Services

The CCCT has a 25-year history of successfully coordinating large cardiovascular and pediatric ophthalmology multicenter clinical trials and providing comprehensive services for these trials. The following are some of these services:

Developing Protocols, Forms, and Manuals of Operations

Work with sponsors and the steering committees to development study protocols, study forms, and a detailed manuals of operations (MOO). top

Designing Web-Based Randomization

Design and implement web-based systems for randomization and data collection that are available to all clinical sites on a 24-hour, 7-days-a-week basis with appropriate security feedback, monitoring, and backup to ensure all randomized participants are protocol eligible. top

Implementing Trial Management and Data Gathering Systems

Implement and insure a high quality, standardized, data gathering and trial management system for collecting all study data, monitoring study progress, providing feedback to participating components, and assessing study outcomes. The CCCT employs secure web-based data entry systems that include all data collection forms and that allows study investigators to access their respective clinic’s study data and performance history. top

Providing Training

Provides training on recruiting, enrollment and randomization; clinical and laboratory procedures; and Web based data collection, entry, and transmission. Certification and continuing education credits are provided when appropriate. top

Selecting Sites

Select sites so as to maximize patient safety, ensure high quality patient care, reflect the current practices of experienced medical practitioners, and provide a consistent clinical environment. top

Monitoring Recruitment and Providing Recruitment Resources

Monitor patient recruitment by providing weekly reports to the clinical sites, the sponsor, core laboratories, reading centers, and the drug distribution center during the recruitment phases, and maintain updated reports on a secure web site accessible to all units of the study. Serve as a central resource to maintain high recruitment and participation rates by providing recruitment aids (video, posters, cards, etc.), participant and clinic newsletters, and study-wide suggestions. Maintain newsletters and other study training, recruitment, and adherence aids on study web sites where they are accessible to appropriate study components. top

Conducting Reviews and Evaluations

Conduct timely reviews and evaluations of all clinical outcome events in a uniform fashion, and provide case and summary reports to the sponsor and the Data Safety and Monitoring Board. top

Monitoring Adverse Effects and Events

Implement a scheme for timely monitoring of adverse effects and trial events to insure patient safety, including notification and reports to the sponsor, the Data Safety and Monitoring Board, and to other appropriate agencies according to regulatory requirements. Provide an Adverse Effect and Event Report form on the trial’s secure web site that can be completed and filed online or that can be printed and faxed. top

Maintaining Data Bases and Analyzing Data

Maintain the study data base, including documentation of variables and collection procedures, and insure appropriate confidentiality and security of these files. Analyze and present data collected during the course of the study to the sponsor, steering committee, Data Safety and Monitoring Board, and subcommittees. top

Assuring Quality Control

Maintain quality control at, and monitor the performance status of, the clinical centers and the core laboratories and other central units. Make available performance and quality control reports on a secure web site. top

Establishing Core Laboratories

Solicit, select, and oversee the core laboratories and other central units. top

Recruiting Investigators and Centers

Experienced at recruiting and selecting contract clinical investigators and clinical centers qualified to enroll, treat, and follow a defined study population sample and willing and able to adhere to a randomized clinical trial protocol and follow its procedures. top

Coordinating Steering Committees and Data Safety and Monitoring Boards

Coordinate, arrange, participate in, and provide any information necessary for regular steering committee meetings and prepare and distribute minutes of each meeting and any other correspondence necessary within one to two weeks following the meeting. Maintain meeting schedules, agendas, and minutes on a secure web site accessible to all units of the study. Assume responsibility for arranging and conducting regular Data Safety and Monitoring Board meetings, conference calls, and meetings. top

Providing Annual and Interim Reports

Provide an annual report that will include issues not covered by the reports otherwise generated during the year. Provide a report, summarizing performance of recruitment and follow up during the pilot phase by the date agreed upon during protocol development. The report will contain sufficient detail to allow the Data Safety and Monitoring Board and the sponsor to make a fully informed decision about whether to proceed with the main trial. top

Collecting Final Data and Producing Final Data Sets and Final Reports

Implement a plan for final data collection from all clinical centers, core laboratories, and other central units. Provide a final study data file or data set according to the technical format specified by the sponsor with detailed documentation. Provide a final report that documents and summarizes the results of the entire study, including recommendations and conclusions based on the experience and results obtained. top

Overseeing Regulatory Compliance

Serve as a central resource for Institutional Review Board (IRB) approval and oversee regulatory compliance at all trial clinical sites, including those practices without local IRB affiliation. Monitor adverse effects of therapies. This includes reporting clinical data to regulatory agencies and clinical alerts to clinical investigators in a timely fashion. Ascertain and validate the cause of participant deaths and hospitalizations. Ensure and monitor the acquisition of informed consent from all patients prior to enrollment and throughout the trial in the event of protocol changes or ancillary studies. Provide instruction on ethical treatment of human subjects and scientific integrity. top

Monitoring Vital Status

Monitor the vital status of all randomized patients and act immediately on any participants considered lost to follow up by the clinical staff. Assist local sites with additional steps to locate dropouts and initiate external searches for confirmed lost. Conduct ongoing and periodic external surveillance by submitting patient rosters to public agencies including the National Death Index (NDI), Social Security Administration, and Health Care Finance Administration (HCFA) in order to monitor vital status and morbid events through Medicare hospitalization records. top

Disseminating Study Information

Develop and execute plans for dissemination of trial results to professional groups, medical schools, the medical community, and the public. Target leaders in appropriate specialty practices and develop guidelines. Analyze data and assist in preparing papers and presentations as needed for study publications and presentations at scientific and professional society meetings. top

Altering Study Methodology as Required

Develop and implement new statistical and clinical trial methods as needed to address issues that may arise. top