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This document is used to report cases of Acquired Immunodeficiency Syndrome (AIDS) under Section 74 of the Health Act 1956 in New Zealand. It collects essential information about the patient while

How to fill out case report form

How to fill out CASE REPORT FORM

1. Start with the patient's identification information including name, age, gender, and contact details.
2. Fill out the study identification section, including the study title and site information.
3. Provide a detailed medical history of the patient, including previous illnesses and treatments.
4. Document the current clinical findings, including symptoms and vital signs.
5. Record any laboratory results or diagnostic imaging outcomes pertinent to the case.
6. Include information about the treatment provided, including medications, dosages, and durations.
7. Note any adverse events or complications experienced during the treatment.
8. Fill out follow-up information, including patient outcomes and any further care provided.
9. Sign and date the form to confirm accuracy and completion.

Who needs CASE REPORT FORM?

1. Clinical researchers collecting data for trials.
2. Healthcare providers reporting adverse events or outcomes.
3. Regulatory agencies monitoring treatment efficacy and safety.
4. Pharmaceutical companies conducting post-marketing surveillance.

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.

For pdfFiller’s FAQs

What is CASE REPORT FORM?

A Case Report Form (CRF) is a document designed to collect data in a systematic and organized manner for clinical trials and research studies.

Who is required to file CASE REPORT FORM?

Researchers, clinical trial sponsors, and investigators conducting studies involving human subjects are required to file Case Report Forms.

How to fill out CASE REPORT FORM?

To fill out a Case Report Form, one must carefully follow the provided instructions, ensure that all requisite data points are accurately completed, and sign where necessary to confirm the information is correct.

What is the purpose of CASE REPORT FORM?

The purpose of a Case Report Form is to standardize the collection of data, facilitate tracking of patient information, and ensure compliance with regulatory requirements during clinical trials.

What information must be reported on CASE REPORT FORM?

Information that must be reported on a Case Report Form typically includes patient demographics, clinical findings, laboratory results, treatment details, and outcomes related to the clinical trial.