Get the free Article 57 QuickCard - Use of data elements in the eXtended EudraVigilance Medicinal...

9 June 2015 EMA/339616/2014 Information Management Article 57 Quicksand Use of data elements in the extended EudraVigilance Medicinal Product Dictionary (DEEMED) 30 Churchill Place ? Canary Wharf

How to fill out article 57 quickcard

1. To fill out article 57 quickcard, you first need to gather the necessary information. This includes the name of the person filling out the quickcard, the date, and any additional contact details that may be required.
2. Next, you will need to understand the purpose of article 57 quickcard. It is a form used to document employee or contractor infractions or violations. This may include disciplinary actions, performance issues, or any other misconduct that needs to be reported.
3. Begin by filling out the employee or contractor's information on the quickcard. This includes their name, identification number, department, and position. It is important to be as accurate as possible to ensure the quickcard is properly documented.
4. Provide a detailed description of the infraction or violation that occurred. This should include specific details such as the date, time, location, and any witnesses present. Be clear and concise in your description, providing enough information for future reference or investigation if needed.
5. Indicate the severity of the infraction or violation. This can typically be done by selecting a defined scale or using keywords such as minor, moderate, or major. This helps determine the appropriate actions or consequences that may follow.
6. If applicable, list any previous warnings or actions taken in relation to the employee or contractor. This helps provide a complete history and context for the current incident.
7. Include any supporting documentation or evidence that can substantiate the infraction or violation. This may include photographs, emails, messages, or any relevant documents. Ensure that all documentation is properly labeled and attached to the quickcard for easy access.
8. Finally, review the completed quickcard for accuracy and completeness. Double-check all information, verify that all sections have been properly filled out, and ensure that it aligns with company policies and procedures.

Who needs article 57 quickcard?

1. Employers or supervisors who need to document employee or contractor infractions or violations.
2. Human resources departments that require accurate and detailed records for maintaining employee documentation.
3. Legal departments that may need the quickcards for future legal proceedings or investigations.
4. Compliance departments that monitor and enforce company policies and regulations.
5. Any individual or entity responsible for handling disciplinary actions and maintaining accountability within an organization.

By properly filling out the article 57 quickcard and understanding who needs it, you can ensure effective documentation and appropriate action for any incidents or violations that arise.

For pdfFiller’s FAQs

What is article 57 quickcard?

Article 57 quickcard is a form used to report information on certain qualifying clinical trials. It is a requirement under the European Union Clinical Trial Regulation to provide transparency and accountability in clinical research.

Who is required to file article 57 quickcard?

The sponsor or the legal representative of the sponsor is required to file the article 57 quickcard for qualifying clinical trials.

How to fill out article 57 quickcard?

The article 57 quickcard can be filled out electronically through the EU Clinical Trials Information System (EudraCT). The sponsor or legal representative must provide all the required information accurately.

What is the purpose of article 57 quickcard?

The purpose of article 57 quickcard is to provide public access to key information about clinical trials, promote transparency, and facilitate regulatory oversight.

What information must be reported on article 57 quickcard?

The article 57 quickcard must include information such as the identification of the sponsor, protocol information, trial status, and results-related information.

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