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SR NO
Name
FileName
1
Registration of Clinical Trials ( 26 Jul 2012 )
CTRegistration.doc
2
Guidance on Clinical Trial Inspection ( 26 Jul 2012 )
CT Inspection -11-2-2011.pdf
GCP inspection Checklist NEW
Formula to Determine the quantum of compensation in the cases of Clinical Trial related serious Adverse Events(SAEs) of Injury other than Deaths Occuring During Clinical Trials
PROPOSAL FOR CREATION OF IT ENABLED SYSTEM
Formula to Determine the quantum of compensation in the cases of Clinical Trial related serious Adverse Events(SAEs) of Deaths Occuring During Clinical Trials
Draft Guidelines on Audio-Visual Recording of Informed Consent Process In Clinical Trial
Audio -Video Recording of Informed Consent Process of All New Subjects in Clinical Trials- Administrative Orders
Monitoring of Clinical Trials - regarding
Details of Global Clinical trial approved in 2012
Advisory notice on clinical trial
Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices
Office Order: Submission of Periodic Safety Update Reports (PSURs)
New Drugs Recommended by NDAC for marketing authorization in India without Local Clinical Trial (Till August 2012)
Good Clinical Practice Guidelines
Draft Guidance For Industry On Requirement Of Chemical & Pharmaceutical Information Including Stability Study Data Before Approval Of Clinical Trials / BE Studies
DCG(I) approved Clinical Trial registered in Clinical Trial Jan 2013
System of Pre-screening for submission of reports of SAEs to CDSCO
System for the Pre - Screening of the applications for registration of Ethics Committee
Panel of Experts for examination of reports of Serious Adverse Events (SAEs) of Deaths