A Complete Clinical Overview Concept


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

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Clinical-Overview-concepts

In this section, you will learn the basic knowledge of the clinical trial overview. Before you understand the clinical trial overview its very difficult to understand the concepts of SAS clinical.

In this training, you will be learning the end-end basic concepts and able to understand the data and project documents and understanding the spec and able to interact with the stakeholders.

our main intention is used to knowing from basic they get a better experience on upcoming topics.

1. Introduction to Clinical

a. Adverse event
b. SAE
c. ARM
d. Baseline
e. Randomization
f. Parallel
g. Crossover
h. DMC [Data Monitoring Committee ]
i. Eligible Criteria
j. Inclusion/Exclusion Criteria
k. Inform consent
l. Masking
m. Study Design
n. Study Documents
o. Study Start date
p. Study Type
q. Title
r. Blinded Trails and more…

2. ICH/GCP Guidelines

3. 21 CRF Part 11

4. Clinical Research Methodology

a. Phase 1
b. Phase 2
c. Phase 3
d. Phase 4

5. Who Drug vs MEDDRA

6. Medical Dictionary

7. CDM Process to SAS

8. IRB/IEC

9. Clinical Real-time Documents

a. Protocol
b. Blank CRF
c. SAP
d. Control Terminology
e. Codelist
f. QC Checklist
g. Transition table sheet
h. SOP’S
i. SDTM and ADaM Spec
j. SDTM and ADaM Implementation Guide
k. Reviewers Guide
l. Annotated CRF’s
m. Annotated Mockup’s
o. Project Delivery Plan
p. Root Cause Docs and more…

11. Clinical Center Flow

10. SAS Flow from rawdata

ADaM Conversions and Extra Variables and Business Logics

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