Task | Timing | Procedure | Forms |
---|---|---|---|
Abstraction from clinical record | Sampling phase | Search clinical records to identify potentially eligible subjects | FA00 |
Introduction to study | First contact with subject (in person or by phone) | -Verify potential eligibility | FA00 |
-Verify subject address and contact information | FA01 | ||
-Introduce potential subject to the study | Â | ||
-Explain study purpose and subject responsibilities | Â | ||
-Answer any questions that potential subject may have | Â | ||
-Check willingness of potential subject to participate | Â | ||
Screening | Directly or within a week period after introduction into study | Screen subject for eligibility | FA02 |
Enrollment | Directly or within a week period after screening | -Obtain informed consent | FA03 |
-Obtain blood sample from subject | |||
-Inform subject of process of study drug dispensing and next follow-up | |||
Verification of B12 and pregnancy test results, randomization, dispensing study pills, and baseline contact | Within 1–2 weeks days after enrollment | -Verify blood test results (mainly B12 levels) | FA04 |
Randomize subjects who have no B12 deficiency and are not pregnant and dispense folic acid pills | Â | ||
Refer subjects who have B12 deficiency to hematology service | |||
Follow-up onward | Every 2 months (about 8 weeks) | -Dispense and confirm receiving folic acid pills | FA05 |
-Complete follow-up visit form | Â | ||
Follow-up when blood sampling is due | (Once every 12 months after enrollment. | -Schedule an in person follow-up for blood sampling | FA05 |
-Dispense folic acid pills | FA16 | ||
-Complete follow-up visit form |