| Paper forms | Direct data entry using personal digital assistants |
---|---|---|
Training | Training on error correction, what type of pen to use, etc. according to GCP (takes approx. 1 day with frequent retraining). | Training on use of software and hardware (takes approx. 2 days; no retraining needed). |
User friendliness/acceptability and ease of implementation | A known method for most staff, and therefore, high acceptability and easy implementation. | Unknown method for staff; high acceptability after training and initial usage; initial implementation requires supervision. |
(Remaining) Data entry time (paper-> database)* | Double data entry (14 pages): 10 minutes per patient | Double data entry (7 pages): 5 minutes per patient |
Data turnaround time | 5-7 days | Less than 24 hours** |
Data omissions | Dependent on degree of education and training; high omission (6%) seen in staff not experienced with research. | None since data can't be saved if not all of the questions are answered.** |
Data accuracy | Dependent on degree of education and training; low accuracy seen in staff not experienced with research (7% non accurate data). | High accuracy due to real-time error and consistency checks (1% non accurate data).** |
Costs | a) personnel: 2 data entry staff (19 months): USD 5,700 b) hardware: 2 computers (5,000 USD), 1 printer (1,000 USD), filing cabinets (10 × 350 USD), additional space (500 USD): USD 10,000 c) Paper forms: printing CRFs (14 pages × 2,500): USD 2,800 d) IT: database development: USD 5,000 TOTAL: USD 23,500 | a) personnel: 1 data entry staff (19 months): USD 2,800 b) hardware: 9 PDAs (each 340 USD), 1 central computer (2,500 USD), 1 printer (1,000 USD), filing cabinets for the remaining paper forms (5 × 350): USD 1,750: USD 8,310 c) Remaining Paper forms: printing lab forms (7pages × 2,500) and outcome forms(1 page × 2,500): USD 1,600 d) IT: database development USD 5,000: TOTAL: USD 17,710 |
Transferability to next project | Knowledge can be transferred to the next project. Hardware can be recycled for the next study. | Knowledge can be transferred to the next project. PDAs and other hardware can be recycled for the next study. |