81 Launching of registration of Clinical Research Organisation applications through SUGAM Portal 2025-Mar-04 1867 KB

1|Page This is a controlled document. Unauthorizedaccess, copyingandreplication areprohibited. Thisdocumentmustnotbecopied inwholeorpartbyanymeans,withoutthewrittenauthorizationofCDAC,Noida.

User Manual for SUGAM-Ane- Governance solution Online Forms Submission CRO(ClinicalResearchOrganisation)

by Central Drugs Standard Control Organisation (CDSCO)

Directorate General of Health Services Ministry of Health & Family Welfare, Government of India Centre for Development of Advanced Computing (A Scientific Society of the Ministry of Electronics and Information Technology, Govt. of India)

Anusandhan Bhawan,C-56/1,InstitutionalAreaBlock-B,Sector-62,Noida-201309 Phone:91-120-2210800Website:www.cdac.in

2|Page

Contents forRegistrationofClinicalResearchOrganisation ...................................................................................... 3 Registrationprocessfornewusers .......................................................................................................... 3 Registrationprocessforexistingusers ..................................................................................................... 4 FORMCT-07B ....................................................................................................................................... 4

3|Page

Application for Registration of Clinical Research Organisation Application for the Form CT07B is now available on SUGAM Portal. Applicants may follow below steps to register themselves as CRO.

Registration process for new users New users can visit the SUGAM Portal and click on Login/Sign-Up. Navigate to sign-up here and select the registration purpose as “Clinical Research Organisation”. Applicants may the fill the registration form as per below screenshot. Please note that the email address mentioned in the username will be used in future for further communication and for the verification of email address upon successful form submission.

Once the email address is verified, competent authority at CDSCO will further review the account request and grant approval accordingly. Once the account is approved by CDSCO, applicants may login into the SUGAM portal.

It is important to complete user profile to enable form submission. Below listed details are required to complete the user profile.  Add Member Details  Add Contact Person Details

4|Page

Registration process for existing users Existing users on SUGAM Portal may submit are quest for additional role from user profile. Applicants may select role as “Clinical Research Organisation”. It is important to complete user profile to enable form submission.

FORMCT-07B Applicants may login into the SUGAM Portal and click on submit application page. Select “GCT Division” as department and “Form CT07B” as the form. Click on the checkbox for the undertaking and click on “Proceed” button to proceed further.

After clicking on “Proceed” button form for CRO registration or renewal will open. Below mentioned details are to be submitted:  Purpose of Application Application in Form CT-07B can be filled either with the registration purpose or renewal purpose.  Correspondence Address Kindly select correspondence address from the drop down menu. In case the address details are not available then the same can be added from “Add Address Details” page from “User Profile” available in top left menu.

5|Page

 Details of Accreditation Select option as “Yes” incase details of accreditation are available. Upon selecting “Yes” additional field will be visible where details of accreditation can be added. In case details of accreditation are not available, kindly select “No”.

Click on the “Save” button to view the preview of the application form. Kindly ensure that the details mentioned in the preview page are in line with the details entered on the application page. Click on “Proceed to Checklist” button in order to view the checklist. Submit necessary documents on all checklist items and proceed further with the payment for the application.

6|Page

On the payment page select “Online” as the mode of payment and the purpose.  Fees for registration application is Rs.500000 Kindly ensure that the payment purpose is selected either as “CRO Registration” or “CRO Renewal” on payment page before generating deposit slip for bharat kosh.

Select desired challan from the drop down menu “Payment Reference Number” and click on “Submit”

7|Page

buttontoproceed further.

Final preview of the application will be displayed, kindly ensure that all details are correct, and payment related details are also captured correctly on preview page. Download system generated legal form by clicking on “Download PDF” button. System generated form needs to be duly signed by the applicant.

8|Page

Click on “Next” button to proceed further with form submission. Kindly upload duly signed copy of legal form on the final submission page and click on “Submit To CDSCO” button. Please note application number for future reference. Acknowledgement email for file submission will be sent on registered email address.

Application will be visible under “Submitted Applications” on applicant dashboard. Applicant may utilize e-vartalap functionality to communicate with concerned division during the course of file processing.

In case of any query applicant may raise ticket for IT-Helpdesk using “Raise Ticket for Help-Desk” option intopleft menu.