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Table 4 Schedule A (Data collection before any detection of a menstruation delay)

From: Oral cleft prevention program (OCPP)

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  
-Explain study purpose and subject responsibilities  
-Answer any questions that potential subject may have  
-Check willingness of potential subject to participate  
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  
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  
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