
CDSCO Guidance on Good Clinical Practices: Sponsors’ Responsibilities
The new article provides extensive clarifications regarding the responsibilities of study sponsors as the parties playing the key role in the investigation process.
The new article provides extensive clarifications regarding the responsibilities of study sponsors as the parties playing the key role in the investigation process.
The new article outlines the key points regarding patient preference information and its use in the context of the product lifecycle.
The new article outlines the key responsibilities of an investigator in the context of a clinical trial.
The new article addresses the matters related to monitoring to be conducted in the course of a clinical investigation.
The new article goes into further detail regarding the record-keeping requirements, as well as quality assurance in the context of clinical investigations intended to be conducted in India.