BASICS OF CASE REPORT FORM DESIGNING IN CLINICAL RESEARCH

 Introduction

A case report form (CRF) is intended to collect patient data during a clinical trial; its creation is a significant undertaking that can impact the research outcome. Site staff record the subject's information on the CRF, gathered when they participated in a therapeutic experiment. The CRF is described as a printed, optical, or electronic document meant to capture all of the protocol-required information to be submitted to the sponsor on each trial subject by the International Conference on Harmonization Guidelines for Good Clinical Practice.

Designing a case report form needs extensive planning and close attention to detail. In order to effectively analyze the safety and efficacy of the pharmaceutical product, it is essential to design a CRF for clinical trials.

More and more people are realizing that the CRF's (paper) design (in written form or electronic form) is a crucial step in assuring the data needed for protocol compliance, legal requirements, and/or safety concerns, characteristics of the hypothesis’s specific to the investigation, cross-checking of data elements inside a site's workflow addressed inside a form or across forms. Clinical research uses the CRF, which simplifies complex clinical realities into rounded numbers and categorical responses. 

Difference between paper case report form and electronic case report form

Traditional paper CRFs and improvised electronic CRFs are the two forms of CRFs employed in clinical research (eCRF). While eCRFs are taken into consideration if studies are big with identical designs, paper CRFs are the more common method of data collection and a superior choice if studies are small or varied in design.

When creating a CRF, keep the following things in mind.

• Consistent use of font sizes, styles, and formats across the CRF booklet.
• Choosing between portrait, landscape, and hybrid layouts.
• Use of precise and concise instructions, queries, and prompts.
• At the proper times, specific instructions on skip patterns, such as what to skip and what not to skip, should be provided.
• Separate the columns with thick lines.
• Provide bold and italicized instructions.
• Minimize free text responses.
• If required, pages should be consistently numbered throughout.
• To avoid making assumptions about the clinical data, do not use the phrase "check all that apply."
• Indicate the measurement's unit.
• Indicate the number of decimal places to be recorded.
• Throughout the CRF, use standard data format (e.g., dd/mm/yyyy).
• To ensure the CRF's identical reproduction, use "no carbon necessary" copies.

Standard case report form templates

Demographic, PE, and AE data needs are some of the same across studies, therefore common CRF templates should be created that can be adjusted as needed. These templates are quite helpful when carrying out several investigations in the same field of study. There is no need for specialized training on these CRF modules because these templates will have the same design principles that make it easier for the user to enter data because they are acquainted with the design.

Challenges in case report form designing

Consistency in the design, gathering exact data, and user-friendliness are frequent difficulties in CRF designing. A group of data management professionals, biostatisticians, doctors, and medical writers may overcome these difficulties with careful preparation. Another problem is superfluous data collection, which should be avoided since processing it is time-consuming. In these circumstances, assuring accuracy and quality present significant difficulties. To prevent duplication, care should be taken. Avoid referential and duplicate data collecting when creating the CRF.  

Case report form completion guidelines

A CRF completion guideline is a document created simultaneously with the CRF and procedure to help the investigator finish the CRF in a step-by-step fashion. Due to the fact that CRF completion instructions are study-specific, there is no uniform template. It should be created in a fashion that makes it possible for the site staff to easily and legibly complete the CRFs.

Conclusion

Designing case report forms is the first stage in converting the protocol into typical questionnaires, and it is essential to a clinical trial's success. The purpose of a standard CRF should be to facilitate the collection of reliable data, which will lead to its submission to regulatory bodies and eventual adoption. The right data points (answer to a CRF question/data is input) must be gathered regardless of the time and effort put into running the trial. Otherwise, a meaningful analysis may not be achievable. These general recommendations will help in creating a CRF that is well-designed for data collection.

References

1.    Bellary, S., Krishnankutty, B. and Latha, M.S., 2014. Basics of case report form designing in clinical trials. Perspectives in clinical research, 5(4), p.159.

2.    Bellary, S., Krishnankutty, B. and Latha, M.S., Journal: Basics of case report form designing in clinical research.

3.    Sheean, A.J., Gasbarro, G.V., Abedelatif, N.M. and Musahl, V., 2019. How to Perform a Clinical Study. Basic Methods Handbook for Clinical Orthopaedic Research: A Practical Guide and Case Based Research Approach, p.307.

4.    Rison, R.A., 2013. A guide to writing case reports for the Journal of Medical Case Reports and BioMed Central Research Notes. Journal of Medical Case Reports, 7(1), pp.1-9.

 

  

Written by: Ashwini Tamkhane

Qualification: Bachelor of pharmacy

ID.no: CSRPL_INT_ONL_WKD_161/0922