Clinical Research

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
INDA
NDA
ANDA applications
Types
Designs
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
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
Clinical Research Methodology
1
Phase 1
2
Phase 2
3
Phase 3
4
Phase 4
ICH GCP guidelines (ICH E6)
Roles and Responsibilities of Investigator and CRA
Roles and Responsibilities of Sponsor and CRC
Contract Research Organizations-CRO
Case Report Form and its Contents with live example
Contents of protocol
Explanation of Research protocol with live example
Informed Consent Form
Institutional Review boards(IRB)/IEC
Participant safety and Adverse events reporting
Participant safety and Adverse events reporting
Monitoring of Study at participating sites
Source Data Verification
Investigator's Brochure (IB)
XIX. Standard operating procedures
Essential documents
Data Coding using MedDRA and WHODD
CRF Design Guidelines
SAE/AE Reconciliation
Productivity Hacks to Get More Done in 2018
— 28 February 2017
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