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This document is a case report form for pertussis, used to collect detailed information about each case including personal details, diagnosis, clinical features, risk factors, and management.
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How to fill out case report form
How to fill out CASE REPORT FORM
01
Read the instructions carefully before starting.
02
Fill in the patient's personal information, including name, age, and contact details.
03
Describe the medical history relevant to the case, including previous illnesses and treatments.
04
Document the current medical condition and symptoms the patient is experiencing.
05
Include any examinations or tests performed, along with their results.
06
Record the treatments administered, including dosage and frequency.
07
If applicable, note down any adverse effects observed.
08
Ensure all required signatures and dates are added at the end of the form.
09
Review the completed form for accuracy and completeness before submission.
Who needs CASE REPORT FORM?
01
Healthcare professionals involved in clinical trials.
02
Researchers collecting data for medical studies.
03
Regulatory bodies monitoring drug safety and efficacy.
04
Clinical coordinators managing patient care in trials.
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People Also Ask about
How to create a case report form?
Standard Case Report Form Design Structured format following scientific methodology and regulatory requirements. Organized by study visit to capture all protocol-required measures sequentially. Standardized questions/response options allowing quantitative analysis across participants.
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 are the two types of CRF?
The two types are paper-based CRF and electronic case report form design (eCRF).
Who makes case report form?
CRFs are designed by the sponsor or sponsor-investigator and maintained at the investigative site. Information documented on the CRF (or eCRF) must be supported by source documentation. At a minimum the CRF should record: Inclusion/exclusion criteria and assessment as to whether the subject met them.
How to develop CRF?
Designing an Optimal CRF Avoid Duplication: Collect only data specified by the protocol, avoiding referential and redundant data points within the CRF. Be Clear and Concise: Keep the CRF's questions, prompts, and instructions clear and concise, using understandable language that avoids unnecessary technicalities.
How to design a CRF?
CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis.
What is the difference between EDC and CRF?
An Electronic Data Capture (EDC) System is a software application that helps streamline the process of collecting, storing, and securing data from clinical studies, while an electronic Case Report Form (eCRF) is the digital version of a Case Report Form (CRF) used by researchers to record data from about patients
What is the purpose of a case report form?
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
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What is CASE REPORT FORM?
A Case Report Form (CRF) is a document used in clinical trials to collect data from each participant. It provides a structured format for recording information regarding the participant's medical history, treatment, and outcomes.
Who is required to file CASE REPORT FORM?
The principal investigator, study coordinators, and authorized personnel involved in the clinical trial are responsible for filling out and filing the Case Report Form.
How to fill out CASE REPORT FORM?
To fill out a Case Report Form, one must accurately record all relevant data according to the specified guidelines, ensuring that all fields are completed as required, using clear and legible handwriting or electronic data entry, and following any protocols established for data accuracy and integrity.
What is the purpose of CASE REPORT FORM?
The purpose of a Case Report Form is to systematically collect data for clinical trials, ensuring that it is organized and standardized for analysis, which facilitates regulatory compliance and contributes to the evaluation of a treatment's safety and efficacy.
What information must be reported on CASE REPORT FORM?
The information that must be reported on a Case Report Form typically includes patient demographics, medical history, laboratory results, administered treatments, responses to interventions, and any adverse events experienced during the study.
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