Per Protocol Population Sample Clauses

The 'Per Protocol Population' clause defines the subset of study participants who have adhered strictly to the clinical trial protocol and are therefore included in specific analyses. This group typically excludes individuals who deviated from key study procedures, missed critical visits, or failed to take the investigational product as directed. By focusing on participants who followed the protocol as intended, this clause ensures that the study's efficacy results reflect the treatment's effect under ideal conditions, thereby providing a clearer assessment of the intervention's true efficacy.
POPULAR SAMPLE Copied 2 times
Per Protocol Population. The Per Protocol Population includes all patients who meet the study entry criteria and provide complete data, are at least 90% compliant with study treatment, and have no dose adjustments.
View SourceView Similar (3)
Per Protocol Population. The Per-Protocol (PP) population includes subjects in the mITT population who complied with treatment and did not have any protocol violations. A protocol violation is defined as a deviation from basic requirements of the study protocol, including inclusion and exclusion criteria, concomitant medication restrictions, or any other protocol requirements that result in a significant added risk to the study subject or has an impact on the quality of the data collected or the outcome of the study. A protocol deviation is defined as a deviation from the protocol that does not impose added risk to the study design or the study subject. The criteria for the determination of the evaluability of subjects will be defined in the Statistical Analysis Plan.
View SourceView Similar (2)
Per Protocol Population. Subjects in the ITT population who have no protocol violations, received no bisphosphonates or inhaled chronic antibiotics from 7 days prior to Day 1 through
View Source

Related to Per Protocol Population

  • Protocol The attached Protocol shall be an integral part of this Agreement.

  • Information Technology Accessibility Standards Any information technology related products or services purchased, used or maintained through this Grant must be compatible with the principles and goals contained in the Electronic and Information Technology Accessibility Standards adopted by the Architectural and Transportation Barriers Compliance Board under Section 508 of the federal Rehabilitation Act of 1973 (29 U.S.C. §794d), as amended. The federal Electronic and Information Technology Accessibility Standards can be found at: ▇▇▇▇://▇▇▇.▇▇▇▇▇▇-▇▇▇▇▇.▇▇▇/508.htm.

  • Prescription Drug Plan Retail and mail order prescription drug copays for bargaining unit employees shall be as follows:

  • Prescription Drug Quantity Limits We limit the quantity of certain prescription drugs that you can get at one time for safety, cost-effectiveness and medical appropriateness reasons. Our clinical criteria for quantity limits are subject to our periodic review and modification. Quantity limits may restrict: • the amount of pills dispensed per thirty (30) day period; • the number of prescriptions ordered in a specified time period; or • the number of prescriptions ordered by a provider, or multiple providers. Our formulary indicates which prescription drugs have a quantity limit. Prescription drugs and diabetic equipment or supplies can be bought from the following types of pharmacies: • Retail pharmacies. These dispense prescription drugs and diabetic equipment or supplies. • Mail order pharmacies. These dispense maintenance and non-maintenance prescription drugs and diabetic equipment or supplies. • Specialty pharmacies. These dispense specialty prescription drugs, defined as such on our formulary. For information about our network retail, mail order, and specialty pharmacies, visit our website or call our Customer Service Department.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.