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Department of Biotechnology
Ministry of Science & Technology
Government of India
Informed Consent Documents (ICD) consisting of Patient Information Sheet and Informed Consent Form/ Assent Form in clinical research are becoming increasingly long, complex and sometimes in a language that is not well understood by the layperson. To make the technical term simpler with a low level of reading difficulty, Clinical Development Services Agency (CDSA) is developing a glossary of medical terms that are further simplified in simple English (and future in regional languages) for the benefit of the researchers. The glossary has been developed based on the published medical glossary, guidelines and our current understanding. The glossary is not intended to be a dictionary, rather, it contains words and phrases which translate complex medical terms into simple English words suitable for use in ICD. A number of alternative explanations or descriptions are provided throughout the glossary. These alternatives are interchangeable and you can select whichever you feel is most appropriate.
The terms in the glossary have not been tested with layperson, please test to ensure the document in its entirety is easy to use and understandable. The document does not establish any rights for any person and is not binding on CDSA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. In no event shall the CDSA or the authors of the original document be liable for any claim, damages or other liability arising from the use of this document. Suggestions are invited from the public. If you have any suggestions or simpler term(s) for complex medical English term, please send them to firstname.lastname@example.org and we will include them in the list, if it seems appropriate.