CT-REC - NABH

Resources for Clinical Trial

Approval from Ministry-Ethics Committee Accreditation

New Drug & Clinical Trial Rules-Highlights for Ethics Committee and Clinical Trial

Gazzete Notification G.S.R227(E)-NDCT Rule 2019

ICMR National Ethical Guidelines 2017

Guidelines on Good Clinical Practice (GCP) -Clinical Trial

National Ethical Guidelines for BioMedical Research Involving Children

Permission to Conduct BA, BE Studies and Clinical Trials in India

Notice-Application at SUGAM Portal According to NDCT Rule 2019

Drugs & Cosmetics Act 1940 Rules1945

Important Notice-Inclusion of Medical devices as Drugs

Guidelines for Monitoring of Clinical Trials

Clarification Regarding Stability Data Requirement-Clinical Trials & BA, BE Study

Notice-Independent Ethics Committee for Clinical Trials

Ethics Committee Guidance during COVID19-By ICMR

Formula-Compensation in the Cases of Clinical Trials Related to Injury

Formula-Compensation in the Cases of Clinical Trials Related to SAEs Death

Resource material of Pharmacovigilance programme of India

Resource material of Materiovigilance programme of India

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