programming (if applicable); duration of implant or exposure (if applicable); frequency of exposure (if applicable); if a device has not been approved or cleared for the indications the protocol is designed to investigate, then a summary/report of test validation studies should accompany this protocol. Additional notes Detail mechanisms (if any) for masking (i.e. blinding) trial interventions. For example, if a placebo is being used, note whether it has similar colour, taste, etc., to the active drug. Summarise the label copy which should include the following, as appropriate: Randomisation number, Week number, Batch number, Expiry date and the statements clinical trial use only” “For and out of reach of children” along with any local or national requirements “Keep Repeat for each trial product (investigational product, comparator, placebo). Complete relevant for medicine or device as applicable to the trial. Complete below if trial intervention is an investigational medicinal product. Active substance <List main active ingredients, quantity and unit> <Insert Trade Name> or <Insert Generic Name followed by Trade or Generic name the word GENERIC> <Insert dosage form> Dosage form e.g. tablet, capsule, injection, IV infusion <Insert route of administration> Route of administration e.g. oral, inhaled, intravenous, subcutaneous, administered Complete below if trial intervention is an investigational medical device. Product name <Insert Product Name> <Insert Device Type> Device Type e.g. single device, system, procedure pack, software. For each trial product, specify: The dose, or mg/kg, and strength of the dose unit. Consider dosage for all subjects throughout the trial period, taking into account the likely growth of babies and children The dosing regimen including Dosing intervals (single-dosing, multiple-dosing, dosing, weekly dosing)
programming (if applicable); duration of implant or exposure (if applicable); frequency of exposure (if applicable); if a device has not been approved or cleared for the indications the protocol is designed to investigate, then a summary/report of test validation studies should accompany this protocol. Additional notes Detail mechanisms (if any) for masking (i.e. blinding) trial interventions. For example, if a placebo is being used, note whether it has similar colour, taste, etc., to the active drug. Summarise the label copy which should include the following, as appropriate: Randomisation number, Week number, Batch number, Expiry date and the statements “For clinical trial use only” and “Keep out of reach of children” along with any local or national requirements Repeat for each trial product (investigational product, comparator, placebo). Complete relevant for medicine or device as applicable to the trial. Complete below if trial intervention is an investigational medicinal product. Active substance <List main active ingredients, quantity and unit> Trade or Generic name <Insert Trade Name> or <Insert Generic Name followed by the word GENERIC> Dosage form <Insert dosage form> e.g. tablet, capsule, injection, IV infusion Route of administration <Insert route of administration> e.g. oral, inhaled, intravenous, subcutaneous, Complete below if trial intervention is an investigational medical device. Product name <Insert Product Name> Device Type <Insert Device Type> e.g. single device, system, procedure pack, software. For each trial product, specify: The dose, or mg/kg, and strength of the dose unit. Consider dosage for all subjects throughout the trial period, taking into account the likely growth of babies and children The dosing regimen including Dosing intervals (single-dosing, multiple-dosing, dosing, weekly dosing) administered
2018_05_16_clin_trial_imp_annotated_prot_template_final_0.docx