The purpose of the Data Coordinating Center (DCC) for the Infant Aphakia Treatment Study (IATS) is to provide design and trial management support for this randomized multicenter clinical trial. In particular, the DCC will be responsible for the following activities: (1) Research Design: The DCC will provide statistical and epidemiological expertise in the design of the study. This includes defining outcomes, choosing the experimental design, estimating sample size and power, determining procedures to control bias, and evaluating the potential impact from any future proposed changes to the study design or procedures. (2) Case Report Forms: The DCC will collaborate with the clinical investigators to design the case report forms. The DCC will produce the case report forms and distribute the forms to the clinical centers. (3) Training: The DCC will train and certify clinical center personnel in non-clinical study procedures. (4) Patient Screening and Randomization: The DCC will design and implement patient screening and randomization procedures. (5) Data Management: The DCC will be responsible for all aspects of data management including data acquisition from the clinical centers, data editing for accuracy and completeness, monitoring completeness of follow-up and contacting centers to correct data problems. (6) Coordination with Visual Acuity Testing Center (VATC): The DCC will coordinate with the VATC on the collection and processing of the visual acuity data. (7) Clinical Center Monitoring: The DCC will conduct auditing visits to the clinical centers to verify the data submitted on CRFs and to check that the protocol is being followed. (8) Patient Tracking: The DCC will assist the clinical centers in tracking the location of patients. (9) Patient Adherence Monitoring: The DCC will place calls to the patients to monitor adherence to the patching protocols. (10) Adverse Event Monitoring: The DCC will monitor the occurrence of adverse events and will report to the Data Safety Monitoring Committee (DSMC) on a regular schedule. (11) Statistical Reporting and Analysis: The DCC will develop statistical reports for the DSMC and other agencies and will determine and carry out appropriate statistical analyses to evaluate study hypotheses.
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