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 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.
Click here for file 12K, xlsx.
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?
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In-Depth: The rise of the digital clinical trial
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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.