Clinical Research

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What Clinical Research?

Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose and treat illness. … Simply put, it involves human participants and helps translate basic research (done in labs) into new treatments and information to benefit patients.

Materials :

Books and Daily notes will be provided by us along with that recording also will be provided for reference . Step by step notes will be provided and excersises also.

Sample Videos : We request you that first don’t join the course directly as we provide the sample videos in the cirriculam first watch that try to understand. If you understand and feel comfortable with trainer explanation then gohead for classes. Join the course.

Working hours  : 9:00 am ist  to 8 pm ist .

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

Faq Content 1
Faq Content 2

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Enrolled: 77 students
Duration: 20 Days
Lectures: 38
Video: Available
Level: Advanced

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Working hours

Monday 9:00 am to 8 pm ist
Tuesday 9:00 am to 8 pm ist
Wednesday 9:00 am to 8 pm ist
Thursday 9:00 am to 8 pm ist
Friday 9:00 am to 8 pm ist
Saturday 9:00 am to 8 pm ist
Sunday Closed