The Georgia Clinical Trianslational Science Alliance (GaCTSA) is offering Principal Investigators requiring Data and Safety Monitoring assitance the opportunity to request an in-person (Studio) consultation, or templates required for adherance of clinical trial monitoring, patient safety, and data integrity (e.g., Data and Safety Monitoring Plan, IRB Guidance Outline, DSMB Charter based upon NIH guidelines, etc.)
The Studio consultation offers a one-stop assessment of a proposed research project in order to outline a detailed plan of action for research success including identification of the necessary expertise for a successful project requiring Data and Safety Monitoring Board Guidance. A Studio Consultation will assist researchers in any of the following areas: Peparing for Clinical Trial for Data and Safety Board Monitoring, Guidance related to the Office of Compliance, Clinical Trials Audit and Compliance (CTAC), Institutional Review Board (IRB), Statitician: Data Collection, and Regulatory Assistance through the GaGTSA Coordinating Center.
The following questionnaire is needed to obtain additional details about your project. Upon receipt, the questionnaire will be reviewed to determine if the project is appropriate for a Studio Consultation and/or National Institute of Health (NIH) and Emory University IRB guided document. If the project is not deemed appropriate for a Studio Consultation, you will be provided with other resources or contacts to pursue. If the project is deemed appropriate for a Studio Consultation, we will move forward with scheduling the Studio Consultation.
Consultations are scheduled as needed and are based on the availability of all parties involved and the timeline of the proposal submission. Consultations usually last from 30 to 60 minutes. Duration will depend on the perceived needs of the researcher and of the proposal complexity.