Remote monitoring: real life experiences
Webinar – 24 September 2021 – 9:00 – 11:30 am
Remote monitoring is a very topical subject and the experience of the recent pandemic has accelerated its development and highlighted its potential.
AICRO will share experiences, critical issues and solutions through the testimonies of its members, who are daily engaged in the field.
The workshop is a valuable opportunity to share experiences in terms of remote monitoring in the field and in different settings: from the organisation of visits, to the focus by topic (e.g. drug management), from oversight or “site management”, to follow-up and planning of activities.
The aim is to verify the limits and potential in each context, to exchange opinions on the most appropriate methods of organisation, to evaluate the most useful, usable and desirable technological means in the future. We will also tell each other about our experiences in terms of reactions at the experimental centres and real possibilities.
The comparison may be functional to identify feasible hypotheses for Remote Source Data Verification, which is a topic still very much constrained by regulatory uncertainties.
TARGET
The workshop is addressed to CRAs, CRA leads, PLs and all “clinical operations” figures in profit and non-profit research.
PROGRAM
9:00 – 9:20
Technology and digitalisation in clinical trials – Introduction and references to monitoring principles (E. Ottavianelli/M. Carcaiso)
9:20 – 9:50
Remote monitoring: regulatory aspects (A. Canazzo/V. Montinaro)
9:50 – 10:20
Some critical focuses in remote monitoring: IP accountability (F. Papadopulos)
10:20 – 10:40
Some critical focuses in a remote visit: organization of a SIV (L. Lerusce)
10:40 – 11:00
rSDV first direct experiences with DPO, comparison with foreign countries (S. Zorzan)
11:00 – 11:20
Direct experiences of remote monitoring with or without SDV on Interventional Studies (M. Cordisco/S. Guernelli)
11:20 – 11:30
Conclusions (All)
CHAIRMAN
Elena Ottavianelli
AICRO Scientific Director, Business Development Manager – Fullcro
SPEAKERS
Andrea Letizia Canazzo
Site Start-Up Associate II – Premier Research
Marta Carcaiso
Senior Clinical Research Associate – Premier Research
Moira Cordisco
Project Manager & Start-up Specialist – Fullcro
Susanna Guernelli
Clinical Research Associate – Fullcro
Libera Lerusce
Senior Clinical Research Associate – Premier Research
Valentina Montinaro
Senior Site Start Up Associate – Premier Research
Francesca Papadopulos
Clinical Research Associate II – Premier Research
Silvia Zorzan
Senior Clinical Research Associate – IQVIA
PARTICIPATION FEE
For participants belonging to the associations AICRO, ASSOMONITOR, EUCROF, FADOI, SIMEF, and to employees of public and non-profit structures:
60,00€ – The receipt, without application of stamp duty and VAT, will be issued by AICRO – Piazza Meda 3 – 20121 Milan
For external participants
80,00€ + 22% VAT – The invoice will be issued by AICRO Piazza Meda 3 – 20121 Milano – P.IVA 05913730965
For all:
Nr. 1 free of charge every 2 (two) paying participants
The fee includes: teaching, use of the platform, teaching documentation and certificate of attendance at the end of the seminar.
