Case Report Form Design for Clinical Trial

FOR IMMEDIATE RELEASE
Tamil Nadu, Chennai, India, Republic of (Free-Press-Release.com) September 19, 2011 --

A Case Report Form is an electronic or paper questionnaire specifically used in clinical trial research. The Case Report Form is the tool used to sponsor of the clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held documented in CRF. The sponsor of the clinical trial develops use the CRF to collect specific data, they need in order to test their hypotheses or answer their research questions. The size of the CRF range from handwritten one-time snapshot of a patient's physical condition to hundreds of pages in electronically captured data obtained over a period of weeks or months. It can also include all the required check-up and visits months after the patient's treatment has stopped.

The sponsor is responsible for all the designing of CRF that accurately represents the protocol of clinical trial, and managing its production, monitoring the data collection and auditing the content are filled-in CRF. Case report form contains all the data obtained during the patient's participation in clinical trial. Before sent to the sponsor, this data is usually de-identified that is not traceable to the patient, by removing the patient's name, medical record number, etc., and giving the patient unique study number. The monitoring oversees the release of any personally identifiable data to the sponsor by Institutional Review Board (IRB).

The main logistic goal of a clinical trial is to be obtaining accurate CRF from sponsor's point. Because of human and machine error, the data entered in CRF is rarely completely accurate or entirely readable. When the study of administrators or automated mechanisms processes the CRF, it was sent to the sponsor by local researchers, they use to make a note of queries. Queries are non-sensible or questionable data that must be explained.

Case report forms should be built for:

• Gather all the accurate information that answer study questions, and is consistent with study protocol.
• Organize and label forms and fields so that data entry is non-rational.
• Avoid the duplication of data.

Reasons for Standard case report form templates:

• Eliminate Form Duplication: Some of the data requirements are same across studies, such as demographics, admission checklists, concomitant medications, and adverse events. This is especially true for organizations that carry out multiple studies in the same research area.
• Simplify Creating New Case Report Forms: There is no need to start from scratch, templates can be customized.

• Reduce the Data Entry Learning Curve: Templates are using the same visual style and basic organization become familiar to entering data, reducing the data entry learning curve.

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