CASE OF SUCCESS
Innovación a partir de la Pandemia
Por Dra Dora Inés Molina de Salazar
First Latin American Congress of Clinical Research
I want to thank the organizing committee of the first Latin American Congress of Clinical Research and especially its president, Dr. Liliana Rodríguez.
This is my CV, I declared for this specific conference that I have no conflict of interest.
The purpose of this conference is:
Show a successful experience to the internal medicine IPS of Caldas.
Innovation from the pandemic, facing the challenges and the adaptation process that we had to generate in the confinement due to the coronavirus.
The topics I want to talk to you about are:
- Systematized clinical history
- Application of informed consent
- Home care
- Online paperwork
- Clinical laboratory
- Pharmaceutical service
- Financial management
- Electronic payroll
- Management of the Ethics Committee
About the systematized clinical history
We managed to systematize all our medical records, with a Venus software provider, adjusted to local, national and international standards, here are some screenshots of the procedure and systematization.
We did it by generating information through the plochet of each study, the benefits of this history is the access, availability and integrity of clinical information.
Legibility, traceability and auditing, security and confidentiality, legality, optimization of medical and coordination time, was extraordinary.
We also saw a huge improvement in the interaction of processes in the different areas and, of course, a decrease in paper consumption in the area of informed consent.
Application of informed consent.
Virtual and electronic consent favors the participation of research subjects in clinical studies, especially when they are isolated or hospitalized.
Strengthening the systematization processes of research centers is an innovation tool for attracting clinical studies.
Of course, it reduces paper consumption, optimizes medical and coordinator time and, according to Alcoa, improves the quality of studies, these are some screenshots that illustrate it.
The third item is home care, which generated a greater responsibility of the caregivers and the family in the research process of the subjects, improved the quality of life of the participants, provided a sense of intimacy and well-being, decreased costs in the participants and minimized the risk of contagion of infections.
Telemedicine contributes as a fourth item to improve care, avoid non-compliance in visits according to protocols, because they offer greater comfort to the participant by reducing the need to travel, improve the timeliness of care, reduce the possibility of infection or contamination crusade.
It also facilitates the continued accompaniment of the family environment and offers the participant or companion a personalized and much more humane service.
Online procedures with electronic signatures allowed the center to speed up the time used in procedures, reducing shipping costs, facilitating greater interaction between the parties and allowing an immediate response from any location.
Patients could make appointments through the website, contracts and estimates were signed through Houssay’s electronic signature.
In the clinical laboratory, a very interesting process was generated through systematization that can send prior information, taking laboratories for the specific conditions of some clinicians, but interfaces were also used that connect laboratory equipment for work in the processing of the samples and that they were much safer and more efficient through the systematized programs of Venus Enterprise and Eclipse.
The entry of laboratory tests of these studies in these systems is parameterized from the plochet of each study in the post-analytical phase, these results pass or pass directly from the equipment to the system, which allows there to be no errors in the transcription of the laboratories and with the blinding of the results, the doctor can make a timely review of them in real time.
In the post-analytical phase, there are remote sensors that alert the personnel and laboratory equipment when there is a discussion of temperatures, and this is a process that takes place 24 hours a day, seven days a week, as well as the handling of ultra-freezers. that allows the prolonged storage of the samples to avoid loss of reagents or samples that are necessary for future analysis of the studies.
The web telemetry system in the post-analytical phase in the deep freezer allows graphing and tabulation of data, visualization of variables in real time, visual alarms on the interface, email notification, text message to the person in charge, what are the advantages in a clinical laboratory of the systematization process, these are necessary tools that generate safety, quality and efficiency in all chemical laboratory processes.
The seventh item is the pharmacy issue.
The pharmacy today at IPS Médicos Intenso de Caldas has ample spaces and modules that allow the research product to be properly stored.
There is a cold chain to maintain the medicine with permanent monitoring through cell phones of the temperature excursion and that also allows us, through the software that is also the supplier is Venus, to enter the research product or dispense it. , taking into account the code assigned to each patient by the IBR of the different studies.
This is a process that is duly filed and that gives us in real time, time of delivery and dispensing of the medication.
In financial management this is an important procedure because the software is a tool to have total control over financial information of any entity in our institution, the billing process has been improved with electronic billing through the parameterization of all studies clinics with contract parameterization, manual budget, tariff, portfolio management and collection, defined procedures in terms of receipt, review and accrual of accounts payable.
This is a sample of the electronic invoice and this whole process has served for the pertinent information to the control and vigilance organisms and has allowed us to have control of the study, analysis of the real results of the species compared with objectives, plans and programs institutions, both in the short, medium and long term, also allows financial reports to be drawn up.
We have the electronic payroll that, through Antares software, has allowed us to connect with the electronic invoicing of the DIAN, this electronic payroll allows us to generate payroll documents on a monthly basis, transmit the information to the DIAN, validate the information by the DIAN, generate the graphic representation in QR, that is, it issues and notifies all this procedure in an electronic document.
Management of the Ethics Committee.
The last item is the management of the Clinical Research Ethics Committee.
The CREICEC ethics committee has been investing in systematization, betting on innovation and the search for sustainable results over time that improve the competitiveness and quality of the committee, it has a Venus platform that improves administrative and document management of the committee, through online notifications and submissions, consult information in real time, electronic signature, submission letters and notifications.
It is important to bear in mind that the committee’s responses can be downloaded from the software that it will report, situation and deviations that are submitted to the committee with their respective analysis, there are indicators in evaluation and response time and it has been reduced by 90%. the use of paper.
These are some screenshots that allow you to see how the filing, evaluation, response is done and how the minutes can also be viewed through the system.
The systematized filing has improved the time in terms of submitting the documents to be sectioned, allows cross-tracking of the documentation, improves indication, evaluation and response times.
It has allowed the Committee to have a documentation evaluation process and response times according to the filings that reach the Committee. Response times have been optimized with measurement of indicators that allow processes to be improved each time and improve the quality of care.
The Ethics Committee has a procedure called Risk Management, which is very important, because it assesses the risk in clinical research with a focus on the safety of the clinical study participant.
A methodology was designed through which the Ethics Committee has the possibility of monitoring the execution of the clinical studies of the Research Center, obtaining critical criteria in their execution for the definition of specific and objective activities and to mitigate the risks to which the participants are exposed, in this risk management there is real-time monitoring of deviations, adverse events and indicators and graphic information are handled that are sent month by month from the Ethics Committee.
Each research center can find out which studies have the most events, the characteristics of the events and how the follow-up has been.
Thank you very much for the invitation, for your attention.
As the presentation was short due to the time, we were willing from the center to present the much broader information or from the Venus provider to show how the system works, thank you very much and blessed day.
By Dr. Dora Inés Molina de Salazar.
Director of the Clinical Research Center mic.