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J Am Med Inform Assoc 16:404-408 doi:10.1197/jamia.M2787
  • Original Investigation

Developing Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with The Demand Trial

Table 2

Status of the DEMAND Trial Database

Number of patients in database 909
Number of patients enrolled 492
Number of visits 6,745
Mean visits per patient 14
Number of patients randomized 380
Number of tables—clinical data 28
Mean number of fields per table—clinical data 21
Number of clinical data records 53,378
Number of tables—other data 2
Total records—other data 157,028
Total size of the database* 550 Mbytes
  • * For 8 MaxDB instances, one for each participating center.

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