Abstract

Aim: The aim of our research was to design and implement data collection instruments to be use in context of an observational prospective clinical study with follow-up conducted on new born with intrauterine growth restriction. Methods: The structure of the data collection forms (paper based and electronic based) was first identified and for each variable the best type to accomplish the research aim was established. The code for categorical variables has also been decided as well as the units of measurements for quantitative variables. In respect of good practice, a set of confounding factors (as gender, date of birth, etc.) have also been identified and integrated in data collection instruments. Data-entry validation rules were implemented for each variable to reduce data input errors when the electronic data collection instrument was created. Results: Two data collection instruments have been developed and successfully implemented: a paper-based form and an electronic data collection instrument. The developed forms included demographics, neonatal complications (as hypoglycemia, hypocalcemia, etc.), biochemical data at birth and follow-up, immunological data, as well as basal and follow-up echocardiographic data. Data-entry validation criteria have been implemented in electronic data collection instrument to assure validity and precision when paper-based data are translated in electronic form. Furthermore, to assure subject’s confidentiality a careful attention was given to HIPPA identifiers when electronic data collection instrument was developed. Conclusion: Data collection instruments were successfully developed and implemented as an a priori step in a clinical research for assisting data collection and management in a case of an observational prospective study with follow-up visits.

Keywords

paper Case Report Form (pCRF), Electronic Data Collection Instrument (EDCI), Data-Entry Validation, Observational Study, Clinical Research