Services Provided by the CPOB Coordinating Center
The responsibilities of the CPOB Coordinating Center are organized according to phase of the clinical trial. The phases are categorized as initial design and protocol development, final preparation for trial initiation, patient recruitment, patient treatment and follow-up, patient closeout, and final termination of the trials.
Initial Design Phase and Protocol Development
During the initial design phase of a clinical trial, Coordinating Center plays a major role in the following activities:
- Developing the study design, including sample size calculations;
- Outlining the data collection schedule;
- Drafting chapters of the study’s Manual of Procedures;
- Outlining plans for data analysis;
- Outlining data processing procedures;
- Collaborating in the selection of clinical sites to participate in the trial
- Establishing collaborative arrangements with other resource centers such as image Reading Centers, central laboratories and investigational drug distribution centers
- Developing procedures to report serious adverse events;
- Outlining the data collection forms;
- Developing procedures for training and certifying staff at the clinical centers;
- Preparing other materials to be used by clinical center staff, such as patient logs and other auxiliary forms;
- Developing quality assurance procedures for all aspects of the study.
Final Preparation for the Initiation of the Trial
Prior to initiating a study, a number of activities are performed by the staff of the Coordinating Center to begin the trial with a fully developed protocol and well trained staff for all aspects of the trial. These activities include:
- Finalization of the protocol details;
- Drafting, pilot testing and finalizing the data collection forms
- Fine tuning the data collection and data management system to integrate all study activities;
- Development of computer systems to automatically generate appointment schedules and labels for data collection forms at the time of randomization;
- Completing beta testing of the adverse event reporting system and all other data systems;
- Training and certifying clinic coordinators, visual function examiners and study photographers at the clinical centers;
- Distributing a Manual of Procedures to all clinical centers;
- Supplying each clinical center with a set of study data collection form masters;
- Generating treatment allocation schedules for patients;
- Preparing and distributing minutes of meetings;
- Establishing a repository for study data and other documents;
- Ensuring that each clinical center has the required drugs, equipment and facilities;
- Meeting with the Data and Safety Monitoring Committee to review the protocol;
- Finalizing procedures for site visits to clinical centers;
- Collaborating with other resource centers to refine the editing of data collection forms;
- Collaborating with other resource centers to finalize the quality control program for image grading or laboratory assays;
- Drafting a study patient brochure, referring physician brochure, newsletter to clinical center staff, and standard slides for training and presentations to enhance recruitment.
Patient Recruitment and Treatment and Follow-up Phase
Activities during this phase can generally be categorized as administrative, data collection and processing, data analysis and reporting, quality assurance, and planning for future phases. Coordinating Center responsibilities are summarized for each category.
- Participating in the affairs of each of the standing committees;
- Providing the necessary logistical support for all study meetings;
- Coordinating communications among the various study centers and committees;
- Assisting the staff of each clinical center to interpret and follow the protocol and procedures documented in the Manual of Procedures;
- Supplying the clinical centers with new and revised data collection forms and other printed materials;
- Maintaining accurate study archives, including study history and proceedings of committee meetings;
- Issuing random assignments to treatment group;
- Preparing appointment schedules for the clinical centers to alert staff to dates on which clinic visits are expected;
- Preparing and distributing to clinical centers reminders of upcoming patient visits and materials overdue at the Coordinating Center;
- Publishing and distributing study newsletters for patients and clinical center staff;
- Developing and maintaining an information study website for study patients.
Data Collection and Processing
- Receiving data from the clinical centers;
- Entering the data into an electronic database (if paper forms);
- Storing the data for computer processing;
- Maintaining an inventory of all data received at the Coordinating Center;
- Editing the data for completeness, accuracy, and consistency and resolving questionable information with the Clinic Coordinators;
- Correcting data files in response to queries resolved by clinic staff.
Data Analysis and Reporting
- Preparing reports concerning the status of patient recruitment and follow-up, adherence to the protocol, quality of data collected, and clinic response to queries;
- Preparing periodic reports for the Data and Safety Monitoring Committee concerning adverse and beneficial treatment effects;
- Developing analytic methods appropriate to the study design, in conjunction with the Data and Safety Monitoring Committee;
- Preparing all analyses to be reported in publications from the study;
- Participating in the drafting of all study publications;
- Monitoring the accumulating data to determine whether the assumptions used to calculate sample size requirements are met and recommending modifications to the study design if these appear to be necessary;
- Reporting to appropriate audiences statistical and methodological innovations developed during the course of the study.
- Conducting initial training sessions for clinic personnel to review study design, data collection methods, and procedures for interfacing with the Coordinating Center;
- Regularly visiting each clinical center to review procedures and to "troubleshoot" in any area in which the clinical site may require it;
- Preparing monthly reports summarizing patient recruitment in each center,
- Preparing quarterly reports on adherence to protocol in the clinical centers;
- Maintaining documentation of all Coordinating Center procedures and operations;
- Maintaining the data files in a secure manner to assure their integrity;
- Backing up the data files to assure that data are not lost;
- Reporting on the quality of the data accumulated at the Coordinating Center,
- Reporting on the quality of data processing operations at the Coordinating Center.
- Planning for Future Phases
- Developing procedures for closing out patient follow-up at the appropriate time;
- Planning for permanent, accessible storage of study records and data.
Patient Closeout Phase
As with earlier phases, during the Patient Closeout phase the primary responsibilities of the Coordinating Center staff are concerned with coordination, developing, testing, and refining procedures, and data processing and analysis. Specific responsibilities during this period are:
- Familiarizing clinic staff with closeout procedures;
- Coordinating patient closeout;
- Monitoring adherence to established procedures for patient closeout;
- Developing plans for final data editing and storage;
- Completing plans for final analysis and preparation of publications;
- Developing plans for final disposition of the data files;
- Participating in paper writing activities;
- Providing a mechanism for continuing communications among investigators and performing additional analyses.
During the termination phase, the Coordinating Center performs the following functions:
- Completing scheduled data analyses;
- Placing data files and other materials in the selected archives;
- Distributing manuscripts and reprints of publications to the other investigators;
- Serving as the communications center.
For additional information, contact Ellen Peskin.