Table 3 Composition, roles, and responsibilities of the research team coordinating and conducting the trial (Steering Committee), of the Auditing Committee and of the G-BIA (Gut-Brain Interaction in Autism) group
Research leading team/Steering Committee (see title page and author section for members) | Roles and Responsibilities |
|---|---|
• Principal Investigator (Trained research child psychiatrist) | Design and conduct of the trial, preparation of protocol and revisions preparation of investigators brochure (IB) and CRFs [case report forms], organizing steering committee meetings, recruitment coordination, clinical assessment coordination, EEG recording coordination, intervention coordination, adverse events monitoring, data collection and entry coordination, providing of annual and final reports to the ethics committee and mid-time and final report to the Italian Ministry of Health, publication of study reports. |
• Sub-Investigator (Trained research pharmaceutical chemical doctor) | Design and conduct of the trial, preparation of protocol and revisions, preparation of IB and CRFs, biochemical samples collection and analysis, biochemical measurement coordination, data collection and entry coordination, contacts with the company supplying probiotic and matched placebo and performing randomization and intervention assignment, coordination of statistical analysis, providing of annual and final reports to the ethics committee and mid-time and final report to the Italian Ministry of Health, publication of study reports. |
• Trained research Biomedical Engineer | EEG data processing, EEG statistical analysis Contribution to the development of the study design |
• Laboratory Technician | Biochemical measurement Contribution to the development of the study design |
• Trained research child psychologist | Clinical assessment and data collection and entry coordination Contribution to the development of the study design |
• Trained research child psychiatrist | Clinical assessment and data collection and entry coordination Contribution to the development of the study design |
• Trained research child psychiatrist | Managing of the unblinding of allocated concealed treatment to families by necessity (harms or serious adverse events) - Contribution to the development of the study design |
Auditing Committee (see title page and author section for members) | Roles and responsibilities |
• Steering committee • Senior trained research physicians | Reviewing progress of study trough periodic audits of all the relevant aspects of the clinical trial management |
G-BIA (Gut-Brain Interaction in Autism) group (see Acknowledgment section for members) | Selection of children from involved Neuropsychiatric Centers; collection of data |