qualification Visit (pre-study screening visit) to ensure successful investigator selection.

  2. Site Qualification (pre-study screening visit)


  3. Key Personnel Training

    4. ClinDatrix will train key clinical site staff utilizing Investigator meetings, on-site personalized training, or office based teleconferencing or webcasts. In addition, ClinDatrix may use its proprietary electronic training system which can be web-accessed by clinical site personnel for their convenience.

  4. Planning Investigator Meetings

  5. Site Initiation Visit

    6. At the Site Initiation Visit, ClinDatrix CRAs will review the protocol and investigational brochure with the investigator and clinical site staff and provide detailed instructions for CRF completion. In addition, the CRA will review regulatory documents, discuss patient enrollment goals, review safety reporting, query handling, and drug and/or device management.

  6. Interim Monitoring Visit

    7. Throughout the course of the clinical investigation, the ClinDatrix CRA will monitor the site and perform the following: Informed Consent Form review, confirm HIPAA compliance, verify patient eligibility, perform source and CRF data review, retrieve clinical data (CRFs), monitor Adverse Event reporting, handle Query resolutions, reasons for screen failure or withdrawal, review regulatory documents, and perform drug and/or device accountability.

  7. Close-Out Visit – Study Termination

    8. ClinDatrix will finalize documentation at the clinical site in preparation for any pending audit by a regulatory agency (e.g. FDA). At the close-out visit the ClinDatrix CRA will perform final source documentation and CRF data review, reconcile regulatory documents, finalize Adverse Event documentation, patient disposition, and query resolution, and will retrieve the remaining completed CRFs and resolved Queries. The ClinDatrix CRA will also perform final drug and/or device, and study supply accountability and return. Finally, the ClinDatrix CRA will review with the site personnel, their obligations following study termination.

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