Table 1 A comparison of paper case report forms with 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.