Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium.
Ther Innov Regul Sci
; 53(4): 431-440, 2019 07.
Article
en En
| MEDLINE
| ID: mdl-30221997
ABSTRACT
Electronic capture of patient-reported outcome (PRO) data has many advantages over paper-based data collection. Regulatory agencies have consistently supported the use of electronic PRO (ePRO) data capture and recommended participant and site staff training on the correct use of electronic data capture systems. The objective of this paper is to outline best practice recommendations for training end users, including site staff and study participants, on the use of ePRO technology in clinical trials to enable consistent, accurate, and complete data collection. Site personnel should be trained on study-specific as well as technology-specific topics and be given instructions on whom to contact to obtain technical support. Optimal training takes place over time using multiple modalities, including hands-on, face-to-face training at an investigator meeting or directly in the clinical site; remote training via webinar or teleconference; interactive on-demand self-paced-training via e-learning modalities; and supplemented by proxy training performed by study clinical research associates. Like site personnel training, study participants should be provided with individual, hands-on training by site staff at the initiation of the trial and in conjunction with interactive electronic training modules that can be accessed on-demand throughout the duration of the trial. The recommendations put forth in this paper provide a structured framework for the training that site personnel and study participants need to optimize the advantages trials can gain from using ePRO data collection systems.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
/
2_ODS3
Problema de salud:
1_sistemas_informacao_saude
/
2_cobertura_universal
Asunto principal:
Ensayos Clínicos como Asunto
/
Telemedicina
/
Tecnología Biomédica
/
Medición de Resultados Informados por el Paciente
/
Capacitación en Servicio
Tipo de estudio:
Guideline
Aspecto:
Patient_preference
Límite:
Humans
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2019
Tipo del documento:
Article
País de afiliación:
Estados Unidos