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MARA Medicines (Extract application form)IRAS Version 5.16REQUEST FOR Authorization OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS
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How to fill out mhra medicines eudract application

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How to fill out mhra medicines eudract application

01
Go to the MHRA website and navigate to the Medicines Application Portal
02
Click on the 'EudraCT' link to access the EudraCT application form
03
Fill out the required personal information such as your name, contact details, and professional qualifications
04
Provide details about the medicine for which you are seeking approval, including its name, active ingredients, and intended use
05
Include information on the proposed clinical trial, such as the study objectives, study design, and participant recruitment criteria
06
Attach any necessary supporting documents, such as study protocols, investigator brochures, and informed consent forms
07
Review the completed application form for accuracy and completeness
08
Submit the application form electronically through the MHRA Medicines Application Portal
09
Pay the applicable fees for the EudraCT application
10
Await feedback from the MHRA regarding the status of your application

Who needs mhra medicines eudract application?

01
Any individual or organization planning to conduct a clinical trial involving the use of medicines in the UK needs to complete the MHRA Medicines EudraCT application. This includes pharmaceutical companies, research institutions, and healthcare professionals.
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The MHRA Medicines EUdraCT application is an electronic system used to submit clinical trial applications in the UK.
Sponsors or applicants conducting clinical trials in the UK are required to file the MHRA Medicines EUdraCT application.
To fill out the MHRA Medicines EUdraCT application, applicants need to create an account on the system and enter all required information about the clinical trial.
The purpose of the MHRA Medicines EUdraCT application is to streamline the process of submitting and reviewing clinical trial applications in the UK.
The MHRA Medicines EUdraCT application requires information about the study protocol, investigators, study medication, and other relevant details of the clinical trial.
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