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Clinical Data Aquisition and Documentation

By: Admin
Date: January 08, 2010

Clinical Trial Data can be collected in any of the following methods: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems. The quality of the data directly depends on the quality of the instrument used to make measurements. Proper data points collected result in a meaningful analysis of the entire Clinical Trial. The document is referred to as Case Report Form or CRF. A Case Report Form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.

Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial.The protocol is defined to safegaurd the health of the participants and answer specific research questions. The protocol clearly defines the type of subjects, the schedule of tests, procedures, medications, and dosages; and the length of the study.

CRF is designed in line with the protocol defined for the specified Clinical Trial. The process of designing, developing, approval and version control needs to be documented. It needs to be available on the clinical site prior to enrollment of any subject. Personnel need to be trained on the protocol, CRF completion instructions and data submittal procedures prior to enrollment of a subject. 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. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. The supervising Institutional Review Board (IRB) oversees the release of any personally identifiable data to the sponsor.

Best practices

Design the CRF along with protocol to assure collection of only the se data the protocol specifies.
Keep questions, prompts and instructions clear and concise.
Design the CRF to follow the data flow from the perspective of the person completing it, taking into account the flow of study procedures and typical organization of data in a medical record.
Avoid referential and redundant data points within the CRF whenever possible. If redundant data collection is used to assess data validity, the measurements should be obtained through independent means.
Design the CRF with the primary safety and efficacy endpoints in mind as the main goal of data collection.
Establish and maintain a library of standard forms.
Make the CRF available for review at the clinical site prior to approval.
Use NCR (no carbon required) paper or other means to assure exact replicas of paper collection tools.