Table 1.

Functions and features of mobile device–based electronic data capture (mEDC) and relevant requirements as per electronic data capture (EDC) guidelines.

No.	Functions and features of mEDCa,b		Requirements per EDCa,c guidelines and comments
1	Site equipment and administration
		Logistic management	Should be maintained either onsite or be remotely accessible through electronic files (IV-B: SOPd [11])
		Role allocation	Access must be limited to authorized individuals (IV-D-1: Limited access [11])
2	Patient recruitment and data collection
		Screening	These 6 parts follow “Guidance for Industry Computerized Systems Used in Clinical Investigations” [11]: each step will be used to create, modify, maintain, archive, retrieve, or transmit source data (IV-A: Study Protocol [11]), ensure the system’s date and time stamps are accurate (IV-D-3: Date/Time stamps [11]), alert the user if data are out of acceptable range, and should not automatically enter data (IV-F-1: Direct Entry Data [11])
		Data collection at baseline
		Centralized randomization
		Data collection during follow-up
		BPe measurement
		Record of adverse events
3	Patient referral and reference data
		Biological sample collection	The same as No. 2 (same as above)
		Medicine prescription
4	Remote validation of data		To assure that data are reliable, complete, and accurate (Data entry and data processing [10]); keeping track of all changes made to data in electronic records (IV-D-2: Audit trails [11]); audit trails can be particularly appropriate when users are expected to create, modify, or delete regulated records during normal operation (III-C-2: Audit trails [12])
5	Data storage and management		A copy of the data should be maintained at another location, typically at the clinical site (IV-C: Source documentation and records retention [11], data entry and data processing [10], measuring data quality [12]); should be accessible only by using their own password (IV-D-1: Limited access [11]) Procedures and controls should be put in place to prevent altering, browsing, querying, or reporting of data via external software applications (IV-E: External security safeguard [11]) Provided to FDAf and should fully describe and explain how source data were obtained and managed and how electronic records were used to capture data; have dependable system documentation (IV-F-2: Retrieving data [11]) Create and preserve electronic records, sufficient backup, and recovery procedures (IV-F-4: System controls [11])
6	Institutional Review Board operations
		Clicking a photograph of informed consent forms to ensure completion of IRBg operations	No requirements for IRB operations in the guidelines
7	Other functions and features
		Quality control for BP measurements	No requirements for quality control of BP measurements in the guidelines
		Quality control for consistence of medicine codes	Ensuring processes are defined to integrate laboratory and other non-CFRh data with the data from the eCRFi (Electronic Data Capture Principles [10])
		Project progress and status reports	Automate generation of reports on metrics and project status to facilitate project or site or patient management (Electronic Data Capture Principles [10])

^aMobile phone Redmi Note (5.5 inch, 1GB RAM, 32GB ROM, 4G Dual SIM, Android system v4.2) was used as the mobile device. Moreover, mEDC can be installed and used in mobile phones from most other brands that are based on the Android system.

^bmEDC: mobile device-based electronic data capture.

^cEDC: electronic data capture.

^dSOP: standard operating procedure.

^eBP: blood pressure.

^fFDA: Food and Drug Administration.

^gIRB: Institutional Review Board.

^hCFR: Code of Federal Regulation.

ⁱeCRF: electronic case report form.