Trail Designing

Trail Designing


Duration: 30 Days
Level: Advanced
Prerequisite: SDTM
Fast-Track: Available
Fast-Track Duration: 15 Days

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A-Professional-Trail-Designing

Trial Design Model provides a standardized way to describe those aspects of the planned conduct of a clinical trial shown in the study design diagrams of these examples. The standard Trial Design Datasets will allow reviewers to:
• clearly and quickly grasp the design of a clinical trial
• compare the designs of different trials
• search a data warehouse for clinical trials with certain features
• compare planned and actual treatments and visits for subjects in a clinical trial.

Itroduction For Trail Design

Part I: Fundamentals of Trial Design

1.Randomized Clinical Trials
2.Uncontrolled Trials
3.Protocol Development
4.Endpoints
5.Patient Selection
6.Source and Control of Bias
7.Randomization
8.Blinding
9.Sample Size and Power

Part II: Alternative Trial Designs

1.Crossover Trials
2.Factorial Design
3.Equivalence Trials
4.Bioequivalence Trials
5.Noninferiority Trials
6.Cluster Randomized Trials
7.Multi-Center Trials

Part III : SDTM Trail Design Domains

1.TA : Trail Arms
3.TI : Trail Inclusion/Exclusion
2.TV: Trail Visits
4.TE: Trail Elements
5.TS : Trail Summary
6.TD: Trail Disease Assessment

Part IV: Trail design Dataset Creation on Astma project

1) Astma : A Live Explanation
2) Trail Design dataset creation /Spec using SAS.

Part V: Trail design Dataset Creation on Oncology project

1) Oncology: A Live designing.

ADaM Conversions and Extra Variables and Business Logics

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