Current perspective of severe adverse events and compensation requirements in India.
Article
in English
| IMSEAR
| ID: sea-157932
ABSTRACT
As per Drug Controller General of India (DCGI), there are clear cut compensation guidelines for clinical trial participants in case of death and injury after amendment in schedule Y (Rule 122DAB - Compensation in case of injury or death during clinical trial). The purpose of these guidelines is to provide Severe Adverse Event (SAE) compensation calculation as well as determination of the ratio of amount in clinical trial injury.
Full text:
Available
Index:
IMSEAR (South-East Asia)
Type of study:
Controlled clinical trial
/
Practice guideline
Language:
English
Year:
2014
Type:
Article
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