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What is the purpose of the case report form?

A Case Report Form ( CRF ) is a printed or electronic document that is created and used in clinical trial research to capture standardised clinical data from each patient separately and to transfer it to Data Management.

What is a case report form in research?

A case report form (CRF) is a printed, optical, or electronic document designed to record all protocol-required information on each subject in a clinical research study.

What are unique CRF pages?

Unique electronic case report form (eCRF) is a platform in which electronically maintained information about an individual’s lifetime health status and health care records can be stored such that it can serve multiple legitimate users and along with serving as case report form of patients in clinical trials.

What is an annotated case report form?

An annotated case report form ( CRF ) is a blank CRF with annotations that document the location of the data with the corresponding names of the datasets and the names of those variables included in the submitted datasets. All of the pages and each item in the CRF should be included.

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What makes a good case report?

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 do you prepare a case report?

Important part of the CRF is an informative header and footer, which can be customized. [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.

Is a case report form a source document?

 What is a Case Report Form ( CRF )? A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. Provided by the sponsor. Must be checked against the source document.

How should you correct an error in a case report form?

Do you:

  1. Scribble out the date you wrote and then write the correct one next to it.
  2. Try to change the date that you wrote by writing over the numbers.
  3. Draw a line through the previously written date, initial and date next to it, then write the correct date.

How long must clinical trial records be kept?

An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication

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Who prepares CRF?

The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs.

What does eCRF stand for?

Electronic Case Report Forms ( eCRF )

Why do we need an indicator question in CRF?

Indicator branching allows you to control whether or not Questions in a Question Group are collectible for a particular patient depending on that patient’s response to the first Question in the Question Group.

What is aCRF in Sdtm?

The annotated case report form ( aCRF ) is a “PDF document that maps the clinical data collection fields used to capture subject data (electronic or paper) to the corresponding variables or discrete variable values contained within the SDTM datasets”1.

What is Cdisc and Sdtm?

CDISC stands for the Clinical Data Interchange Standards Consortium. The SDTM data sets provide standards for organizing clinical trial data following database lock. The ADaM data sets provide a connection between the SDTM data sets and the final statistical analyses.

What is CDM in clinical research?

Abstract. Clinical Data Management ( CDM ) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing.

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