(PSH/CR/01-01, Version No. O1)
Clinical research should be carried-out in accordance with the ethical principles and confidentiality as described in applicable guidelines and regulatory requirement(s).
The rights, safety, and well–being of the clinical study subjects are the most important considerations and should prevail over interests of science and society.
Investigator is a person responsible for the conduct of the clinical study at the study site. If a study is conducted by a team of individuals at a study site, the investigator is the responsible leader of the team and may be called the principal investigator.
Clinical studies are experiments and we believe that to understand the diseases & to support development of new therapies, we should conduct clinical studies. All stakeholder should understand that the outcome of clinical research cannot always be predictable, hence, investigator & all supporting team members shall perform his / her duty sincerely and sensitively. The sponsor indemnifies the investigator / the institute against claims arising from the clinical study, except for claims that arise from malpractice and / or negligence.
Systems with procedures that assure the quality of every aspect of the clinical study should be implemented. Investigator is free from any commercial, financial and other pressures which might adversely affect the quality of his / her role for the clinical research.
The subject identity and the data are the confidential information and they shall not be accessible publicly, all involved stakeholder shall maintain the confidentiality. Sponsor of the clinical study holds the right to publish the part of the data analysis or complete results of the clinical study.
Safe and efficacious therapies are there in market, because we conduct clinical studies at all our hospital sites.
Authorized Signatory, Parul University