Clinical Trial Application (CTA) submission in India

A Clinical Trial Application (CTA) is submitted to regulatory authority (Drugs Controller General of India) to seek approval for conduct of a clinical trial in India. Form 44 is an application made for grant of permission to import or manufacture a new drug or to undertake Clinical Trial. The trial sponsor has to submit the application (Form 44) and documents pertaining to chemical and pharmaceutical information, animal pharmacology, toxicology data and clinical pharmacology data. Other trial-related documents that must be submitted for approval include the Investigator’s Brochure, trial protocol, case report form, informed consent form, patient information sheet, investigator’s undertaking and IEC approvals (if obtained  during review process).
Continue reading Clinical Trial Application (CTA) submission in India

Importance of documentation in Clinical Study or Scientific Research

Documentation serves as a backbone for successful conduct of a clinical study or  scientific research. A trail can be effectively generated only through proper maintenance of documents. Clinical study or Scientific research documentation entails an array of documents which are completed by different people at several stages of the study. Nevertheless the documentation at the investigator site is the most crucial since study results are based on credible and valid data. Therefore emphasis is generally laid on continuous training of the sites to ensure that the investigator and team understand the requirements of good documentation. The principles of good documentation practice recommend to document what was done and what was not done.
Continue reading Importance of documentation in Clinical Study or Scientific Research