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Resources for Clinical Trial
1.
Approval from Ministry-Ethics Committee Accreditation
2.
New Drug & Clinical Trial Rules-Highlights for Ethics Committee and Clinical Trial
3.
Gazzete Notification G.S.R227(E)-NDCT Rule 2019
4.
ICMR National Ethical Guidelines 2017
5.
Guidelines on Good Clinical Practice (GCP) -Clinical Trial
6.
National Ethical Guidelines for BioMedical Research Involving Children
7.
Permission to Conduct BA, BE Studies and Clinical Trials in India
8.
Notice-Application at SUGAM Portal According to NDCT Rule 2019
9.
Drugs & Cosmetics Act 1940 Rules1945
10.
Important Notice-Inclusion of Medical devices as Drugs
11.
Guidelines for Monitoring of Clinical Trials
12.
Clarification Regarding Stability Data Requirement-Clinical Trials & BA, BE Study
13.
Notice-Independent Ethics Committee for Clinical Trials
14.
Ethics Committee Guidance during COVID19-By ICMR
15.
Formula-Compensation in the Cases of Clinical Trials Related to Injury
16.
Formula-Compensation in the Cases of Clinical Trials Related to SAEs Death
17.
Resource material of Pharmacovigilance programme of India
18.
Resource material of Materiovigilance programme of India
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