Comprehensive Guide to CRO Registration on CDSCO Portal
A Clinical Research Organization (CRO) plays a crucial role in conducting clinical trials, bioavailability (BA), and bioequivalence (BE) studies. To legally operate in India, a CRO must register on the CDSCO (Central Drugs Standard Control Organization) online portal by submitting essential documents as per the New Drugs and Clinical Trial (NDCT) Rules, 2019. This article provides a detailed list of the documents required for CRO registration on cdscoonline.gov.in.
List of Documents to be uploaded for CRO ( Clinical Research Organiztion) registration on cdscoonline.gov.in portal
Key Documents Required for CRO Registration
1. Details of the authorised person and authorisation letter of the person in-charge as per 9th Schedule of NDCT- Rule, 2019.
2. Constitution of the CRO (Ltd/Pvt Ltd/proprietorship/ hospital / individual LLP etc.)
3. Name & Address of the Director, MoA, Article of Association (AoA), all Directors details
4. Details of facilities, resources, personnel, training etc
5. Details of CRO facilities, resources and staff for handling any oversight of clinical trials and/ or BA/BE studies
6. Educational qualification, training records CV of CRO staff
6. CRO — Site Master File
7. Organogram of CRO
8. SOP for QA and QC OF clin. research at CRO
9. SOP for complete data acquisitions, archeival of data and essential documents
10. SOP for investigators to conduct the CT / BA/ BE Studies.
11. SOP for transferring & assuming study related duties by CRO
12. SOP for maintenance of records (written documents, electronic, magnetic or optical records, scans, etc.), such as protocols, approvals from the DCGI & EC, investigators particulars, blank consent forms, monitor reports, audit certificates, relevant correspondence, reference pages, completed and the final reports
13 List of SOPs with titles
14. accreditation or approval of other regulatory agencies, if any, (self-attested copy) .
15. A brief profile of the specific activities or services undertaken by CRO including facilities, resources and infrastructure
16. Copy of agreement with third party service providers for site management, translation, biostatistics, data management, and laboratory services etc
17. Undertakings to be submitted for the following :-
17.1. Statement proning for all documentation & communication shall be dated, filed and preserved safely for a period of 5- years after completion of such study or for at least 2- years after the expiration date of the batch of the new drug or IND- studied, whichever is later
17.2 statement confirming strict confidentiality shall be maintained during access & retrieval procedures
17.3 Undertaking for constitution or ownership of the CRO, the organisation shall intimate about the change in writing to the CLS within 30- days of such change.
17.4 Undertaking to comply with the conditions imposed on the registration certificate (RC) along with the adherence to other guidelines like GCP – guidelines and provisions of the Drugs Act, 1940, & NDCT- Rules, 2019
17.5 Undertaking to comply with such further requirements, if any, as may be specified by the Govt. of India, under the said Act and rules made thereunder.
17.6 Undertaking to allow the CLA or any person authorised by him in that behalf to enter and inspect the premises and to examine the process or procedure and documents in respect of any clinical trial conducted by them.
Ensuring compliance with regulatory requirements is vital for CRO registration in India. By submitting the necessary documents and undertaking commitments, CROs can obtain the required registration certificate and operate within legal and ethical frameworks. Organizations must maintain transparency, follow GCP guidelines, and adhere to the NDCT Rules, 2019, for successful clinical research operations.
