A multidisciplinary-guided digital solution to data capture in early-phase clinical trials.

e18063 Background: Data capture in early phase cancer clinical trials (EPCCT) is usually via paper records with manual transcription to the sponsor’s case report form. Capturing real time trial data directly to computer (eSource) may reduce errors and increase completeness and timeliness of data entry. A simulated system pilot took place between Oct 2018 and Jan 2019 at an EPCCT facility to appraise Foundry Health’s eSource system “ClinSpark”. Aims were to assess consistency and effectiveness of creating electronic templates for source data capture and live data collection compliance. Methods: A multidisciplinary focus group (2 research nurses, 1 doctor, 3 data managers) was created to collaborate with Foundry Health staff. The focus group agreed on a 52 item user acceptance test listing ideal features for a data collection tool, classifying items as high, medium or low priority. Specialised features of the eSource system were adapted to handle the complex needs of EPCCT. The pilot incorporated a 5 day boot camp for familiarisation to the digital platform; a conference room test using simulated patient data; construction of a trial template including contingency planning; and a clinic floor test with live simulated patient data collection using digital tablets. Results: During the 3 month pilot, templates for 2 EPCCT were planned and created. Using eSource, 43 items (83%) of the acceptance test were passed compared with 27 items (52%) for the current (paper-based) system. The paper system did not pass any of the 9 items for which eSource failed. For the 30 high priority items, eSource passed 30 (100%) compared with 22 for the paper system (73%). Time saving and potential error reduction were noted as additional benefits. Conclusions: This process demonstrates that a multidisciplinary approach can be used to successfully integrate a customised eSource system working with previously untrained staff. Improved performance across pre-specified domains and potential additional benefits were noted. As FDA encourages the use of digital solutions in clinical trials, using eSource provides a potential solution for compliant and efficient capture of data from protocol assessments at investigator sites and rapid data transfer to sponsors.

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A multidisciplinary-tailored digital solution to data capture in early phase clinical trials.

Journal of Global Oncology ◽

10.1200/jgo.2019.5.suppl.2 ◽

2019 ◽

Vol 5 (suppl) ◽

pp. 2-2

Author(s):

Donna M. Graham ◽

Gemma Wickert ◽

Leanna Goodwin ◽

Joanna Clarke ◽

Carla Timmins ◽

...

Keyword(s):

Clinical Trials ◽

Data Collection ◽

Early Phase ◽

Patient Data ◽

Simulated Patient ◽

Data Capture ◽

Health Staff ◽

Case Report Form ◽

Acceptance Test ◽

Time Saving

2 Background: Data capture in early phase cancer clinical trials (EPCCT) is usually via paper records with manual transcription to the sponsor’s case report form. Capturing real time trial data directly to computer (eSource) may reduce errors and increase completeness and timeliness of data entry. A simulated system pilot took place between Oct 2018 and Jan 2019 at an EPCCT facility to appraise Foundry Health’s eSource system “ClinSpark”. Aims were to assess consistency and effectiveness of creating electronic templates for source data capture and live data collection compliance. Methods: A multidisciplinary focus group (MFG) (2 research nurses, 1 doctor, 3 data managers) was created to collaborate with Foundry Health staff. Specialised features of the eSource system were adapted to handle the complex needs of EPCCT. The pilot incorporated a 5 day boot camp for familiarisation to the digital platform; a conference room test using simulated patient data; construction of a trial template including contingency planning; and a clinic floor test with live simulated patient data collection using digital tablets. The MFG agreed on a 52 item user acceptance test listing ideal features for a data collection tool, with items classified as high, medium or low priority. Results: During the 3 month pilot, templates for 2 EPCCT were planned and created by the MFG. Using eSource, 43 items (83%) of the acceptance test were passed compared with 27 items (52%) for the current (paper) system. For the 30 high-priority items, eSource passed 30 (100%) compared with 22 for the paper system (73%). The paper system was not superior to eSource for any items assessed. Time saving and potential error reduction were noted as additional benefits. Conclusions: This process demonstrates that a multidisciplinary approach can be used to successfully integrate a customised eSource system working with previously untrained staff. Improved performance across pre-specified domains and potential additional benefits were noted. As FDA encourages use of digital solutions in clinical trials, using eSource provides a potential solution for compliant and efficient data capture from protocol assessments at investigator sites and rapid data transfer to sponsors.

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The experience of the clinical trial center at Alessandria Hospital regarding the activation of COVID-19 clinical trials during the pandemic

Working Paper of Public Health ◽

10.4081/wpph.2020.9248 ◽

2021 ◽

Vol 8 (1) ◽

Author(s):

Annalisa Roveta ◽

Fabio Giacchero ◽

Carolina Pelazza ◽

Serena Penpa ◽

Costanza Massarino ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Data Collection ◽

Clinical Research ◽

Fast Track ◽

Data Capture ◽

Electronic Data Capture ◽

Electronic Data ◽

Web Based ◽

Taking Charge

Objective: The aim is to evaluate the speed in the activation of Covid-19 clinical trials at SS. Antonio e Biagio e Cesare Arrigo Hospital of Alessandria during the pandemic. Methods: Data collection related to the activation and the conduction of clinical trials was managed using a database created through a web-based platform REDCap (Research Electronic Data Capture). Results: 32 studies were activated in the period between March 23 and July 31, 2020. An average time of 14 days elapsed between taking charge of the request and the issuance of the authorization act. Conclusions: During the emergency it was possible to activate the trials quickly thanks to fast-track procedures, optimizing COVID-19 clinical research.

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The Prostate Cancer Clinical Trials Consortium (PCCTC) bone scan data capture tool for clinical trials using Prostate Cancer Working Group 2 (PCWG2) criteria: Effect on data accuracy and workload.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.7_suppl.121 ◽

2011 ◽

Vol 29 (7_suppl) ◽

pp. 121-121 ◽

Cited By ~ 2

Author(s):

M. J. Morris ◽

J. S. Farrelly ◽

J. J. Fox ◽

E. R. Dennis ◽

L. H. Schwartz ◽

...

Keyword(s):

Prostate Cancer ◽

Clinical Trials ◽

Radiographic Progression ◽

Data Capture ◽

Phase Iii ◽

Cancer Center ◽

Case Report Form ◽

Imaging Data ◽

Electronic Data Capture System ◽

The Impact

121 Background: PCWG2 Concensus Criteria proposed time-to-event endpoints in early phase clinical trials. Chief among these was time to radiographic progression for bone scintigraphy (BS), based on a standardized definition with additional rulesets to account for early flare. The PCCTC created a tool to operationalize these definitions in clinical trials. We tested the impact of the tool on clinical trial workload and data adequacy. Methods: The BS capture tool was vetted and amended through nine versions by a multidisciplinary group from PCCTC participating institutions. Accruals at Memorial Sloan-Kettering Cancer Center on two phase III trials using the same drug, contracting research organization (CRO), and electronic data capture system were analyzed. The first trial did not use the PCCTC tool. The second incorporated the tool in its data collection plan and case report form. Workload and data capture adequacy for each trial were determine by examining the total number of imaging queries from the database query reports obtained from the CRO as a function of the total number of scans and patients. Results: Data from this analysis are found in the table . The relative number of queries per scan was reduced by 85.33% by use of the tool. The queries:scan ratios were 0.82 versus 0.12 before and after the use of the tool respectively; likewise, the ratios of queries: patient were 2.81 vs. 0.44. Conclusions: Using the PCCTC BS tool to standardize data capture and operationalize PCWG2 radiographic progression criteria, imaging data are more completely reported and workload for study research staff decreased. The reproducibility and feasibility of the BS tool is further being tested in two ongoing phase III studies in which PCWG2 criteria are being clinically qualified. These efforts to quantitate, standardize, and qualify imaging data advance the goal of developing an imaging biomarker in metastatic prostate cancer. [Table: see text] No significant financial relationships to disclose.

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Experience with digital entry of national iodine survey data in Senegal

African Journal of Food, Agriculture, Nutrition and Development ◽

10.18697/ajfand.55.11145 ◽

2012 ◽

Vol 12 (55) ◽

pp. 6987-7000

Author(s):

K Siekmans ◽

◽

I Ngnié-Teta ◽

B Ndiaye ◽

P Bert ◽

...

Keyword(s):

Data Collection ◽

Survey Data ◽

Handheld Computers ◽

Data Capture ◽

Quality Data ◽

Personal Digital Assistants ◽

Health Staff ◽

Time Data ◽

Quality Of Data ◽

Direct Data

There is growing evidence and enthusiasm for the use of technology to enhance accuracy and speed and minimize the costs of quantitative data surveys. Handheld computers have the potential to facilitate high quality data collection and timely analysis for large complex surveys in developing country contexts. The objective of this paper is to document the experience of using handheld computers for direct data capture in a national survey to monitor progress toward universal salt iodization in Senegal. Twenty-five personal digital assistants (PDAs) were programmed and used by five teams across 13 regions for entering data from 3768 households over a period of three weeks. The health staff selected to collect the data learned how to manipulate the PDAs within a short amount of time. The PDAs contributed to improved quality of data collection due to automatic skipping of non-applicable questions and selection of individuals eligible for goitre assessment. The PDAs also were programmed to randomly select one woman and one school-age child within each household for biochemical sample collection. Data on geographic locations were collected for 82% of households surveyed using the PDA’s in-built Global Positioning System (GPS) functionality, which showed the geographical dispersion of these households and which will be used for analysis of results for key indicators by location. Problems with household selection processes, identification coding and standardized interview methods were observed. While costs for printing questionnaires and manual data entry were saved, significant costs were incurred for PDA technical support by an international consultant. The use of PDAs significantly reduced data processing time. Data were stored and downloaded to a central database, with the full dataset and preliminary results available to stakeholders within one week following the survey completion. The PDAs are an excellent tool for enhancing capacity to collect complex household survey data and make it available for analysis in a timely manner. Quality training and adequate pre-testing of questionnaires are still essential. Increased use of direct data capture methods in health program design, monitoring and evaluation is recommended, along with efforts to build local technical capacity.

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The Launch of the "Overcoming the Barriers To Early Phase Clinical Trials" Program

PsycEXTRA Dataset ◽

10.1037/e369592004-001 ◽

2002 ◽

Author(s):

Keyword(s):

Clinical Trials ◽

Early Phase ◽

Early Phase Clinical Trials

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Management Strategy for Distributing Questionnaires and Interview Guidelines in the Research Data Collection Process

Aptisi Transactions on Management (ATM) ◽

10.33050/atm.v2i2.802 ◽

2018 ◽

Vol 2 (2) ◽

pp. 104-111

Author(s):

Po. Abas Sunarya ◽

George Iwan Marantika ◽

Adam Faturahman

Keyword(s):

Focus Group ◽

Data Collection ◽

Management Strategy ◽

Research Data ◽

Accurate Information ◽

Focus Group Interviews ◽

Good Management ◽

Research Activities ◽

Data Collection Process ◽

Group Interviews

Writing can mean lowering or describing graphic symbols that describe a languageunderstood by someone. For a researcher, management of research preparation is a veryimportant step because this step greatly determines the success or failure of all researchactivities. Before a person starts with research activities, he must make a written plan commonlyreferred to as the management of research data collection. In the process of collecting researchdata, of course we can do the management of questionnaires as well as the preparation ofinterview guidelines to disseminate and obtain accurate information. With the arrangement ofplanning and conducting interviews: the ethics of conducting interviews, the advantages anddisadvantages of interviews, the formulation of interview questions, the schedule of interviews,group and focus group interviews, interviews using recording devices, and interview bias.making a questionnaire must be designed with very good management by giving to theinformation needed, in accordance with the problem and all that does not cause problems at thestage of analysis and interpretation.

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Social Media Literacy For Housewives In Kanoman Maguwoharjo Village, Sleman, Yogyakarta

Proceeding of LPPM UPN "VETERAN" Yogyakarta Conference Series 2020- Political and Social Science Series ◽

10.31098/pss.v1i1.183 ◽

2020 ◽

Author(s):

Dewi Novianti ◽

Siti Fatonah

Keyword(s):

Social Media ◽

Focus Group ◽

Data Collection ◽

Focus Group Discussion ◽

Media Literacy ◽

Participant Observation ◽

Group Discussion ◽

Qualitative Approach ◽

Research Subjects

Social media is a necessity for everyone in communicating and exchanging information. Social media users do not know the boundaries of age, generation, gender, ethnicity, and religion. However, what is interesting is the user among housewives. This study took the research subjects of housewives. Housewives are chosen as research subjects because they are pillars or pillars in a household. If the pillar is strong, then the household will also be healthy. Thus, if we want to build a resilient and robust generation, we will start from the housewives. A healthy household starts from strong mothers too. This study aims to find out the insights of the housewives of Kanoman village regarding the content on smartphones and social media and provide knowledge of social media literacy to housewives. This study used a qualitative approach with data collection techniques using participant observation, interviews, focus group discussion (FGD), and documentation. The results of the study showed that previously housewives had not experienced social media literacy. Then the researchers took steps to be able to achieve the desired literacy results. Researchers took several steps to make them become social media literates. They become able to use social media, understand social media, and even produce messages through social media.

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