Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Clinical Trial

S.no Title Release Date Download Pdf Pdf Size
1 GCP Inspection Checklist16 2018-Feb-09 261kb
S.no Title Release Date Download Pdf Pdf Size
1 Submission of PSUR 2018-Feb-09 529kb
2 System of Pre-screening for submission of reports of SAEs to CDSCO 2017-Feb-17 255 KB
3 Draft Guidance For Industry On Requirement Of Chemical & Pharmaceutical Information Including Stability Study Data Before Approval Of Clinical Trials / BE Studies 2017-Feb-17 2599 KB
4 Formula to Determine the quantum of compensation in the cases of Clinical Trial related serious Adverse Events(SAEs) of Deaths Occuring During Clinical Trials 2017-Feb-17 310 KB
5 Panel of Experts for examination of reports of Serious Adverse Events (SAEs) of Deaths 2017-Feb-17 667 KB
6 System for the Pre - Screening of the applications for registration of Ethics Committee 2017-Feb-17 206 KB
7 Monitoring of Clinical Trials - regarding 2017-Feb-17 397 KB
8 GCP inspection Checklist 2017-Feb-17 261 KB
9 Good Clinical Practice Guidelines 2017-Feb-17 1074 KB
10 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 2014-Feb-17 368 KB
11 Draft Guidelines on Audio-Visual Recording of Informed Consent Process In Clinical Trial 2014-Feb-17 434 KB
12 DCG(I) approved Clinical Trial registered in Clinical Trial Jan 2013 2013-Feb-17 99 KB
13 Registration of Clinical Trials ( 26 Jul 2012 ) 2012-Feb-17 369 KB
14 New Drugs Recommended by NDAC for marketing authorization in India without Local Clinical Trial (Till August 2012) 2012-Feb-17 166 KB
15 Guidance on Clinical Trial Inspection ( 26 Jul 2012 ) 2012-Feb-17 492 KB
16 Details of Global Clinical trial approved in 2012 2012-Feb-17 926 KB
S.no Title Release Date Download Pdf Pdf Size
1 Notice regarding conduct on clinicl trial in present situation due to outbrea of COVID-19 2020-Mar-30 602 KB
2 List of approved Clinical Trial Sites and Investigators 2019-Dec-02 1932 KB
3 List of approved Clinical Trial Sites & Investigators for Global Clinical Trials 2019-Dec-02 347 KB
4 Notice regarding human vacine appliation through SUGAM online Portal of CDSCO 2017-Dec-26 584KB
5 Notice Order regarding SUGAM ONLINE Dated 01.12.2016 2016-Nov-01 260KB
6 Notice Order regarding SUGAM ONLINE 2016-Oct-05 259KB
7 Notice for Online Clinical Trial Application and Monitoring System (OCTAMS) 2015-Sep-09 52KB
8 Office Order dated 05.09.2014 reg. Information required in respect of Conduct of the Clinical Trial of New Drugs and GCT in India 2014-Sep-05 503KB
9 Notice 28.07.2014 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Jul-28 210KB
10 Office Order dated 03.07.2014 - Waiver of CT in Indian Population for approval of New Drugs 2014-Jul-03 152KB
11 Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time 2014-Jul-03 158KB
12 Office Order dated 03.07.2014 - Number of subjects in Phase III Global CT 2014-Jul-03 151KB
13 Office Order dated 03.07.2014 - Placebo Controlled Trials 2014-Jul-03 174KB
14 Office Order dated 03.07.2014 - Providing Ancillary Care to the Clinical Trial subjects 2014-Jul-03 156KB
15 Office Order dated 03.07.2014 - Approval of academic CT 2014-Jul-03 146KB
16 Office Order dated 03.07.2014 - Clinical Trial on Medical Device 2014-Jul-03 164KB
17 Office Order dated 03.07.2014 - CT Compensation in case of injury or death discerned at a later stage 2014-Jul-03 164KB
18 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Feb-17 211 KB
19 Audio -Video Recording of Informed Consent Process of All New Subjects in Clinical Trials- Administrative Orders Monitoring of Clinical Trials - regarding 2013-Feb-17 733 KB
20 Order Dated 06.02.2013: "System for supervision Clinical trials on new Chemical entities in the light of direction of Hon'ble Supreme Court of India" 2013-Feb-06 739KB
21 Notice-dated 11.12.2012: Advisory notice on Clinical Trial 2012-Dec-11 1,240Kb
22 Office Memo.-dated 29.08.2012: Expert committee for finalization of Schedule Y1 (CRO Registration) 2012-Aug-29 297KB
23 Advisory notice on clinical trial 2012-Feb-17 1273 KB
24 Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices 2012-Feb-17 1292 KB
S.no Title Release Date Download Pdf Pdf Size
1 G.S.R.227(E) 19 March 2019 2019-Mar-21 2458 KB
2 Extension of Expert Committee 2018-Feb-09 667kb