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. 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 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. 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. In this double-blind 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., active study drug vs. placebo). An IWRS system will manage treatment assignments. The only people with direct access to treatment assignments will be those individuals who develop and maintain the randomization code, the DSMB and the statistical group reporting to the DSMB.
Blinding. This clinical trial is being conducted as a double-blind study; neither the investigator, supporting staff, nor the participant will be aware of the treatment the participant is receiving.
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. Describe whether the investigators were blinded to group allocation during data collection and/or analysis. Note: all studies involving animals and/or human research participants must disclose whether blinding and randomization were used.
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. 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. July 27, 2005 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 ·
