Trail Designing

Trail Design

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.

1
Introduction For Trail Design
10 minutes

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

Part IV: Trail design Dataset Creation on Astma project

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

Part V: Trail design Dataset Creation on Oncology project

1
3) Oncology: A Live designing.
Yes, we provide a live project based on real-time protocol document and SDTM mapping to create the trial design datasets.
No announcements at this moment.

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Enrolled: 43 students
Duration: 13 hours
Lectures: 26
Level: Advanced

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