#HENRI POINTCARRE SOFTWARE#

We investigated the satisfaction and preference of three stakeholder groups: investigators, clinical research associates (CRAs) and data managers (DMs) for both types of CRF. Two studies which used pCRFs to collect data before entering it in the eCRF were analyzed in the eCRF group. Electronic (e) CRF studies used computer data entry by the investigator or an assistant, online or offline. Paper (p) CRF studies were defined by the use of a CRF on paper, completed with a pen, and data entry by a data clerk. The research topics were representative of the ongoing publicly funded clinical research. We retrospectively selected biomedical research studies monitored by 6 research units involved in eCRF testing, completed between 20 (or 2011 for eCRFs) and sponsored by the Paris regional hospital consortium AP-HP. Material Clinical studies: inclusion criteria Our hypotheses were that eCRFs save cost and time, and would be preferred by those 3 stakeholders. Secondary endpoints were costs and duration of the studies. The primary endpoint was the satisfaction of stakeholders in a clinical study: investigators, clinical research associates (CRAs) and data managers (DMs). Our objective was to formally describe the efficiency (measured by satisfaction, cost and duration of the study) of electronic and paper CRFs in the context of biomedical research conducted in hospitals. While some investigators have integrated the electronic interface into their medical practice to the point of making it an asset, the majority views the implementation of an eCRF in a paper-based working environment as a source of redundancy. The labor cost of data entry is transferred from clerks to investigators who may see few tangible benefits apart from a better quality of data and speedier study completion.

#HENRI POINTCARRE SOFTWARE#

Welker has identified some of the barriers to their dissemination: the lack of available on-site technology, insufficient assistance by Information Technologies staff or software providers, investigatorsвЂ™ lack of motivation and interference of eCRFs with their clinical tasks, complexity of installation and maintenance of the software and high investment cost. Дespite their demonstrated usefulness, eCRFs have not become dominant. Previous studies of eCRFs have primarily focused on the investigatorsвЂ™ point of view, while few have documented the perspectives of the other stakeholders. Moreover, use of eCRFs permits speedier database processing and shorter study periods, resulting in lower costs. Since the mid-1980s, eCRFs have increased data quality and completeness by using alarms, automatic completions and reminders, reducing losses and transport logistics, especially for multicenter trials. The feasibility of electronic CRFs (eCRFs) has been documented by numerous studies analyzing data collected on websites, laptops or digital pens. Electronic data capture has in recent years been increasingly used in both industry and academic research settings. The first ones are more advantageous in large, lowвЂ“risk studies and gain support from a majority of stakeholders.Д¬ollection 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. This study found that eCRFs and pCRFs are used in studies with different patient numbers, center numbers and risk. 15/72 for paper) for easier monitoring and improved data quality. Electronic CRFs were globally preferred by all (31/72 vs. Time between the opening of the first center and the database lock was 31.7 months Q1вЂ‰=вЂ‰24.6 Q3вЂ‰=вЂ‰42.8 using eCRFs, vs. The total cost per patient was 374в‚¬ в“51 with eCRFs vs. Mean costs and timeframes were compared using bootstrap methods, linear and logistic regression. Questionnaires were emailed to investigators of those studies, as well as clinical research associates and data managers working in Paris hospitals, soliciting their level of satisfaction and preferences for eCRFs and pCRFs. A total of 27 studies (11 eCRF, 16 pCRF) sponsored by the Paris hospital consortium, conducted and completed between 20 were included. Our objectives were to describe and contrast both objective and subjective efficiency of pCRF and eCRF use in clinical studies. Previous studies suggested that eCRFs avoided mistakes, shortened the duration of clinical studies and reduced data collection costs. Electronic Case Report Forms (eCRFs) are increasingly chosen by investigators and sponsors of clinical research instead of the traditional pen-and-paper data collection (pCRFs).

Henri pointcarre