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Table 3 Details of exemplar case studies

From: Experience of using an open source clinical trials data management software system in Kenya

Study name & approximate database size (Mb) Description data of distinct CRF (# of data items) Number of events Method of OC deployment
FEAST (32)   10 events Data centre approach that collated, entered and managed all inputs from six study sites at centralised location
Enrolment (29) Enrolment (×1)
Clinical information (243) Clinical information (×2)
Additional Assessments (74) Additional assessments (×3)
Serious Adverse Events (31) Serious Adverse Events (×1)
Follow up (34) Follow up (×3)
CTX (12)   7 events Data entered into the centralised system directly from the four study sites
Enrolment (71) Enrolment
Discharge Information (21) Discharge
Follow ups (198) Follow ups (×9)
Study conclusion (12) Study conclusion
Adverse Events (13) Adverse Event
Serious Adverse Events (14) Serious Adverse Event
Concomitant medication (28) Concomitant medication
TRAPVAC 046 (5.5)   26 events Field based laptop server with two data entry clients
Screening (119) Screening
Pre-vaccinations check (80) Pre-vaccinations (×2)
Vaccines administration (20) Vaccine administration (×2)
Systemic Adverse Event (126) Systemic Adverse Event (×2)
Follow ups (180) Follow ups (×6)
Concomitant Medication (7) Concomitant medication
Adverse Event (15) Adverse Event
Serious Adverse Event (7) Serious Adverse Event
End of study (3) Unscheduled Visit
End of study