Methodology

A team of experts from aarth-India shall be contributing to effective management of clinical trials. On a 6-monthly basis an update report with a done-and-to-do list will be forwarded to the RTIICS authority. Major part of the responsibilities shall be executed on line and on a distant implementation mode. However the Project Advisor shall, for a face-to-face dialogue at the hospital’s premises/office, as far as practicable, make himself/herself available as and when necessary, up to a maximum of 2 visits per month.

This consultancy service project would hopefully be able

• To instill confidence in the investigators, ethics committee members and site managers at RTIICS towards conduct of clinical trials
• To assure that the rights, well being and dignity of the trial subjects are not compromised
• To ensure more efficient conduct and management of clinical trials at RTIICS. Continuous training and capacity building sessions are essential for investigators and ethics committee members. This project would continuously assess the need for training and education. But imparting training and holding learning sessions will not be covered under this project. The aarth-India can take up separate assignment for such responsibilities.