Serious Adverse Event

About SAE

The Drugs & Cosmetics Rules have been amended vide GSR no 53 (E) dated 30-01-2013 inserting a Rule 122DAB, and a new Appendix-XII in Schedule-Y along with other amendments. The amendments specify the detailed procedures for analysis of Serious Adverse Events (SAEs) including death occurring during clinical trial to arrive at the cause of death / injury to the subject, as the case may be, and to determine the quantum of compensation, if any to be paid by the sponsor or his representative whosoever have obtained permission from CDSCO.

As per Rule 122DAB(7), the Sponsor or his representative, whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial, shall provide financial compensation, if the injury or death has occurred because of any of the following reasons, namely-

Adverse effect of investigational product(s);
Any clinical trial procedures involved in the study;
Violation of the approved protocol, scientific misconduct or negligence by the Sponsor or his representative or the investigator;
Failure of investigational product to provide intended therapeutic effect (where, the standard care, though available, was not provided to the subject as per the clinical trial protocol),
Use of placebo in a placebo-controlled trial(where, the standard care, though available, was not provided to the subject as per the clinical trial protocol),
Adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol;
For injury to a child in–utero because of the participation of parent in clinical trial.

As per Schedule Y to Drugs & Cosmetics Rules, the Investigator, Sponsor and the Ethics Committee are required to report all serious adverse events of deaths as well as injury to the Licensing Authority in time bound manner.

Serious Adverse Event (SAE)

SAE is defined as an Adverse Event or Adverse Drug Reaction that is associated with death, inpatient hospitalisation (in case the study was being conducted on out-patients), prolongation of hospitalisation (in case the study was being conducted on in-patients), persistent or significant disability or incapacity, a congenital anomaly or birth defect, or is otherwise life threatening.

RULES GOVERNING SAEs:

122-DAB- Provision for examination of serious adverse event (SAE) of injury and death and payment of compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay compensation;

Schedule Y - Detailed guidelines and requirements for reporting and examination of SAEs.

Good Clinical Practice Guidelines issued by CDSCO, Directorate General of Health Services, Govt. of India

Functionalities

Processing of reports of SAE cases (i.e. Appendix-XI), review, approval for payment of compensation in cases of related cases as per Schedule Y, Rule 122 DAB under Drugs & Cosmetics Rules 1945)

Handling of Parliament questions and RTI queries related to SAEs.

Conduct of GCP Inspections based on the documents / information submitted for reporting of SAEs etc.

Review & action taken in respect to GCP inspection reports (Show-cause notice, response of show-cause notice, warning, debarment, suspension etc.)
Data-base management (receipts/files/other misc. data including Related and not related orders, maintenance of guard files, parliament questions answered etc.)