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This document provides the latest version dates for various case report forms (CRFs) and the instructions for completing them in EpiSurv.
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How to fill out version dates for case

How to fill out Version dates for case report forms and instructions
01
Identify the specific case report form (CRF) you are working on.
02
Locate the section designated for Version dates, often found at the top or bottom of the form.
03
Enter the date that the current version of the CRF was finalized.
04
Include the version number to distinguish it from previous versions.
05
If applicable, add a separate field for the initial draft date or any prior revisions.
06
Review for accuracy and consistency with other forms used in the study.
07
Save or submit the CRF according to the established protocol for documentation.
Who needs Version dates for case report forms and instructions?
01
Researchers and clinical trial sponsors who need to ensure compliance and tracking of changes.
02
Data managers who are organizing the collection and management of data.
03
Regulatory bodies requiring accurate documentation in clinical trials.
04
Auditors reviewing records for quality assurance and adherence to protocols.
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People Also Ask about
What is the format of the CRF?
Use standard data format (e.g., dd/mm/yyyy) throughout the CRF. Use precoded answer sets such as yes/no, male/female, method of administration of medicine, and severity of adverse event (AE) (mild/moderate/severe) wherever possible.
What is CRF and eCRF in clinical trials?
An eCRF (electronic case report form) is the digital version of a paper-based case report form - it's a digital questionnaire completed by researchers to collect and report data from participating patients in a clinical trial.
What is the CRF common reporting format?
A standardised format for reporting estimates of greenhouse gas (GHG) emissions and removals and other relevant information by Annex I Parties.
What is the CRF file format?
An extensible markup language (XML) file format developed by Itron to enable software applications with different native file formats to exchange meter route and energy use data.
What is ICH GCP case report form?
According to ICH GCP EC 1.11, a case report form is a printed, optical, or electronic document designed to record all of the protocol required information to be reported on each trial subject. CRFs are designed by the sponsor or sponsor-investigator and maintained at the investigative site.
What is the CRF guideline?
A CRF completion guideline is a document to assist the investigator to complete the CRF in a step by step manner and is drafted concurrently in line with the CRF and protocol.
What is a CRF document?
A Case Report Form, or CRF, is a research-specific document that collects all the relevant data for a given protocol. Historically, these were completed on paper but for most current studies, data is reported into an Electronic Data Capture database (or EDC).
What is the CRF format?
Case Report Form (CRF): 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 site.
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What is Version dates for case report forms and instructions?
Version dates for case report forms and instructions refer to the specific dates assigned to each version of the forms and instructions used in clinical trials or studies to track the most current guidelines and requirements.
Who is required to file Version dates for case report forms and instructions?
Researchers, clinical trial sponsors, and regulatory agencies are typically required to file version dates for case report forms and instructions to ensure compliance and accurate reporting.
How to fill out Version dates for case report forms and instructions?
To fill out version dates, one must include the date next to the version number on the case report forms and ensure it corresponds to the correct set of instructions that were in effect at the time of data collection.
What is the purpose of Version dates for case report forms and instructions?
The purpose of version dates is to maintain clarity and accountability in data collection processes, allowing for the correct interpretation of the data and ensuring all stakeholders are aligned with the latest guidelines.
What information must be reported on Version dates for case report forms and instructions?
The information that must be reported includes the version number, version date, title of the form, and any relevant instructions associated with that version to ensure proper documentation and compliance.
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