India Guidance Standardizes Adverse Event Reporting

India’s Drugs Controller General has released new industry guidance to combat formatting inconsistences and speed up processing for reports of serious adverse events (SAEs) in clinical trials. The draft guidelines, issued May 11 by the Central Drugs Standard Control Organization (CDSCO), aim to “achieve uniformity and completeness of data” in SAE reports. Pharmaceutical companies and contract research organizations (CROs) are currently submitting the reports in multiple formats, often with missing information, leading to difficulties in segregating and processing the reports, the guidance says.
Clinical Trials Advisor