As per regulation 29 of National Medicines (Clinical Trials) regulations 2145/2 of 19th October 2019, no amendments in the approved protocol of clinical trial can be made without seeking prior approval/notification from CTEC and relevant ERC.

Information to be supplied when submitting a protocol amendment;

i. An amended form as may be published in the NMRA web site should be completed.

ii. A Bold Heading should note that this is an Amendment and the date.

iii. Each amendment should be BOLD and in a BOX at the relevant position in the text.

iv. Summary of changes should be submitted in a tabulated format with the authorized signatures.

v. The amended supporting documents should be appended, including any new relevant publications.

The CTRD will review the application together with supporting documents and will referred to CTEC in its very next meeting for expert review if necessary and consideration for approval of the amendment(s)
(Refer details for processing of amendments – GL-027 Guideline for amendments to clinical trials)