Basics of case report form designing in Clinical research
Introduction
Case report form (CRF) is an important document in clinical research. It is available in either an electronic form or paper form. This is used in a clinical trial to record the protocol and the necessary information about each participant. It is driven by study protocol and contains sections to collect study-specific data. CRFs can be either paper-based or electronic. In present years, electronic CRFs are most popular. It is because they possess improved data quality, online discrepancy management, and database lock facilities. The main purpose of CRF development is to preserve and maintain the quality and integrity of data. It is designed in a manner that suits all users e.g., investigator, site coordinator, study monitor, data entry personnel, medical coder, and statistician. CRF design is guided by standard guidelines. The site personnel who is responsible for data entry are provided with CRF completion manual to ensure the accuracy in the data entry. It is an initial step in translating the protocol into standard questionnaires and is of high importance for conducting any clinical trial. It is designed in a way that allows collection of consistent and verified data to submit to health authorities. The consistency of data collection is very important for analysing the inherent meaning of the data collected. The data collected in a CRF is strictly restricted to that required in a protocol. The design of a CRF may vary between Clinical Research Organizations, Clinical Research Associates and Data Managers. Every CRF is reviewed by an interdisciplinary review board.
Design of a Case report form (CRF)
The components of a good CRF consists a header, safety modules and efficacy modules. The header contains the study number, site no and participant ID no. whereas the safety modules represent the demographic information, adverse events, medical history, physical exam, deaths, drop-outs, and eligibility confirmation. Finally, the efficacy module is strictly guided by the protocol which primarily includes the key efficacy endpoints of trial, additional tests to measure efficacy, how lesions will be measured and requited diagnostics.
The basic design of a standard case report form follows a consistent format, font style and sizes that should be maintained throughout the document. In a document, either of the layouts either portrait or landscape can be used but never both. All the sections must address a clear and concise questions, prompts and instructions. A good CRF design consist of visual cues for indicating the place and format of data. These visual cues provided with check boxes are advised. Other points like including page numbers separating the columns with thick lines and providing bold and italicized instructions with clarity are commonly practiced while designing a good quality CRFs.
CRF connectivity or linking is very crucial during the data collection and subsequent statistical analysis especially when statistical analysis plan (SAP) is complex. To prevent missing of CRF pages, every CRF must be connected or linked with a unique subject ID that will help in tracking in case the pages are missed. The site personnel is responsible for keeping track of the fact that every CRF contains its assigned CRF ID. Other fields such as protocol ID, CRF version numbers, site code, subject ID, and patient initials also helps in providing brief descriptions of the study. Furthermore, page numbering also helps in providing quick reference to the specific pages and allows database design in structured manner.
CRF Completion Guidelines
Once the CRF has been designed and it reaches the site, the site personnel must be provided with a CRF completion guidelines which will enable the investigator to complete the CRF. Therefore, a CRF completion guideline is another document that helps the investigator or site personnel to complete the CRF with ease and legibility. The CRF completion guidelines is study specific and so does not have any standard template. Like any other document the language of the guideline should be simple, clear comprehensible and concise.
Very often, the data requirements or fields of demography, adverse events etc., are same. Therefore, many sponsor/contract research organizations and pharmaceutical companies maintain a library of templates which can be simultaneously used in multiple studies of similar research domain. These templates are similar in design and separate completion guidelines are not required usually.
Conclusion
Case report form is an important data collection tool and designing it is a tricky process. The design of a CRF depends on the type of clinical trial study. It should include all the fields that are required for meaningful and accurate interpretation of the clinical study being conducted. Furthermore, its pages must be connected or linked in such a way that the missing pages can be tracked back easily. The CRF is provided to the site personnel along with a CRF completion guidelines for data collection.
References
Bellary S, Krishnankutty B, Latha MS. Basics of case report form designing in clinical research. Perspect Clin Res. 2014 Oct;5(4):159-66. doi: 10.4103/2229-3485.140555. PMID: 25276625; PMCID: PMC4170533.
ICH Guidance E6: Good Clinical Practice: Consolidated guideline. US HHS, US FDA, CDER, CBER. 1996. Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf.
Student Name: Dr Pragya Prasanna
Student ID: CSRPL_STD_IND_HYD_ONL/CLS_187/092023
Qualification: PhD
e-Mail ID: prasannapragya2@gmail.com
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