The study shall be performed in accordance with the applicable laws & regulations including observations of the esteemed Ethical Committee guidelines for the purpose of Bio-Medical Research on human subjects issued by the following authorities;
(i)Indian Council of Medical Research
(ii) Guidelines of Good Clinical Practices
(iii) Indian G C P guidelines
(iv)The principles laid down by the 18th World Medical Association(Helsinki,1964)
GBCRA shall ensure all procedures proposed to be defined in the Protocol issued by the respective Sponsoring Authorities are accordingly complied with and prepare Randomization lists, Character of the study, Content of Case Report Forms(CRF)/eCRF, and Discrepancy Resolution Forms(DRF)/Edrf
The Senior most and eminent Consultant Doctors attached to the GBCRA has got the profound knowledge for Recruitment of Patient after observing of all the normal procedure of obtaining the Scheduled Consent Form as per requirement stipulated under provisions of Indian Laws and Regulations vide (Article3.1)
The GBCRA has developed a unique system of documentation and dissemination of Information services in terms of the provisions of laws and regulations from time to time.
Kolkata, West Bengal, India.