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Adherence to a common protocol at every level of patient management and data collection is essential. The study data depends upon uniformity of observations and treatment techniques. The ultimate responsibility for seeing that each staff member is thoroughly familiar with the protocol and that care is taken to implement each aspect rests with the Principal Investigator in each unit. The Study Center Coordinator will serve as the key staff member at each Study Center and will be instrumental in assisting the PI in maintaining protocol adherence in all aspects of the study.
Problems that arise involving patients, personnel, space, equipment, interpretation of protocol, etc. will be given prompt attention through regular communication between the personnel in each Study Center and Study Headquarters.
7.2 TRAINING AND CERTIFICATION
The Study Center Coordinator should maintain an up-to-date copy of the Manual of Procedures and keep it in a convenient location. All problems related to protocol adherence should be brought promptly to the attention of the Principal Investigator and SCC and each individual should be notified of progress in solving problems related to protocol adherence. The initial training of the SCC will involve a detailed description of each individual's duties and responsibilities. These duties will include, but not be limited to, the following:
Study Center Coordinator will make daily visits to the NICU to develop positive interaction with the nursing staff, encourage patient recruitment, insure goggle compliance, monitor nursing care, field questions, and solve problems.
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The SCC will be responsible for insuring that all infants less than 1251 grams at his/her participating nursery unit(s) are logged in the LIGHT-ROP Admission Log. The SCC should make every effort to establish cooperative and effective relationships with nursery clerks and neonatology business personnel.
The SCC will keep the log updated daily during the week. Original Admission Log Forms should be kept together in an easily accessible, loose leaf binder or folder and arranged In chronologic order.
The SCC will have the first, and probably most extensive, contact with parents. This individual must have excellent interpersonal and communication skills. Adequate rapport must develop between parents and the SCC. This is absolutely essential to ensure enrollment and continued participation in and cooperation with the study. Parents will frequently turn to the SCC for clarification or confirmation concerning the rationale of the study. Therefore it is extremely important that the SCC be a mature, responsible person and have a thorough understanding of the protocol study design and reason for the study.
[Note : said SCC can sell parents on the no-draping rule only if s/he hides from them all the reasons why the authors say light can damage their eyes. Compliance depends on this deception.]
Ballard gestational age assessment will by performed by the participating center's neonatologist, SCC, or trained designee. Each SCC will obtain this information from the Nursery Admission Log.
The Informed Consent/Information Form will be given to the parents on initial contact. The SCC will be expected to learn and be knowledgeable about ROP and be completely informed as to the scientific basis and rationale for the LIGHT-ROP Study. The SCC and PI will be responsible for obtaining informed consent and guidelines and examples will be used to teach proper techniques in achieving this goal.
[Note : Why do they need special techniques for manipulating the parents into agreeing?]
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8.3 DATA AND SAFETY MONITORING COMMITTEE (DSMC)
The responsibility for reviewing the ethical conduct of the Study and for monitoring reports for evidence of adverse or beneficial treatment effects is assigned to the Data and Safety Monitoring Committee. Results of reviews will not be available to the participating investigators who are examing patients until the Data and Safety Monitoring Committee decides to release the resuits. Results of all data analyses will first be presented to the Data and Safety Monitoring Committee unless this committee gives other instructions.
Membership of the Data and Safety Monitoring Committee will include the following: one (1) neonatologists (unaffiliated with a participating study center); one (1) ophthalmologists (unaffiliated with a participating study center); two statisticians (unaffiliated with the Coordinating Center or the University of Texas); an ethicist, a neonatal nurse, and three (3) ex officio members (the Study Chairman, the Principal Investigator of the Coordinating Center, and a representative from the National Eye Institute.) The DSMC chair will be appointed by mutual aggreement with the Study Chair, the Principal Investigator at the Coordinating Center and officials at NEI. Members of the DSMC are expected to acquire and maintain familiarity with study details.
The Data and Safety Monitoring Committee will review the initial design of the study, including patient recruitment methods and the informed consent procedures and related forms, and will provide approval before investigational procedures are carried out. The Data and Safety Monitoring Committee will be informed of all changes in the protocol. The DSMC will make recommendations to the Study Chairman on the ethical aspects, with particular attention to the rights and welfare of human subjects. The DSMC will be informed of ancillary studies approved by the Executive Committee. The DSMC will review periodic reports prepared by the Coordinating Center on the progress of the study, such as patient enrollment, adherence to the Manual of Procedures, and completeness
The Data and Safety Monitoring Committee (DSMC) will review the study results and evaluate the treatment for beneficial and adverse effects twice a year. The Data Monitoring Reports, distributed by the Coordinating Center, will be reviewed only by the DSMC until such time as the data indicates that a change of protocol may be required. These reports will be kept confidential and will not be made available to other study participants until such time as a decision is made to either terminate the study or to change the treatment protocol because beneficial or adverse effects of the study treatments have become evident. (Even though trends may not be significant, knowledge of interim trends in the data by study participants who are treating study patients may suggest to these participants that one of the study treatments is more beneficial or harmful than the others and such a suggestion could prejudicially influence a participant's enrollment, treatment or follow-up of the study patients.)
On all operational aspects of the study the DSMC will communicate to the study Chairman and Executive committee through the routine review of the progress of the study. They will also advise the National Eye Institute on policy matters affecting the progress of the study and on the future courses of action that might result from the LIGHT-ROP feasibility study.
Recommendations for protocol change will be based on the majority opinion of the DSMC. Each member of the DSMC will have a vote in all decisions. A minority opinion may be prepared at the discretion of the dissenting members of the committee. Decisions made by this committee relating to protection of patient rights and/or resulting from data analyses will be forwarded to the Executive Committee for implementation. The Executive Committee may appeal such decisions by sending a dissent statement back to the DSMC for reconsideration. The second opinion by the DSMC will be referred to Dr. Kupfer at NEI for resolution if a major change is recommended e.g. terminating the study.
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The Chair of the DSMC will convene this group before any Infants are enrolled and will, at least twice a year, reconvene this group to review the special Data MonitorIng Reports prepared by the Coordinating Center. Any member of the Committee may request a meeting if he/she feels the data In an Interim report warrant such a meeting.
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