Attributes of a Well-Designed
An informative footer and header are some of the components of a case report form (CRF) that is well-referenced. A good footer or header contains information such as page number, date of printing, subject initials, subject ID, protocol number and sponsor ID. These pieces of information identify the CRF page in a unique manner.
All the CRF booklet’s pages ought to be numbered sequentially. This assists in the identification of manual review and data validation queries. Where there is just a single cumulative log page or unscheduled assessment being printed, one can insert a sequence number in the footer so that the pages being photocopied can easily be sequentially identified. A CRF that is well designed in the case of data collection in a laboratory would capture all the essential parameters linking to the central laboratory. Where the study takes place in more than one center, a central lab can be made use of for analysis of samples and preparation of results in a data set that is ready for analysis. This ensures that transcription errors are minimized and the quality of the data maintained.
CRF Design Layout
At least three types of data exist: cumulative data, time-dependent data, and . The layout of the CRF design should be finalized after considering data review time, frequency, and also the CRF clustered level (Moon, 2006).
: this is the kind of data that has been gathered at one point in time. Data like this includes medical history and demographics.
Time-dependent data: this is data that has been collected over a period of time. A good example of time-dependent data would be vital signs for an individual patient that have been recorded over several visits.
Cumulative data: this is data that has been collected over a period of time, without linkage to any particular visit. A good example is concomitant medications (Moon, 2006).
Organizing CRF Fields
CRF fields that are superbly structured and aligned give a clearer direction for the collection of data as well as for annotation of CRFs (Moon, 2006).
CRF Field Designs
CRFs that are well designed make use of different kinds of icons for various response formats. This is helpful in achieving data format consistency. They give a good picture of what investigators are expected to achieve and assists in ensuring that the data reported is valid (Moon, 2006).
CRF Completion Guidelines
These guidelines can be included so as to give procedures of data collection that are specific to the study in question. These guidelines help in bridging the gap that might exist between the users of the data and the study protocol (Moon, 2006).
Discuss how a poorly designed case report form can affect both data input and data output in a clinical trial
A protocol that has been designed well and articulated properly is one tool that is highly important in terms of ensuring that the data is of high quality. An ambiguous or poorly designed protocol may result in systemic errors that render the investigation very unreliable. Further, data quality can be influenced by how complex the trial design is and the volume of data to be collected (DHHS, 2013). A will result in the database being frequently modified; the timelines of the study will be consequently affected. The collection of data should be unbiased and error free. Collecting huge volumes of data wastes resources in both data collection and processing. The aim should be to achieve clarity and do away with ambiguity (Bellary, Krishnankutty & Latha, 2014).
CRFs that are not properly designed will definitely cause deficiencies such as collection of unnecessary data, data not being collected according to protocol, impediments in the process of data entry, and modifications to the database in the course of the study (CCRNCI, n.d.). Bias and lack of precision are some of the main shortcomings fueled by poor CRF design that are impossible to correct after the trial has been carried out. Even the best statistical analysis cannot compensate for poor design.
According to Piantadosi (2005), the following are the benefits of having a good design:
Investigators are allowed to satisfy ethical constraints
Good design leads to limited resources being efficiently utilized
The treatment effect is isolated from the cofounders’ interests
Precision is controlled
Observer bias and selection bias are drastically reduced
Uncertainty or random errors are minimized and quantified
The analysis is simplified and validated
The external validity of the trial is increased (Clinical Trial Designs, n.d.).
Bellary, S., Krishnankutty, B., & Latha, M. (2014). Basics of case report form designing in clinical research. NCBI, 159-166.
CCRNCI. (n.d.). Clinical Data Management. Retrieved from crrod.cancer.gov: https://ccrod.cancer.gov/confluence/download/attachments/71041052/CDM.pdf
Clinical Trial Designs. (n.d.). Retrieved from onlinecourses.science.psu.edu: https://onlinecourses.science.psu.edu/stat509/book/export/html/18
DHHS. (2013). Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring. U.S. Department of Health and Human Services Food and Drug Administration.
Moon, K.-h. K. (2006). Techniques for Designing Case Report Forms in Clinical Trials. ScianNews, 1-7.
Piantadosi Steven. (2005) Clinical Trials as Experimental Designs, Random Error and Bias, Objectives and Outcomes, Translational Clinical Trials, Dose-Finding Designs. In: Piantadosi Steven. Clinical Trials: A Methodologic Perspective. 2nd ed. Hobaken, NJ: John Wiley and Sons, Inc.