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CONTRACT FOR CONDUCTING CLINICAL TRIALS WITH MEDICINESTitle: (complete title of trial)Protocol code: (code of protocol assigned by Sponsor)Extract No.: (Extract code)In, on of 201, I. By and between
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How to fill out create a eudract number

01
To fill out and create a eudract number, follow these steps: 1. Access the official website of EudraCT.
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If you are a new user, register an account on the website.
03
Log in to your account using your credentials.
04
Navigate to the 'Create New EudraCT Number' section.
05
Fill in the required information such as the study protocol, sponsor details, and study information.
06
Upload any necessary documents or attachments as specified by the system.
07
Review the entered information and make any necessary corrections.
08
Submit the application for a new EudraCT number.
09
Wait for the approval process and follow any additional instructions provided.
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Once your application is approved, you will receive a unique EudraCT number for your clinical trial.

Who needs create a eudract number?

01
Various stakeholders in the field of clinical research may need to create a EudraCT number, including:
02
- Pharmaceutical companies sponsoring clinical trials
03
- Contract research organizations (CROs) managing clinical trials
04
- Academic institutions conducting clinical research
05
- Independent investigators conducting clinical trials
06
- Regulatory authorities overseeing clinical trials
07
- Ethics committees reviewing clinical trial protocols

What is Create a EudraCT Number - European Union Form?

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A EudraCT number is a unique identification number assigned to a clinical trial conducted in the European Union. It is used to facilitate the identification and reporting of clinical trials within the European Clinical Trials Database.
Sponsors of clinical trials, which may include pharmaceutical companies, academic institutions, or other organizations responsible for initiating and managing the trial, are required to file for a EudraCT number.
To obtain a EudraCT number, sponsors must register their clinical trial on the EudraCT database by providing specific trial information, including the trial's title, objectives, design, and other relevant details.
The purpose of the EudraCT number is to enhance transparency in clinical trials and provide a standardized way to identify and track studies across Europe, ensuring ethical compliance and informing public health decisions.
Information that must be reported includes the trial's title, protocol number, sponsor information, phase of the trial, objectives, design, and estimated start and end dates, among other details.
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