12. Resources (listed in descending order of precedence)
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12. Resources (listed in descending order of precedence)

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Article summary

  1. Central Drugs Standard Control Organization (CDSCO) About CDSCO, CDSCO.
  2. National Institute of Allergy and Infectious Diseases (NIAID) IndiaNIAID.
  3. Indian Council of Medical Research (January 2017) Handbook for Applicants & ReviewersIndian Council of Medical Research.
  4. National Institute of Allergy and Infectious Diseases (NIAID) Timeline of Review, NIAID.
  5. Central Drugs Standard Control Organization Directorate General (CDSCO)(n.d.), Frequently Asked Questions (FAQs) on New Drugs and Clinical TrialsCDSCO.
  6. Central Drugs Standard Control Organization Directorate General (CDSCO)(n.d.) Central Drugs Standard Control Organization (Import & Registration Division) Guidance DocumentCDSCO.
  7. Genetic Engineering Appraisal Committee (2017)(n.d.) Relevant Acts and RulesMinistry of Environment and Climate Change, Government of India.
  8. Central Drugs Standard Control Organization (CDSCO)(n.d.) New Drugs and Clinical Trials 2019CDSCO.
  9. National Institute of Medical Statistics (ICMR)(n.d.) Clinical Trials RegistryICMR.
  10. National Institute of Allergy and Infectious Diseases (NIAID)(n.d.) Ethics Committee, NIAID.
  11. Central Drugs Standard Control Organization (CDSCO)(n.d.) The Gazette of India, CDSCO.
  12. National Institute of Allergy and Infectious Diseases (NIAID)(n.d.) Progress Reporting,  NIAID.
  13. National Single Window System (NSWS) India’s National Single Window System for Business Approvals | NSWS
  14. Indian Council of Medical Research (ICMR) (2017) National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, ICMR.
  15. National Institute of Allergy and Infectious Diseases (NIAID)(n.d.) Submission Content,  NIAID.
  16. Pharmaphorum (22 August 2016) Regulatory timelines in the Asia-PacificPharmaphorum.
  17. National Institute of Allergy and Infectious Diseases (NIAID)(n.d.) Required Elements,  NIAID.
  18. Central Drugs Standard Control Organisation (CDSCO)(n.d.) Guidelines for uploading data for Manufacturing and Formulation data, CDSCO.
  19. 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 DivisionCDSCO.
  20. The Information Technology Act (2008)
  21. Majmudar G (2020) Decentralized Clinical Trials in APAC Here to Stay, Global Forum.
  22. Drugs and Cosmetics Act (1940)
  23. Central Drugs Standard Control Organisation (CDSCO)(n.d.) GCT Checklist, CDSCO.
  24. DocuSign (30 August 2021) eSignature Legality in India, DocuSign.
  25. The Gazette of India (11 April 2011) Ministry of Communications and Information Technology (Department of Information Technology), The Gazette of India.
  26. Baker Mckenzie (n.d.) International Data Transfer | India | Global Data Privacy and Cybersecurity Handbook | Baker McKenzie Resource Hub, Baker McKenzie.

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