Blinding Sample Clauses

Blinding. This is an open-label study.

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. 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. 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). The central pharmacy, designated TDNCC personnel responsible for creating drug assignment lists, and those involved in DMC report generation in accordance with the DMC Charter will be unblinded. The following study procedures will be in place to ensure double-blind administration of 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 personnel who are involved in the generation of the interim report for the Data Safety Monitoring Board (DSMB) ▪ GSH and control treatments will be identical in appearance and taste masked with syrup prior to dosing. ▪ All dispensed GSH and control treatment bottle packaging and labeling will be identical. During the study, the blind may be broken for individual subjects in emergencies when knowledge of the subject’s treatment group is necessary for further patient management or when the event meets the Food and Drug Administration (FDA) expedited reporting requirements as a suspected adverse reaction that is serious and unexpected (US Code of Federal Regulations (CFR) 21 CFR 312.32(c)(1)(i)). In those cases, knowledge of the treatment received is necessary for interpreting the event. If the blind is broken and the subject was receiving placebo, an IND Safety Report would not be submitted. However, if the blind is broken and the subject is on study drug, an IND Safety Report is submitted to the FDA and all participating investigators would be notified. Emergency un-blinding procedures are provided in the Study Manual (refer to the section on Serious Adverse Experience reporting). 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 the statistical report and dissemination of top line results to Sponsor-Investigators.

Blinding. This is a randomized, active-controlled, multi-center study. All patients will receive peginterferon alfa-2b. There is currently no ribavirin placebo available for use in this study. Therefore, Investigators, study staff and patients will be blinded to the identity of their celgosivir treatment in 2 of the 3 study groups (control and 3-way combination), while the 2-way combination will be open-label. Randomization envelopes identified by patient number will be available at each site for emergency unblinding purposes only. Packaging [****], the study drug manufacturer, will package the celgosivir capsules into high-density polyethylene bottles for dispensing to patients at study visits. Each bottle will contain a 7-day supply of capsules. Patients will receive enough celgosivir capsules to last until the Week 4 visit. At study Baseline, Week 4, and Week 8 visits, the patient will be dispensed a one (1) month supply of celgosivir, peginterferon alfa-2b, and ribavirin, as appropriate, at the assigned dose level. Peginterferon alfa-2b and ribavirin will be available in a commercially packaged format, and the appropriate dosage will be assigned to the patient based on body weight at Screening. MIGENIX Inc. 49 OF 165 CLINICAL STUDY PROTOCOL #HCV-05-002 VERSION 3 CONFIDENTIAL Labelling Each shipping carton containing bottles of celgosivir capsules will be labelled with the following information: · Sponsor identification · Protocol number · Other instructions: Keep out of reach of children, do not store in direct sunlight, and keep away from open flame. · Storage instructions: Store at room temperature ·

Blinding. Figure 5. Staged implementation scheme for the 80 participating practices.

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.

Blinding. Randomization to either Investigational or control device will only occur at the surgery visit (Visit 2) and therefore the subjects will be blinded to their randomly assigned treatment device prior to surgery and during the follow up period following surgery. While it is not possible to blind investigators and staff members to the treatment device used, Investigators and staff members will not learn of randomized device until immediately prior to use of device, so as to maintain subject blinding prior to the hernia repair. Investigators and staff members will be asked to maintain subject blinding through the course of the follow up visits so as to not bias subject feedback on applicable study assessments. No device assignment information will be included on the source documentation to be completed by the study subjects (e.g. pain and quality of life assessments) and staff members, including the Investigator(s), will be instructed to not disclose this information during each study visit. Subjects will receive the same standard of care prior to, during and following surgery regardless of randomized device assignment, and therefore will not be able to individually determine what device they have been randomized to. Randomization assignment will be revealed to subjects at conclusion of the study after all assessments and study visits are completed. A subject will be informed of their randomization assignment in the event they withdraw consent or are withdrawn from the study for any other reason.