PROSLE In-Clinic and Check-in Form For Trial Coordinators "*" indicates required fields Trial Coordinator Initials* Participant ID*Participant ID is participant initials, followed by the day and month of their DOB birth. For example GA0210 Timepoint* Screening PK1 PK2 Exit interview Screening Number?*Product Number?*Has consent form been completed? Yes (at home) No (please do now in clinic) Clinic dataWas participant resting/sitting for at least 5 minutes prior to BP measurement?If no, please allow the participant to rest for 5 minutes before continuing. Yes No Blood Pressure - SystolicBlood Pressure - DiastolicPulseO2 SaturationHeight in metres?Without shoesPlease enter a number less than or equal to 3.Weight in kg?Without shoesBMI CalculationPlease check participant is within the eligibility range (18.5-29.9)Waist measurement in cmHip measurement in cmHas the sleep diary been provided? Yes Has the sleep diary been completed? Yes No (please instruct them to complete it asap) Check-In QuestionsHave you had any changes to your diet, exercise or health?*If any medication changes, please complete Con Med form Yes No Please provide details of any changes to diet or exercise?Have you missed any doses of study product? Yes No How many missed doses of study product? AEHave you experienced any issues or unwanted effects?* Yes No Is this issue or event related to a previous medical condition before you started the study?*If No, then complete an Adverse Event Form. Yes (see next question) No (requires an AE Form Is it worsening or as usual?*If Yes, then complete an Adverse Event Form. Worsening (requires an AE Form) As usual (does not require an AE Form) Have you changed or added any new medication/supplements etc?**If the medication/supplement was in relation to an unwanted effect (not already noted above), please re-check the above previous questions to check if an AE Form is also required. Yes (requires Con Med Form) No Product ADid you miss any doses of study product? (Product A)(Product A) Yes No Number of capsules remaining? (Product A)FinalDid you miss any doses of study product? (Product B)(Product B) Yes No Number of capsules remaining? (Product B)Which product did you prefer?* Product A Product B Don't know Based on your experience, would you use the product again?* Yes No Any product feedback?For example: how they found the size of the capsules, number of capsules or any other comments. Have participant's payment details been collected?*If no, please complete the relevant payment details form. Yes No Has the sleep diary been returned? Yes No (please instruct them to post or drop it in asap)
