The investigator, his/her staff and the sponsor’s project team must be trained selleck chem in (1) new regulations, (2) impact on the trial conduct, (3) the need for documentation and (4) regulatory compliance and inspections. During the clinical trial project training, the focus should be on[3](1) specific study expectations (2) procedures unique to the product or the study (3) regulatory requirements (4) human protection concerns and (5) critical importance of the informed consent process. It is essential for the investigator to understand and balance the need for quality and recruitment speed and aim for uniform quality standards for all clinical trials ?C investigator initiated, academic, local industry, global. This would require harmonization between research and practice and make documentation into effective vital practice for clinical trial conduct.

The sponsor has to invest a lot of time and effort in ensuring compliance to regulatory requirements and expectations. The monitors will have to conduct regular, frequent and long duration monitoring visits. It would also be essential to conduct regular audits at all the investigator sites during and after the completion of trial. The sponsor has a vital role in ensuring compliance and should have a predetermined strategy for obtaining compliance from the investigator.[4] The monitoring reports should be reviewed expeditiously, and immediate actions should be taken to correct noncompliance. The sponsor should terminate participation of sites in the study, in case of persistent and serious non-compliance.

The sponsor has to change from being accommodative to being assertive with the sites on compliance issues. AV-951 The new stringent and tough regulatory milieu requires an attitudinal shift, a paradigm shift from quantity to quality and from cost to compliance!
In recent years, there has been substantial debate about the ethics of research in developing countries. The quality of informed consent process is identified as one of the issues.[1] India’s clinical trials system has come under intense scrutiny selleck catalog after a series of scandals involving alleged malpractices which have sparked widespread public protests. Concerns have been raised about the lack of ethical oversight, and there have also been allegations that vulnerable patients are routinely recruited to clinical trials without proper informed consent. In a survey questionnaire served to 29 investigators in India, very few investigators (18%) felt that all their patients in studies were ??truly autonomous.??[1] It may be because of mainly cultural dependence on family, physicians, and community, irrespective of education.