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13.1. Annex 1 FORM PCT001.03: Clinical Trial Application review checklistPharmacovigilance & Clinical Trial Lead Executive Officer PCT001.03 SOP/ PCT_CT001TitleClinical Trial Application review checklist Clinical

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How to fill out routine clinical trial application

01

Gather all necessary documents and information, including study protocol, investigator brochure, informed consent forms, and organizational approvals.

02

Complete the required application form with accurate and detailed information about the trial, including study objectives, design, procedures, and participants.

03

Submit the application form along with all supporting documents to the appropriate regulatory body or ethics committee for review.

04

Address any feedback or requests for additional information from the regulatory body or ethics committee in a timely manner.

05

Await approval from the regulatory body or ethics committee before initiating the clinical trial.

Who needs routine clinical trial application?

01

Researchers and organizations conducting clinical trials

02

Regulatory bodies and ethics committees overseeing clinical research

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What is routine clinical trial application?

A routine clinical trial application is a formal request submitted to regulatory authorities to seek approval for conducting clinical trials. It outlines the study's design, objectives, and methodology.

Who is required to file routine clinical trial application?

Researchers or sponsors planning to conduct clinical trials, including pharmaceutical companies, academic institutions, and contract research organizations, are required to file a routine clinical trial application.

How to fill out routine clinical trial application?

To fill out a routine clinical trial application, researchers should follow the specific guidelines set by the regulatory authority, including providing detailed information about the trial protocol, objectives, participant eligibility, funding sources, and any previous research related to the drug or treatment.

What is the purpose of routine clinical trial application?

The purpose of a routine clinical trial application is to obtain regulatory approval to ensure that the proposed clinical study is conducted ethically and safely, and that it complies with all regulatory requirements.

What information must be reported on routine clinical trial application?

The application must report information such as the trial design, research objectives, participant selection criteria, informed consent processes, safety monitoring plans, data management plans, and potential risks and benefits.

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