Web-Based Case Report Form Design for Clinical Trial

2010 ◽  
Vol 39 ◽  
pp. 19-24 ◽  
Author(s):  
Ling Li Fu ◽  
Tao Chen
Keyword(s):  
Clinical Trials ◽  
Case Report ◽  
Web Application ◽  
New Drugs ◽  
Case Report Form ◽  
Web Based ◽  
Electronic Application ◽  
Form Design ◽  
Near Future ◽  
Cdisc Odm

With more clinical trials using electronic way, new drugs electronic application has becoming an inevitable trend in near future. A well-designed case report form (CRF) is the premise of high quality clinical trials which facilitates data collection and entry, and directly benefits other facets of clinical data management. Firstly, paper introduces the CRF design modes and design principles. Then paper describes the CRF design process, and based on this, paper constructs the data structure with CDISC ODM concept. Lastly, paper explores how to convert the paper CRF to electronic format in web application with SAS statistic requirements in detail.

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study

10.2196/14744 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14744
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

Background Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. Objective This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. Methods In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. Results The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. Conclusions The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. International Registered Report Identifier (IRRID) PRR1-10.2196/14744

scholarly journals Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy

Vaccine ◽  
2016 ◽  
Vol 34 (49) ◽  
pp. 6007-6014 ◽  
Author(s):  
Christine E. Jones ◽  
Flor M. Munoz ◽  
Sonali Kochhar ◽  
Stefania Vergnano ◽  
Clare L. Cutland ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Case Report ◽  
Case Report Form ◽  
In Pregnancy

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study (Preprint)

2019 ◽  
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

BACKGROUND Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. OBJECTIVE This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. METHODS In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. RESULTS The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. CONCLUSIONS The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14744

scholarly journals Design and virtual implementation of a biomedical registry framework for the enhancement of clinical trials: colorectal cancer example

2019 ◽  
Vol 26 (1) ◽  
pp. e100008 ◽  
Author(s):  
Athanasios Kotoulas ◽  
George Lambrou ◽  
Dimitrios-Dionysios Koutsouris
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Web Application ◽  
Molecular Data ◽  
Open Science ◽  
Direct Access ◽  
Biomedical Data ◽  
Web Based ◽  
Initial Clinical Trial ◽  
Local Host

IntroductionClinical trials generate a large volume of literature and a vast amount of data. Following the 'open science' model, data sharing has enormous potential to strengthen scientific research. Currently, to the best of our knowledge, there is no existing web based Hellenic biomedical registry that displays available patients for clinical trials, providing direct access to registered physicians to all data, assisting them in finding eligible patients in the initial clinical trial recruitment process.MethodsThis paper describes the design and virtual implementation of a web based prototype biomedical registry in Greece. The system represents an eGovernment framework proposal for the central storage of patients' biomedical information and the operations associated with this process. The increasing tendency to include molecular data as prerequisite elements in clinical trials is adopted in the registry philosophy. The designed system is based on free, open source software and it is implemented virtually on a local host environment.ResultsUsing colorectal cancer as an example, valid data from patients increases the reliability index, demonstrating the functionality of the web application.ConclusionIn conclusion, the combination of biomedical data and information technology in order to display potential participants per health unit, facilitates recruitment for clinical trials.

scholarly journals Accrual Prediction Program: A web-based clinical trials tool for monitoring and predicting accrual for early-phase cancer studies

2019 ◽  
Vol 16 (6) ◽  
pp. 657-664 ◽  
Author(s):  
Junhao Liu ◽  
Jo A Wick ◽  
Dinesh Pal Mudaranthakam ◽  
Yu Jiang ◽  
Matthew S Mayo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real Time ◽  
Web Application ◽  
Time Trial ◽  
Cancer Center ◽  
University Of Kansas ◽  
Web Based ◽  
Institutional Level ◽  
Prediction Program ◽  
The University

Background Monitoring subject recruitment is key to the success of a clinical trial. Accordingly, researchers have developed accrual-monitoring tools to support the design and conduct of trials. At an institutional level, delays in identifying studies with high risk of accrual failure can lead to inefficient and costly trials with little chances of meeting study objectives. Comprehensive accrual monitoring is necessary to the success of the research enterprise. Methods This article describes the design and implementation of the University of Kansas Cancer Center Accrual Prediction Program, a web-based platform was developed to support comprehensive accrual monitoring and prediction for all active clinical trials. The Accrual Prediction Program provides information on accrual, including the predicted completion date, predicted number of accrued subjects during the pre-specified accrual period, and the probability of achieving accrual targets. It relies on a Bayesian accrual prediction model to combine protocol information with real-time trial enrollment data and disseminates results via web application. Results First released in 2016, the Accrual Prediction Program summarizes enrollment information for active studies categorized by various trial attributes. The web application supports real-time evidence-based decision making for strategic resource allocation and study management of over 120 ongoing clinical trials at the University of Kansas Cancer Center. Conclusion The Accrual Prediction Program makes accessing comprehensive accrual information manageable at an institutional level. Cancer centers or even entire institutions can reproduce the Accrual Prediction Program to achieve real-time comprehensive monitoring and prediction of subject accrual to aid investigators and administrators in the design, conduct, and management of clinical trials.

ANALYZING AND IMPROVING WEB APPLICATION QUALITY USING DESIGN PATTERNS

2012 ◽  
Vol 2 (2) ◽  
pp. 112-116
Author(s):  
Shikha Bhatia ◽  
Mr. Harshpreet Singh
Keyword(s):  
Web Application ◽  
Design Pattern ◽  
Design Patterns ◽  
Web Applications ◽  
Past Research ◽  
Software Systems ◽  
Interactive Software ◽  
Web Based ◽  
Software Application ◽  
Execution Speed

With the mounting demand of web applications, a number of issues allied to its quality have came in existence. In the meadow of web applications, it is very thorny to develop high quality web applications. A design pattern is a general repeatable solution to a generally stirring problem in software design. It should be noted that design pattern is not a finished product that can be directly transformed into source code. Rather design pattern is a depiction or template that describes how to find solution of a problem that can be used in many different situations. Past research has shown that design patterns greatly improved the execution speed of a software application. Design pattern are classified as creational design patterns, structural design pattern, behavioral design pattern, etc. MVC design pattern is very productive for architecting interactive software systems and web applications. This design pattern is partition-independent, because it is expressed in terms of an interactive application running in a single address space. We will design and analyze an algorithm by using MVC approach to improve the performance of web based application. The objective of our study will be to reduce one of the major object oriented features i.e. coupling between model and view segments of web based application. The implementation for the same will be done in by using .NET framework.

eMap: A Web Application for Identifying and Visualizing Electron or Hole Hopping Pathways in Proteins

2019 ◽  
Author(s):  
Ruslan N. Tazhigulov ◽  
James R. Gayvert ◽  
Melissa Wei ◽  
Ksenia B. Bravaya
Keyword(s):  
Web Application ◽  
Shortest Paths ◽  
Coarse Grained ◽  
Decay Parameter ◽  
Electron Hole ◽  
Web Based ◽  
Aromatic Amino Acid Residue ◽  
Pathways Model ◽  
Visualization Tools ◽  
Effective Decay

<p>eMap is a web-based platform for identifying and visualizing electron or hole transfer pathways in proteins based on their crystal structures. The underlying model can be viewed as a coarse-grained version of the Pathways model, where each tunneling step between hopping sites represented by electron transfer active (ETA) moieties is described with one effective decay parameter that describes protein-mediated tunneling. ETA moieties include aromatic amino acid residue side chains and aromatic fragments of cofactors that are automatically detected, and, in addition, electron/hole residing sites that can be specified by the users. The software searches for the shortest paths connecting the user-specified electron/hole source to either all surface-exposed ETA residues or to the user-specified target. The identified pathways are ranked based on their length. The pathways are visualized in 2D as a graph, in which each node represents an ETA site, and in 3D using available protein visualization tools. Here, we present the capability and user interface of eMap 1.0, which is available at https://emap.bu.edu.</p>

Improving vaccine uptake: a new uptake reporting tool

2018 ◽  
Vol 68 (suppl 1) ◽  
pp. bjgp18X697205
Author(s):  
Elise Tessier ◽  
Richard Pebody ◽  
Nicki Boddington ◽  
Michael Edelstein ◽  
Joanne White ◽  
...  
Keyword(s):  
Reporting System ◽  
Influenza Season ◽  
Vaccine Uptake ◽  
Web Based ◽  
Current Season ◽  
Previous Season ◽  
Uptake Rates ◽  
Reporting Tool ◽  
Uptake Data ◽  
Near Future

BackgroundVaccine uptake data is automatically extracted from all GP practices in England via the web-based reporting system, ImmForm, on behalf of Public Health England. In 2016/17, an Uptake Summary Tool was introduced on ImmForm for practice managers, clinical commissioning groups (CCGs) and screening and immunisation teams (SCRIMMS) to help facilitate local and regional management of the influenza programme. The tool allows practices to view and evaluate influenza uptake rates by target cohorts, comparing them against the previous season and CCG average/overall national uptake each week.AimTo assess how many practices use the Uptake Summary Tool and whether there is a difference in vaccine uptake among practices that use the tool compared with those that don’t during the 2016/17 and 2017/18 influenza seasons.MethodPractice level use of the Uptake Summary Tool was examined for the 2016/17 influenza season and vaccine uptake compared between practices that used the tool and those that did not.ResultsAn average of 1272 practices used the tool each week during the 2016/17. Vaccine uptake was on average 2.9% greater for targeted cohorts in practices that used the tool than practices that did not during the 2016/17 season.ConclusionWhen used on a regular basis the Uptake Summary Tool can help GP practices, CCGs and SCRIMMS monitor vaccine and may be associated with increased vaccine uptake. Uptake for the 2017/18 season will be monitored and assessed throughout the current season. We aim to expand the tool to other vaccine collections in the near future.

Sign in / Sign up

Export Citation Format

Share Document