Verified Document

Attributes Of A Well-Designed Case Report Form Essay

Attributes of a Well-Designed case report form Well- Referenced

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 non-time dependent data....

The layout of the CRF design should be finalized after considering data review time, frequency, and also the CRF clustered level (Moon, 2006).
Non-time dependent data: 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…

Sources used in this document:
Bibliography

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.
Cite this Document:
Copy Bibliography Citation

Related Documents

Dirt Bikes Case Study Analytics
Words: 4458 Length: 12 Document Type: Essay

Case Study Two: Developing a Disaster Recovery Plan The greatest threats to Dirt Bike's systems today have to do with taking a minimal, low-cost approach to enterprise system security, leaving large areas of their system platform vulnerable to competitors and hackers to steal their sales, finance and product design data. The second most likely threat they face is having their systems hacked into by disgruntled employees, who are seeking to get

Metadata Repository Is a Database
Words: 2157 Length: 8 Document Type: Research Paper

An architect could also choose a Metamodel, which specify the elements of the model to be stored. 7 Select Modeling Levels to be Stored within the Repository An Architect should select the modeling levels, which include source code, models, runnable code and model instances to be stored in a Metadata Repository, Model Repository or a Model. 8 Select Metadata Types With reference to the Metadata Repository, a Model to be used, an architect could select

Information Systems Multi-Chapter Case Study
Words: 3615 Length: 13 Document Type: Case Study

First, as Personal Trainer expands globally, the system will be available through web browsers anywhere in the world. Second, the ease of completing system upgrades across all users at the same time needs to be taken into consideration, and the use of the Web-based system architecture hosted on a Software-as-a-Service (SaaS) platform is critical. Third, by taking this approach Susan can b e assured there will be higher levels

Impact Assessment of Eia Report
Words: 2386 Length: 8 Document Type: Essay

EIA Report The project in question that of Building a reduced-sulfur generating, coal-fired plant by GHECO-One in Map Ta Phut, Thailand was examined for potential environmental impact due to the possible damage that the plant could cause. The company has stated throughout that their wish is to construct a plant that will be both environmentally and physically safe for the people, plants and animals that live within the region. This

Diabetes Mellitus in This Report,
Words: 5199 Length: 19 Document Type: Term Paper

Some patients feel helpless, hopeless, depressed, isolated from others, belittled, and do not know how to seek appropriate help from others (Rutter 2004). Socially supportive arrangements were addressed as the attributes of socially legitimate roles which provide for the meeting dependency needs without loss of esteem. Socially supportive environments were presented as pattern interpersonal relationships mediated through shared values and sentiments as well as facilitate the performance of social

Individual Business Report You Required Select Organisation
Words: 2471 Length: 8 Document Type: Essay

Individual Business Report You required select organisation choice. This organisation work, worked past organisation access information. Supply Chain Management In its most basic connotation, supply chain implies the movement of goods from the raw materials stage through to the customer. Entirely all organizations across the world have some level of supply chain processes within themselves that accounts for the delivery of goods and services to satisfy the customer demands. The length

Sign Up for Unlimited Study Help

Our semester plans gives you unlimited, unrestricted access to our entire library of resources —writing tools, guides, example essays, tutorials, class notes, and more.

Get Started Now