Ethics Committee Registration & Re-Registration

Ethics Committee Registration & Re-Registration

Complete assistance for IEC/IRB registration, re-registration, documentation, and regulatory compliance. EC registration ensures ethical oversight, as required by NDCT Rule 9 (EC Constitution) and ICMR Section 4 (EC Formation). We streamline submissions to CDSCO for timely approvals, maintaining compliance throughout. We specialize in cooperating with pharmaceutical, biotechnology, and medical device companies to conduct clinical research trials, integrate speedy patient enrollment solutions into clinical trials, and rescue delayed clinical trials/FDA submissions. We offer world-class results in both quality and speed of enrollment. Shree Clinical Research's SOPs meet the highest standards for conducting clinical trials.
Ethics Committee Registration & Re-Registration

Practical Guidelines and Support

Application Preparation

Compile dossiers per CDSCO Form CTS-01 (NDCT Appendix), including SOPs (ICH GCP 3.1), member CVs (diversity per ICMR 4.2), and training logs.

Submission and Tracking

File via the SUGAM portal; monitor status with biweekly follow-ups; address deficiencies within 15 days.

Ongoing Compliance

Support annual renewals (NDCT Rule 9.3), amendments (e.g., membership changes), and reports (SAE summaries per ICH GCP 3.3.2).

Training and Audits

Provide EC-specific GCP sessions (ICMR 4.5); conduct self-audits for quorum and conflict rules.

Query Resolution

Prepare evidence-based responses to CDSCO queries, targeting approval within 90 days.