Table 2 Data forms
Form # | Form title | Description | Completed by |
|---|---|---|---|
FA00 | Sampling and Initial Recruitment Log Form | Documents the outcomes of searching the clinical records for potentially eligible subjects and of initial contacts with potentially eligible subjects including their interest in participation in the study. | Clinical Coordinator |
FA01 | Contact Form | Documents contact information for each potentially eligible subject and updated contact information for participating subjects. | Information extracted initially from clinical records and reviewed/updated with potentially eligible subjects and participating subjects by the Clinical Coordinator. |
FA02 | Screening Form | Documents eligibility for participation for each study subject selected. | Clinical Coordinator |
FA03 | Enrollment Form | Documents marital status, information about children, and smoking, alcohol use, menstruation, contraception and gynecological care of the study subject. | Clinical Coordinator |
FA04 | Enrollment Confirmation Form | Records blood test results, and study medication delivery to the subject, and plans for follow-up visit. This form may not need to be completed with the subject at some sites as all the information will be available to the Clinical Coordinator. | Clinical Coordinator. |
FA05 | Follow-up Form | Confirms address information, documents menstruation, administration of study medication, and plans for next follow-up visit. | Clinical Coordinator |
FA06 | Initial Prenatal Contact Form (With Study Subject) | Documents date of last menstruation, date of pregnancy confirmation, and information about the study subject’s doctor and source of prenatal care. | Clinical Coordinator |
FA07 | Prenatal Form (With Doctor) | Documents via periodic contacts with the subject prenatal care provider, or via abstraction from prenatal care records, information about the study subject’s pregnancy, prenatal vitamins, illness, ultrasound results, etc. | Co-Principal Investigator (initial contact),Clinical Coordinator |
FA08 | Study Continuation Post Miscarriage/Stillbirth Form (With Study Subject) | Collects data from the subject about her readiness to resume participation in the study after a miscarriage/stillbirth occurrence and arrange for the date and time of the next visit if she is willing to continue in the study. | Clinical Coordinator |
FA09&10 | Miscarriage/Stillbirth Form (With Doctor) | Documents the miscarriage or stillbirth date and age, as well assessment of miscarriage/still birth product if available including the presence or absence of clefting and other malformations, etc. | Co-Principal Investigator, Clinical Coordinator |
FA11 | Delivery Form (With Subject) | Documents date of delivery, birth weight and sex of the infant, mother’s smoking and drinking habits while pregnant, and any complications and malformations associated with the baby. | Clinical Coordinator |
FA12 | Delivery Form (With Doctor) | Documents any malformations that may be associated with the baby including craniofacial malformations and abnormal delivery events. Filled with the subject’s doctor (if possible) or abstraction from the medical records of the subject. | Clinical Coordinator |
FA13 | Phone Call Form | Documents telephone calls made to the study office by the study subjects, the reason for each call, and the action taken. | (Clinical Coordinator, Co-Principal Investigator) |
FA14 | Study Termination Form | Documents withdrawal from the study by a study subject, the reason(s) for termination and approval (or not) for a two-month post termination follow-up. | Clinical Coordinator |
FA15 | Post Termination Follow-up Form | Confirms address information, documents menstruation and whether or not the former study subject has gotten pregnant. | Clinical Coordinator |
FA16 | Laboratory Form | Documents the date of blood collection, date of analysis, and results of the blood testing. | Clinical Coordinator |
FA17 | Adverse Events Form | Documents all information related to any adverse event encountered during the course of the study. | Clinical Coordinator/Co-Principal Investigator |
FA18 | Protocol Violations Form | Documents all information related to any protocol violation encountered during the course of the study. | Clinical Coordinator/Co-Principal Investigator |
FA19 | Pregnancy Confirmation Form | Documents the results of a performed pregnancy test after randomization and related schedule of study folic acid supplementation | Clinical Coordinator |
FA20 | Prenatal Form (With Subject) | Documents via periodic contacts with the subject, information about pregnancy progress, prenatal vitamins, illness, ultrasound results, smoking/alcohol etc. | Clinical Coordinator |
FA21 and FA21 Suppl-ement | Delivery Form (In-Person Evaluation of Live Birth | Documents the presence or absence of malformations and/or complications with birth upon in-person evaluation of the live born by the Clinical Coordinator. | Clinical Coordinator or Co-Principal Investigator and clinical geneticist (or pediatrician) |
FA22 (Outreach-model only) | Pre-Contact Form | Documents the outcome of each attempt to contact subject by the study staff or voluntary professionals assisting on the study. | A study team member, Social worker, Parent Coordinator |