Maziworld
Clinical Research
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Course sections

Section 1
Introduction to Clinical
1
Adverse event
2
SAE
3
ARM
4
Baseline
5
Randomization
6
Parallel
7
Crossover
8
DMC [Data Monitoring Committee ]
9
Eligible Criteria
10
Inclusion/Exclusion Criteria
11
Inform consent
12
Masking
13
Study Design
14
Study Documents
15
Study Start date
16
Study Type
17
Title
18
Blinded Trails
Section 2
INDA
Section 3
NDA
Section 4
ANDA applications
Section 5
Types
Section 6
Designs
Section 7
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
Section 8
Alternative Trial Designs
1
Crossover Trials
2
Factorial Design
3
Equivalence Trials
4
Bioequivalence Trials
5
Noninferiority Trials
6
Cluster Randomized Trials
7
Multicenter Trials
Section 9
Clinical Research Methodology
1
Phase 1
2
Phase 2
3
Phase 3
4
Phase 4
Section 10
ICH GCP guidelines (ICH E6)
Section 11
Roles and Responsibilities of Investigator and CRA
Section 12
Roles and Responsibilities of Sponsor and CRC
Section 13
Contract Research Organizations-CRO
Section 14
Case Report Form and its Contents with live example
Section 15
Contents of protocol
Section 16
Explanation of Research protocol with live example
Section 17
Informed Consent Form
Section 18
Institutional Review boards(IRB)/IEC
Section 19
Participant safety and Adverse events reporting
Section 20
Participant safety and Adverse events reporting
Section 21
Monitoring of Study at participating sites
Section 22
Source Data Verification
Section 23
Investigator's Brochure (IB)
Section 24
XIX. Standard operating procedures
Section 25
Essential documents
Section 26
Data Coding using MedDRA and WHODD
Section 27
CRF Design Guidelines
Section 28
SAE/AE Reconciliation

Clinical Research Methodology

Phase 3

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Clinical Research Methodology Phase 2
Completed
Clinical Research Methodology Phase 4