Blinding Sample Clauses

Blinding. Blinding shall be of the same materials as the hardcore be, crushed and graded from 4 mm upwards, free from clay, chemical or other pollution, pests, weed roots and rubbish.

Blinding. ‌ Each study in the protocol is open label; no blinding to treatment assignment for individual subjects or their care-providers will be performed. However, aggregate study results will be blinded and tightly controlled until the end of each study.

Blinding. This is an open-label study.

Blinding. Blinding of selected laboratory results is available as an optional service from QLAB. If The Sponsor determines that there is a requirement for blinding of results in this clinical trial, such requirements will be defined in the Scope of Work.

Blinding. This study is single blind. The participant will be blinded to which study vaccine (MVA-NP+M1 or placebo) they are administered. The Investigator and all study staff acting to determine or record safety, as well as all laboratory staff will also remain blinded (“observer blind”). The pharmacist and any study staff administering the study vaccine will not be blinded. The volume and site of vaccination will be the same for both Group 1 and Group 2. Identical syringes and needles will be used for preparation and administration of each study vaccine. Study vaccine will be prepared out of sight of the participant.

Blinding. Blinding of the investigational drug will be implemented by the site research pharmacies using identical containers, and instructions. The Central Research Pharmacy will maintain a master record of subject assignment. Subjects and all personnel involved in conducting the trial will remain blinded to treatment assignment and undergo a blinding questionnaire at study end.

Blinding. The Phase 2 portion of the study is open-label. For the double-blind Phase 3 portion of the study, all patients, investigators, site personnel, laboratories, and central readers with direct involvement in the conduct of the study or their designees will be blinded to treatment assignments. To prevent potential bias, appropriate measures will be taken to ensure the blind is maintained for the patients and personnel mentioned previously. To maintain the blind, investigators will distribute blinded study drug treatment kits to patients as directed by the IWRS system. Investigators and patients will not be blinded to dose level, but will be blinded to treatment assignment (i.e., bardoxolone methyl vs. placebo). An IWRS will manage treatment assignments and dose-titration. The only people with direct access to treatment assignments in the Phase 3 portion of the study will be those individuals who develop and maintain the randomization code, the Data Monitoring Committee (DMC) and the statistical group reporting to the DMC. 9.6.1. Patient Unblinding

Blinding. The formation surfaces on which concrete is to be placed shall be covered with either blinding concrete not less than 75mm thick, or waterproof, building paper, or polythene sheeting immediately after completion of the final trimming of the excavation.

Blinding. To ensure that knowledge of outcomes does not influence group creation, all persons involved in the studies will be kept blind to outcomes (death, liver transplant, hospitalization for decompensation) until after the analytic groups are created and the SMR weights are finalized. The event file will be kept separate from the primary data containing patient demographic, medical history, treatment, and laboratory data and will not be accessible to study personnel. Once the OCA-treated and non–OCA-treated datasets are created and approved by the CRC, the CRC will notify non–study-affiliated designees at each site that the event data can now be accessed in order to perform the effect size analysis and statistical testing.

Blinding. Study treatments will be administered in a double-blind fashion (i.e., subjects and site research staff will not know the treatment assigned, with the exception of the dispensing site pharmacist, central pharmacy, and designated TDNCC personnel. The following study procedures will be in place to ensure double-blind administration of test and control (IV gallium/placebo) study treatments: • Randomization assignments will be stored in a secure database and appropriately protected and backed up. • Access to the randomization code will be strictly controlled and limited to designated TDNCC study personnel. All other study personnel, investigators, and subjects will remain blinded to their study drug assignment throughout the study. • A volume and appearance-matched placebo will be utilized. • The site pharmacist will apply a blinded label to each one-liter bag of study drug. The study blind will be broken on completion of the clinical study and after the study database has been locked and study results released. The site investigators will be provided with each subject’s treatment assignment following completion of data analysis. During the study, the blind may be broken only in emergencies when knowledge of the subject’s treatment group is necessary for further patient management.