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) | Â | 10 events | Data centre approach that collated, entered and managed all inputs from six study sites at centralised location |
Enrolment (29) | Enrolment (Ă—1) | ||
Clinical information (243) | Clinical information (Ă—2) | ||
Additional Assessments (74) | Additional assessments (Ă—3) | ||
Serious Adverse Events (31) | Serious Adverse Events (Ă—1) | ||
Follow up (34) | Follow up (Ă—3) | ||
CTX (12) | Â | 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 (Ă—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) | Â | 26 events | Field based laptop server with two data entry clients |
Screening (119) | Screening | ||
Pre-vaccinations check (80) | Pre-vaccinations (Ă—2) | ||
Vaccines administration (20) | Vaccine administration (Ă—2) | ||
Systemic Adverse Event (126) | Systemic Adverse Event (Ă—2) | ||
Follow ups (180) | Follow ups (Ă—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 |