12. Resources (listed in descending order of precedence)
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12. Resources (listed in descending order of precedence)
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- Central Drugs Standard Control Organization (CDSCO) About CDSCO, CDSCO.
- National Institute of Allergy and Infectious Diseases (NIAID) India, NIAID.
- Indian Council of Medical Research (January 2017) Handbook for Applicants & Reviewers, Indian Council of Medical Research.
- National Institute of Allergy and Infectious Diseases (NIAID) Timeline of Review, NIAID.
- Central Drugs Standard Control Organization Directorate General (CDSCO)(n.d.), Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials, CDSCO.
- Central Drugs Standard Control Organization Directorate General (CDSCO)(n.d.) Central Drugs Standard Control Organization (Import & Registration Division) Guidance Document, CDSCO.
- Genetic Engineering Appraisal Committee (2017)(n.d.) Relevant Acts and Rules, Ministry of Environment and Climate Change, Government of India.
- Central Drugs Standard Control Organization (CDSCO)(n.d.) New Drugs and Clinical Trials 2019, CDSCO.
- National Institute of Medical Statistics (ICMR)(n.d.) Clinical Trials Registry, ICMR.
- National Institute of Allergy and Infectious Diseases (NIAID)(n.d.) Ethics Committee, NIAID.
- Central Drugs Standard Control Organization (CDSCO)(n.d.) The Gazette of India, CDSCO.
- National Institute of Allergy and Infectious Diseases (NIAID)(n.d.) Progress Reporting, NIAID.
- National Single Window System (NSWS) India’s National Single Window System for Business Approvals | NSWS.
- Indian Council of Medical Research (ICMR) (2017) National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, ICMR.
- National Institute of Allergy and Infectious Diseases (NIAID)(n.d.) Submission Content, NIAID.
- Pharmaphorum (22 August 2016) Regulatory timelines in the Asia-Pacific, Pharmaphorum.
- National Institute of Allergy and Infectious Diseases (NIAID)(n.d.) Required Elements, NIAID.
- Central Drugs Standard Control Organisation (CDSCO)(n.d.) Guidelines for uploading data for Manufacturing and Formulation data, CDSCO.
- Central Drugs Standard Control Organization (CDSCO)(n.d.) Approval process for Form-44/TL. Application received Online Sugam Portal with respect to Global Clinical Trials Division, CDSCO.
- The Information Technology Act (2008)
- Majmudar G (2020) Decentralized Clinical Trials in APAC Here to Stay, Global Forum.
- Drugs and Cosmetics Act (1940)
- Central Drugs Standard Control Organisation (CDSCO)(n.d.) GCT Checklist, CDSCO.
- DocuSign (30 August 2021) eSignature Legality in India, DocuSign.
- The Gazette of India (11 April 2011) Ministry of Communications and Information Technology (Department of Information Technology), The Gazette of India.
- Baker Mckenzie (n.d.) International Data Transfer | India | Global Data Privacy and Cybersecurity Handbook | Baker McKenzie Resource Hub, Baker McKenzie.
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