Ceballos, Mauricio http://orcid.org/0000-0001-6181-7370
Salazar-Ospina, Andrea
Sabater-Hernández, Daniel
Amariles, Pedro
Funding for this research was provided by:
Laboratorios Laproff
Article History
Received: 20 January 2020
Accepted: 6 June 2020
First Online: 19 June 2020
Ethics approval and consent to participate
: The trial will be carried out in compliance with the protocol and the Declaration of Helsinki, following the International Conference on Harmonization. The Ethics Committee approved this study of the National School of Public Health at the University of Antioquia Colombia at the 123rd session on July 8, 2015. The researchers involved in this study would be the only ones with access to the information. The data collected will remain anonymous. Each pharmacy staff, as well as patients/caregivers, and simulated patient will receive verbal and written information about the study (purpose, procedures, potential risks, benefits, and confidentiality of the information) and a copy of the informed consent form, which explains the study in detail. Once patients resolve any questions about the study, those who agree to participate will sign the consent form.The researcher will keep the original form and deliver a copy to the pharmacy staff, as well as the patients and caregivers if they request it. The personal information of the pharmacy staff, as well as the patients and caregivers, will never be disclosed at any stage of the clinical trial (results, publications, or project presentations). The authors will guarantee the publication of the results of the trial, and the results will be shared among the participants. One of the researchers in the study will continuously and consistently review the process.There will be no biological specimens collected. There are no anticipated damages and compensation for participating in the trial. After completing the study, the pharmacy staff of the control group will receive free access to the virtual course that is part of the intervention of the continuing education program. Additionally, all the community pharmacy staff of the trial will continue to have free and open access to the social network-type web platform. They will have access to the health information that is published for the sponsor and to new virtual continuing education courses that will continue to be offered.Any changes to the protocol will be notified to the sponsor and funder first, then different involvement groups will notify the centers, and a copy of the revised protocol will be sent to the different involvement groups to add to the investigator site archive. The study will be registered in the Integrated University Information System (IUIS) of the University of Antioquia. The preliminary results of the trial will be presented at national and international conferences and published in journals and through the sponsor’s Facebook, Instagram, and Twitter social networking. Any deviation from the protocol will be fully documented in a breach report non-compliance form that will be submitted to the involvement groups. If any changes to the protocol are necessary, the protocol will be updated in the clinical trial registry.
: Authors declared they do not have any potential conflicts of interest concerning the authorship or publication of this article. MC, ASO, DSH, and PA contribute significantly to the design of the methodological approach. Data will be collected by MC and will be interpreted by MC, ASO, DSH, and PA. MC, ASO, SD, and PA will write the paper.