Paper-based clinical research studies statistics

Background Collection of individual patient data on Case Report Forms CRFs in clinical research has traditionally been done by investigators in their offices summarizing medical charts on paper forms pCRFs , a tedious method that could result in data errors and wrong conclusions [ 1 , 2 ]. Methods The primary endpoint was the satisfaction of stakeholders in a clinical study: investigators, clinical research associates CRAs and data managers DMs. Material Clinical studies: inclusion criteria We retrospectively selected biomedical research studies monitored by 6 research units involved in eCRF testing, completed between and or for eCRFs and sponsored by the Paris regional hospital consortium AP-HP.

Stakeholders We investigated the satisfaction and preference of three stakeholder groups: investigators, clinical research associates CRAs and data managers DMs for both types of CRF. Methods Clinical studies We collected protocols, budgets and expense statements, CRFs, monitoring reports and other relevant technical documents. Cost estimation The cost of a study was estimated from: labor costs, i. Statistical analysis Clinical studies The unit of analysis was the study. Open in a separate window. Clinical studies Time from the opening of the first center to database lock tended to be shorter with eCRFs SE: standard error.

Figure 1.

IPPCR 2016: Data Management & Case Report Form Development in Clinical Trials

Figure 2. Table 4 Characteristics of the respondents to the satisfaction and preference surveys. Figure 3.

Figure 4. Responses from investigators, clinical research associates and data managers. CRA: clinical research associate, DM: data manager.

Table 6 Main themes discussed by stakeholders in open-ended questions. Answers from investigators, clinical research associates and data managers. Discussion In this first description of the use of eCRFs and pCRFs across 27 clinical studies, we found that most stakeholders were satisfied with eCRFs and that the use of eCRFs was associated with shorter study duration and lower cost per patient. Endnote a CDISC: standards of acquisition, exchange, submission and archive of clinical research data that enable information system interoperability to improve medical research. Competing interests The authors declare that they have no competing interests.

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Additional file 2: Satisfaction questionnaire addressed to investigators. Click here for file K, doc. Additional file 3: Satisfaction questionnaire addressed to clinical research associates. Additional file 4: Satisfaction questionnaire addressed to data managers. Double data entry: what value, what price?

Control Clin Trials. Quantifying data quality for clinical trials using electronic data capture. The use of electronic data capture tools in clinical trials: Web-survey of Canadian trials. J Med Internet Res. Is the future for clinical trials internet-based? A cluster randomized clinical trial. Clin Trials. Data capture by digital pen in clinical trials: a qualitative and quantitative study.

Contemp Clin Trials. Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy. BMC Musculoskelet Disord. J Am Med Inform Assoc. A comparative study of mobile electronic data entry systems for clinical trials data collection. Int J Med Inform. Informatics tools to improve clinical research study implementation. Data collection outcomes comparing paper forms with PDA forms in an office-based patient survey.

Ann Fam Med. Concept and implementation of a computer-based reminder system to increase completeness in clinical documentation. Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study. Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies—the Pre-Optimon study.

The Internet and clinical trials: background, online resources, examples and issues. Use of the world wide web in research: randomization in a multicenter clinical trial of treatment for twin-twin transfusion syndrome. Obstet Gynecol. Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study. Validating electronic source data in clinical trials. Internet based multi-institutional clinical research: a convenient and secure option. J Urol. Internet in clinical research based on a pilot experience.

In-Depth: The rise of the digital clinical trial

Implementation of electronic data capture systems: barriers and solutions. Physicians, patients, and the electronic health record: an ethnographic analysis. No paper, but the same routines: a qualitative exploration of experiences in two Norwegian hospitals deprived of the paper based medical record. Analysis of cost data in randomized trials: an application of the non-parametric bootstrap.

Stat Med. Paradigm shifts in clinical trials enabled by information technology. A comparison study: paper-based versus web-based data collection and management. Appl Nurs Res. Comparison of electronic data capture with paper data collection — Is there really an advantage?

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Putting patients first – e-consent in clinical trials

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Median planned duration of study months. Median planned patient follow up days. Median number of variables in CRF. Number of patients included. Planned duration of study. Duration of the study:. Cost of the study log :. Trial without randomization. Trial with randomization. Non-interventional study.

Clinical trial monitoring – the present and the future |

Computer proficiency level. Fast, simple, without bugs and blocking, with flexible data entry. Reliable data collection, with few queries x8.