CCCRI Services
MONITORING
A dedicated clinical team of highly skilled CRA professionals provide consistent and effective monitoring and interaction with study sites. To ensure seamless communications with your organization, a single project manager serves as your contact for all aspects of your study.
Clinical Research Associates (CRAs)
CCCRI works to retain top-notch CRAs. While working with CCCRI, CRAs are required to uphold the following standards:
- be fully insured
- reside within the same region of the site
- must demonstrate site monitoring proficiency to management before being allocated to a study
For international projects, CRAs are assigned to monitor sites in their home countries, providing understanding of local languages, regulations, customs and business practices
CCCRI monitors will perform all Initiation, Routine Monitoring and Close-Out Visits per current Standard Operating Procedures and FDA regulations set forth in 21 CRF parts 50, 54, 56 and 312.
The following is a summary of the tasks to be completed at each visit:
Initiation Visits:
Each site will be visited once prior to enrolling patients to complete an initiation visit. The following tasks will be completed:
- Review of investigational status of the drug.
- Review of the protocol with the Primary Investigator, Clinical Coordinator,
- Pharmacist and other members of the clinical staff as appropriate.
- All Sponsor and Primary Investigator responsibilities as outlined in 21 CFR Part 312.
- Review obligation of Primary Investigator to obtain written consent in compliance with 21 CFR Part 50.
- Review obligations of Primary Investigator to obtain IRB approval and to assure that the IRB are in compliance with 21 CFR Part 56.
- Review all study documentation, including the site's regulatory binder, documentation of serious adverse events, drug accountability forms and CRF's.
Periodic Routine Monitoring Reports:
Each site will be visited at regular time periods throughout the course of the study to ensure:
- The Primary Investigator is following the protocol and clinical plan as appropriate.
- The facilities remain adequate for the trial.
- The study staff remains adequate throughout the course of the trial.
- Changes to the protocol have been IRB approved.
- The site is keeping accurate and complete records, including patient medical and drug accountability records.
- The Primary Investigator continues to carry out the protocol required procedures, without delegating them to previously unidentified staff.
- The case report forms (CRF's) and corresponding source documents are complete, accurate and legible.
- Informed consent has been documented for each patient.
Final Close-Out Visit:
A representative of Cape Cod Clinical Research, Inc. will visit each site, at the end of the trial; Inc will visit each location to perform a Final Close-Out Visit. Tasks to be completed at this time include (but are not limited to):
- Assuring that all clinical data has been retrieved, and all quires have been completed.
- Review of all regulatory documentation to assure its completeness.
- Assuring that the site's regulatory files are consistent with the master files.
- Review all investigational medication accountability, and assure that all study supplies have been returned or destroyed.
- Review the current record retention guidelines set forth in 21 CRF Part 312.
- Assuring that the Primary Investigator has provided the IRB with a final report.
- All site visits will be performed in compliance with the FDA's "Guideline for the Monitoring of Clinical Investigations."
CCCRI will be happy to further discuss your specific monitoring service needs and thus develop a detailed project scope.
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