PROVIDED that after submission and approval by the Central Licensing Authority, no c ...

Table of contents The table of contents may include the following information:— Centr ...

Monitoring plan General outline of the monitoring plan to be followed, including acce ...

Application for grant of permission to conduct clinical investigation (1) An applicat ...

Medical management and compensation related to clinical investigation (1) Where any ...

Device accountability Description of the procedures for the accountability of investi ...

For clinical investigations conducted in paediatric population, the reviewing Ethics ...

Maintenance of record Every person, sponsor, clinical research organisation, any othe ...