Operational AspectsII Study Forms Subject Enrollment Log DemographicClinical

Operational Aspects-II

Study Forms • Subject Enrollment Log • Demographic/Clinical Form • Cold-chain Maintenance Form • Result of Rapid Diagnostic Test for Influenza Form

Subject Enrollment Log Document of subject enrollment, link between subject number and identifier information, tracking number of subject enrollment. Ø Complete following information in Subject Enrollment Log after obtaining Informed Consent Form: q Subject number (Pre-printed Label) q Subject name q Hospital number / Admission number q Date of informed consent (dd/mmm/yy: 11 Jan 16) q Mark (√) if Consent form was given to subject q Staff Initials/date (dd/mmm/yy: 11 Jan 16) q Remark

Subject Enrollment Log

Subject Enrollment Log Stick Barcode Name Write HN 11/JAN/2016 AB 11 JAN 16

Demographic/Clinical Form Version 6. 0 dated 16 July 2015 Demographic/Clinical Form is used to confirm eligiblity criteria and collecting: • Subject’s demographic data (e. g. gender, occupation, date of birth) • Subject’s Clinical data (e. g. Exposure, medical history, signs/symptom, diagnosis) • Type of specimen and Rapid Diagnostic test result

Demographic Form Section 1: Eligible Criteria

* Very important information-Must be completed * wrong PS 2 NOV 12 Paracetamol wrong Amoxycillin correct

* Very important information-Must be completed * * * AB * 11/JAN/2016

Cold Chain Maintenance Table Form

Cold Chain Maintenance Table Form Bhutan Paro Hospital 1 Stick Barcode 11 JAN 16 2016

Cold Chain Maintenance Table Form Sangay 11/JAN/16

The Result of Rapid Diagnostic Test �The Result of Rapid Diagnostic Test by Using the Quick. Vue Influenza A+B Test Kit will be recorded in the Result of Rapid Diagnostic Test for Influenza Form. This form will be sent to the physician for support the diagnosis.

The Result of Rapid Diagnostic Test

Demographic form

Cold-chain Form

Patient in OPD>> Doctor fills up Demographic/ Clinical form >> Patient goes to Lab>> Lab obtains informed consent/ Assent >> Subject enrollment>> Collect specimen, perform rapid test >> Complete Demographic/ Clinical form >> Fill up cold-chain maintenance form