APPENDIX A: SCHEDULE OF EVENTS {Create a detailed schematic describing all visits and assessments, consistent with those listed in Sections 7 and 8.} {Begin sample text} –Y) 1 2 4 3 Y) Y) Y) Y) Y) to ± ± ± ± ± Visit Visit Visit X X X X X –X 0) Completion Visit Procedures Discontinuation Screening Baseline Study Study Study Premature (Day (Day (Day (Day (Day (Day (Day Signed Consent Form X X Assessment of Eligibility Criteria X X Review of Medical/Dental History X X Review of Concomitant X X X X X X X X Medications Intervention X X X X X Complete X X X Symptom-Directed X (X) (X) (X) (X) Vital Signs (X) (X) (X) (X) (X) Physical Examination Behavioral Assessment X X X Assessment of Adverse Events (X) (X) (X) (X) X X Pregnancy test X X Chemistry X X (X) (X) (X) (X) X X Hematology X X (X) (X) (X) (X) X X Laboratory Urinalysis X X (X) (X) (X) (X) X X Clinical Immunology __mL whole X (X) (X) X X blood Biomarkers X X Laboratory __mL saliva Sample for X X Genetic Analysis Research Periodontal X X Measurements Pain Assessment (X) (X) (X) (X) (X) Procedures
APPENDIX A: SCHEDULE OF EVENTS {Create a detailed schematic describing all visits and assessments, consistent with those listed in Sections 7 and 8.} {Begin sample text} Procedures Screening (Day –X to –Y) Baseline (Day 0) Study Visit 1 (Day X ± Y) Study Visit 2 (Day X ± Y) Visit 3 (Day X ± Y) Study Visit 4 (Day X ± Y) Completion (Day X ± Y) Premature Discontinuation Signed Consent Form X X Assessment of Eligibility Criteria X X Review of Medical/Dental History X X Review of Concomitant Medications X X X X X X X X Intervention X X X X X Physical Examination Complete X X X Symptom-Directed X (X) (X) (X) (X) Vital Signs (X) (X) (X) (X) (X) Behavioral Assessment X X X Assessment of Adverse Events (X) (X) (X) (X) X X Clinical Laboratory Pregnancy test X X Chemistry X X (X) (X) (X) (X) X X Hematology X X (X) (X) (X) (X) X X Urinalysis X X (X) (X) (X) (X) X X Research Laboratory Immunology __mL whole blood X (X) (X) X X Biomarkers __mL saliva X X Sample for Genetic Analysis X X Procedures Periodontal Measurements X X Pain Assessment (X) (X) (X) (X) (X)
clinical-trial-interventional-protocol-template.docx