General (i) Case Report Forms are established to implement the clinical investigatio ...

Cover page or login screen (1) Name of sponsor or sponsor logo. (2) Clinical investig ...

INFORMATION TO BE SUBMITTED ALONG WITH THE APPLICATION 1. Design Analysis data inclu ...

Definitions In these rules, unless the context otherwise requires, — (a) "academic cl ...

The information required under sub-rule (2) shall contain the following, namely:— (i ...

Short title and commencement (1) These rules may be called the Medical Devices Rules, ...

Types of Case Report Forms The following is a suggested list of CRFs that may be deve ...

PROVIDED that no fee shall be required to be paid by the institutes, organisation, h ...