Accelerator Program for Discovery in Brain Disorders using Stem Cells (ADBS)
There is emerging evidence that there are shared genetic, environmental and developmental risk factors in psychiatry, that cut across traditional diagnostic boundaries. With this background, the Discovery biology of neuropsychiatric syndromes (DBNS) proposes to recruit patients from five different syndromes (schizophrenia, bipolar disorder, obsessive compulsive disorder, Alzheimer’s dementia and substance use disorders), identify those with multiple affected relatives, and invite these families to participate in this study. The families will be assessed: 1) To compare neuro-endophenotype measures between patients, first degree relatives (FDR) and healthy controls., 2) To identify cellular phenotypes which differentiate the groups., 3) To examine the longitudinal course of neuroendophenotype measures., 4) To identify measures which correlate with outcome, and5) To create a unified digital database and biorepository.
CDSA is pleased to collaborate with NCBS, inStem and NIMHANS towards the successful completion of the study. Through the combination of project staffing and innovative project monitoring for the significant study, CDSA is selected provide the overall quality management to meet high standard of quality for the project.
|Study Site:||NIMHANS, Bangalore (participants enrolment); NCBS & inStem (Biorepository), Bangalore|
|Study Status:||Screened families 2499 , participants recruited 809 (as of April 2018)|
|Quality Management data review status:||•Overall Quality Management
•Risk Based monitoring strategy for Data monitoring and Process monitoring by identification of Critical Data Fields
•Quality management through online monitoring reports and tracking of each participant monitored
•Online resolution of monitoring queries
|Achievements:||• Concurrent monitoring of the enrolment data and processes
• Release of monitored data after query resolution on daily basis
• Escalation of critical quality issues to clinical team on weekly basis and their resolution
• Trend Identification and lessons learnt for prospective monitoring and data quality
- Dr. Siddhartha Roy with NIMHANS Team