A standard operating procedure is a set of instructions having the force of directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. Standard Operating Policies and Procedures can be effective catalysts to drive performance improvement and improving organizational results.
This standard operating procedure (SOP) describes the policy and procedure in the performance of the study review portion of the investigator regulatory files. It is required that all principal investigators maintain complete regulatory documentation since these documents permit evaluation by the proper regulatory authorities for the conduct of the research study as well as the quality of the data produced. The regulatory documents serve to demonstrate compliance of the investigatory and/or sponsor with the standards of Good Clinical Practice (GCP) and other applicable requirementsThe Office of Human Research Protection (OHRP) strongly recommends that all supportive study documentation for individual studies be maintained in an easily accessible and organized file systemsuch as a three-ringed binder labeled with the appropriate tabs
The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.
In 1911, the Government of India set up the Indian Research Fund Association (IRFA) with the specific objective of sponsoring and coordinating medical research in the country. After independence, several important changes were made in the organisation and the activities of the IRFA. It was redesignated the Indian Council of Medical Research (ICMR) in 1949, with considerably expanded scope of functions. The ICMR is funded by the Government of India through the Ministry of Health & Family Welfare
A.Company Protocol/Protocol B. Investigational Drug Brochure C. Amendments D. IRB Submission E. VA Submission (if required) F. IRB Correspondence G. IRB Approval H. Annual IRB Re-approval for Phase III studies I. Company Correspondence
N. Clinical Study Agreement (Investigator's Agreement)
R. Laboratory Reference Range and Certification
CDSCO- Regulatory Status The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General (India) (DCGI) discharges the functions allocated to Central Government. The CDSCO is attached to the office of the Director General of Health Services in the Ministry of Health and Family Welfare. The DCGI is a statutory authority under the Act and has port offices, zonal offices with drug inspectors and drug testing laboratories functioning under him. The CDSCO is the authority, which lays down rules, standards and approves import and manufacturing of drugs, diagnostics, devices, and cosmetics. Currently, CDSCO’s functions are to establish the standards and regulations for drugs, blood and blood products, intravenous fluids, and vaccines. With added responsibility of regulating the medical devices industry, CDSCO will be the approving authority for import, manufacture and sale of medical devices in India. The regulatory procedure will be clear only after the government notifies the regulations and the CDSCO provides the import guidelines. But as we understand it, subsequent to the government’s notification, foreign and India companies will have to apply for permission to import, and sell medical devices in India.