December 30, 2024

In a bid to streamline the process of clinical trial approvals in India, the Central Drugs Standard Control Organization (CDSCO) has enhanced the functionalities of the Sugam Portal, allowing sponsors and researchers to efficiently submit clinical trial site applications and update Principal Investigators (PIs) for Global Clinical Trials, Clinical Trials of New Drugs, Subsequent New Drugs, Investigational New Drugs, Fixed Dose Combinations and Bioavailability & Bioequivalence studies.

The proposed addition of a new clinical trial site is automatically deemed approved if CDSCO does not raise any objections within 30 days of receiving the complete application as per checklist. Further, the change of principal investigator is considered approved from the date of receipt of the complete application, provided the application meets all checklist requirements.

What is the Sugam Portal?

The Sugam Portal, an online platform introduced by the Ministry of Health and Family Welfare (MOHFW), aims to simplify the submission and approval process for clinical trials in India. It provides a centralized and transparent system to manage the regulatory requirements of clinical trials.

Submitting Applications for Site Addition and Principal Investigator Change

To apply for the addition of a clinical trial site or a change in the principal investigator, applicants must follow a specific procedure:

  1. Online Application: Applications for site addition or changes to the principal investigator should be submitted through the Sugam portal. This online submission system replaces the traditional paper-based process, making it more convenient and efficient.
  2. Checklist of Documents: As part of the submission, applicants must ensure that they include all necessary documents outlined in the checklist. This includes approval from the ethics committee, which is a critical requirement for the application to be processed.

Key Takeaways:

  1. Streamlined Approval Processes:
    • Site Addition: Automatic approval if no objections are raised within 30 days.
    • PI Change: Considered approved upon submission of a complete application.
  2. Document Requirements:
    • Comprehensive checklist adherence is crucial to ensure smooth application processing.
  3. Advantages of the Sugam Portal:
    • Simplified submission process.
    • Elimination of paper-based procedures.
    • Transparency in application tracking.
  4. Impact on Clinical Trials:
    • Accelerates trial setup timelines.
    • Facilitates compliance with international regulatory standards.
    • Encourages quicker delivery of innovative therapies to the market.

 

Frequently Asked Questions (FAQ)

  1. What is the Sugam portal?

The Sugam portal is an online platform developed by the Central Drugs Standard Control Organization (CDSCO) for submitting regulatory applications related to clinical trials. It streamlines the process for adding clinical trial sites and changing the principal investigator for clinical studies.

  1. How do I submit an application for adding a clinical trial site or changing the principal investigator?

You can submit your application through the Sugam portal (www.cdscoonline.gov.in). The portal requires you to upload the necessary documents, including the ethics committee approval, and follow a checklist for the application.

  1. What documents are required for submitting an application for site addition or principal investigator change?

You need to submit a checklist of documents, including:

    • Ethics committee approval
    • Relevant clinical trial information
    • Any other required documentation as per the checklist on the Sugam portal.
  1. How long does it take to get approval for adding a clinical trial site or changing the principal investigator?
    • Clinical Trial Site Addition: The addition of a site is automatically approved if there are no objections from CDSCO within 30 days of application submission.
    • Principal Investigator Change: The change is deemed approved from the date of submission of the complete application, assuming it meets the checklist requirements.

 

How Vaayath can help

“Vaayath” offers a best solution to these challenges. We streamline the entire application process by providing document checks, ensuring that all required paperwork is properly filled out and we also provide all the support for all types of DCGI/CDSCO permissions.

 Please feel free to contact us on vaayath@gmail.com for any clarification or support in filing of applications.

Conclusion

The move to the Sugam portal marks a major advancement in making the process of adding clinical trial sites and changing principal investigators more efficient, transparent, and user-friendly. It ultimately supports the quicker progress of clinical trials, ensuring that new medical treatments reach the public faster.

 

Reference: DCGI order dated 26.12.2024