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An analysis of the individual case- report forms Ministry of Health

An analysis of the individual case- report forms Ministry of Health 2025

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The document analyzes the epidemiological trend of tuberculosis (TB) in Italy from 1992 to 1994, based on 13,639 individual case-report forms. It highlights a resurgence of TB, particularly extrapulmonary forms, after a period of decline. The study compares TB cases in the general population and among AIDS patients, assesses incidence rates among foreigners, and notes an increase in TB cases primarily affecting males aged 20-35 and 60-80. The findings indicate a significant public health concern due to rising incidence rates and the influence of factors such as drug resistance and HIV.

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What are the two types of CRF?

2 CRFs. In Oracle Clinical and RDC Classic, the term CRF, which is an acronym for Case Report Form, refers to the form that is used by investigators to collect information and data about a patient in the clinical trial. This form can be either paper or electronic.

What is the difference between paper CRF and eCRF?

Paper-based CRF forms must be transcribed into a computer database before analysis, which introduces the potential for transcription errors. Collecting data electronically with eCRF eliminates transcription errors and results in better quality data.

Who should be signing off the case report forms?

4.3 Investigator: The Investigator is responsible for timely review and sign-off of the eCRFs to ensure accuracy, and completeness, in compliance with the protocol and regulations.

What is the main purpose of the case report form?

A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant.

What is the difference between CRF and annotated CRF?

An annotated CRF is generally defined as a blank CRF with markings, or annotations, that coordinate each datapoint in the form with its corresponding dataset name. Essentially, an annotated CRF communicates where the data collected for each Question is stored in the database.

What is the difference between EDC and eCRF?

There is a difference between EDC and eCRF. Electronic data capture, EDC, is a software used for collecting clinical trial data. An electronic case report form, or eCRF, is a digital (usually web-based) questionnaire for collecting data about a study participant.

What are individual case reports?

Definition. 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.

What is paper CRF?

A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. It enables efficient and complete data collection, processing, analysis and reporting.

An analysis of the individual case- report forms Ministry of Health 2025

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