Get Name Of National Regulatory Authority Procedure ... - Who

Navigating the submission process for clinical trial applications can seem daunting. This guide provides users with clear, step-by-step instructions on how to fill out the National Regulatory Authority's Clinical Trial Application form effectively and efficiently.

Follow the steps to accurately complete the application form.

1. Press the ‘Get Form’ button to access the Clinical Trial Application form and open it in your preferred editor.
2. Begin with Section 1, where you will need to enter the title of the study, protocol number, and the contact person’s details, ensuring all information is accurate and complete.
3. Move to Section 2 to provide the basic administrative data regarding the applicant and sponsor, including names, addresses and contact information.
4. In Section 3, outline the investigational medicines to be used in the trial. Include details such as the name, registration number, and manufacturer. Make sure to complete all subsections for clarity.
5. Section 4 requires listing sites and investigators. Provide the physical addresses, qualifications, and contact details for each site, ensuring that each investigator is compliant with necessary protocols.
6. Proceed to Section 5 to specify participant information, including the number of participants expected to enroll, duration of the trial, and intended compensation.
7. Assemble and review all required documents listed in the checklist, ensuring that each item is completed and included in the application package.
8. Finally, save your changes and download the completed form. Review it for any missing information before submitting it to the appropriate regulatory authority through the provided channels.

Ready to conduct your clinical trial? Complete the application form online today.