S/he has to be responsible for coordinating with the EC and sponsor the process of medical management and compensation. The investigator also needs to ensure that the site has adequate selleck screening library infrastructure, equipment, well-trained team and ready documentation to face regulatory inspection. Hence, there will be a tremendous increase in site burden-time and effort-in recruiting and managing clinical trial patients. INCREASE IN COST The site cost per patient will increase, as the investigator has to spend more time per recruited patient. The investigator has to devote time and effort to become aware of new regulatory compliance processes, to supervise and train staff in regulatory compliance and inspection readiness. She/he also has to be available for frequent and long monitoring and audit visits from the sponsor team.

The EC has to oversee the trial, and to review and comment on causality and compensation for SAE, document the EC discussions and decisions diligently and maintain records and be ready for regulatory inspections. This will mean an increase in the number and duration of EC meetings, and additional work for the EC members and support staff. This could result in increase in EC fees. For the sponsor, in addition to the above, the cost of medical management, compensation for clinical trial related SAE, and exhaustive monitoring and audit will have a big impact on the trial budget. However, the major question is: will these speed and cost changes improve the quality of clinical trial conduct? ENSURING QUALITY AND COMPLIANCE The regulatory inspections conducted to check good clinical practice (GCP) compliance have highlighted areas of deficiencies in quality.

Of the US Food and Drug Administration (FDA) inspections at 43 Indian sites, the finding was voluntary action indicated for 18 (42%) sites.[3] The inspection findings Dacomitinib have been: (a) failure to follow investigational plan (b) inadequate and inaccurate records (c) failure to obtain and/or document subject consent (d) failure to notify Institutional Review Boards (IRB) of changes, failure to submit progress reports and (e) inadequate drug accountability. The CDSCO’s for-cause inspections have revealed compliance deficiencies in ethics approval, consent, and safety reporting.[2] These regulatory inspection findings suggest that there are deficiencies in compliance to regulatory requirements for (1) human protection and (2) data integrity. The challenge of meeting regulatory expectations ref 1 of compliance and ensuring quality would require a change in mindset of all the stakeholders. Post 2013, the EC’s role has become crucial in ensuring rights, safety and well being of the clinical trial participants.