1. Purpose of data collection: For research, for public health surveillance, or others
For Clinical trials, they are transitioning from traditional paper-based method to Electronic Data Capture (EDC) system to facilitate data collection across multiple sites worldwide. These sites include university hospitals and private clinics in various countries such as America, Canada, Brazil, the UK, Germany, the Netherlands, Benin, South Africa, Hong Kong, South Korea, Japan, Australia, New Zealand, and more. Currently, there are over 70 ongoing studies from well-known pharmaceutical/med tech companies that focused on vaccines, drugs, and medical devices for testing/trials in human subjects.
2. Was it primary or secondary data collection?
Primary data collection
3. Methods used for data collection
A. EDC (Electronic Data Capture) for administering questionnaires via phone.
B. ePRO (electronic Patient-Reported Outcomes) application for subjects to enter their eDiary entries after finishing medication, surgery operations, or using medical testing devices.
4. Were there any problems that occurred regarding data collection?
• Language barriers (subjects are enrolled around the world with different languages) – this case must be administered with language translator.
• Sensitive information of subjects is blinded to protect privacy and prevent bias (e.g., name, DOB, sex). Subjects may forget their study number or number card lost, this make verification difficult. Additionally, subjects may forget their password to log in to the ePRO app, and it is mandated not to ask for subject’s name or DOB – should contact site staffs in this case to verify if they are responsible for.
• Generation gap, older subjects may find it difficult to navigate technology and smartphones, especially if they are using older devices that are incompatible with the ePRO app + smartphones must have updated versions – could navigate and instruct them slowly and put extra efforts to assist.
• Different time zones can pose challenges, for example sites in Australia may face difficulties due to systems being built in North America, resulting in approximately 12-hour time differences, exacerbated by daylight saving time changes – may let site hold off and complete data on paper in the meantime and escalate to Software Engineering team for further investigation.
•Technical issues such as Wi-Fi or phone connection problems – ensure subject’s devices are connected to their home/phone wi-fi before proceed further.
• Damage to medical devices or phones – take unique device’s number or let them use other alternative devices if use own devices.
• Internet outage due to natural disasters – plan for offline works and try to keep sites informed for urgent matter via phone if possible.
• Unclear communication and the need for quiet, safe places for administering questionnaires and auditing purposes – may request subject to find quiet and safe place and keep them informed that it’s for their confidentiality.
• Awareness of data loss, If previous data entries still exist in the app, precaution is needed to avoid data loss. Follow-up may be required to synchronize data into the EDC system once the connection is stable – always follow the steps from case study and read all applicable instructions on how the system works.