Get the free AE Case Report Form - acrin

This form is used to report adverse events and serious adverse events in accordance with the ACRIN study protocol. It requires detailed information about the event, including descriptions, grading,

How to fill out ae case report form

How to fill out AE Case Report Form

1. Start by entering the patient's identification information including name, age, and contact details.
2. Provide the details of the adverse event, including the date it occurred and a description of the event.
3. Include information about the medication involved, such as the name, dosage, and route of administration.
4. Document any relevant medical history or underlying conditions the patient may have.
5. Note any other treatments or medications the patient was using during the time of the adverse event.
6. Indicate the outcome of the adverse event if known (e.g., resolved, ongoing, resulted in hospitalization).
7. Sign and date the form to verify the information provided is accurate.

Who needs AE Case Report Form?

1. Healthcare professionals who encounter adverse events in patients during treatment.
2. Pharmaceutical companies that must report adverse events related to their products.
3. Regulatory authorities that collect data on drug safety for evaluation.

People Also Ask about

What are case reports and examples?

An article that describes and interprets an individual case, often written in the form of a detailed story. Case reports often describe: Unique cases that cannot be explained by known diseases or syndromes. Cases that show an important variation of a disease or condition.

Do you need permission to write a case report?

Historically, case reports were published without consent of the patient. However, standards have been evolving in law and ethics such that consent should now be viewed as mandatory.

How do you write a case report format?

Case reports should encompass the following five sections: an abstract, an introduction with a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, and a brief summary of the case and a conclusion.

How to make a case report form?

[7] In general, the header includes protocol ID, site code, subject ID, and patient initials. Whereas, the footer includes investigator's signature, date of signature, version number, and page number. In order to enhance easy reading/understanding and accurate data entry, an uncrowded CRF layout should be preferred.

What is the composition of the case report form?

A Case Report Form consists of three main parts: a header, a safety-related module and an efficacy-related module.

What are the 4 criteria for adverse event reporting?

​ When all entries and corrections are deemed to be complete, the CRF must be signed by the principal investigator (or designee) to assert that they believe it to be complete and correct.

What should be reported as an AE?

Any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.

For pdfFiller’s FAQs

What is AE Case Report Form?

The AE Case Report Form (AE CRF) is a standardized document used in clinical trials to collect detailed information about adverse events experienced by participants.

Who is required to file AE Case Report Form?

The AE Case Report Form is typically filed by clinical investigators, trial coordinators, or any authorized personnel involved in monitoring the safety of trial participants.

How to fill out AE Case Report Form?

To fill out the AE Case Report Form, one should provide accurate information about the adverse event, including the type, severity, duration, relationship to the study treatment, and any actions taken.

What is the purpose of AE Case Report Form?

The purpose of the AE Case Report Form is to systematically document adverse events to ensure participant safety, comply with regulatory requirements, and analyze the safety profile of investigational treatments.

What information must be reported on AE Case Report Form?

The AE Case Report Form must include details such as patient demographics, description of the adverse event, severity, onset and resolution dates, treatment administered, and any relevant medical history.