Course Description
Clinical Research is one of the most knowledge-intensive industries. It is complete biography of drug from its inception in the lab to its introduction to the consumer market and beyond. Any molecule is identified is subjected to pre-clinical and clinical trials before entering in to market. Though post marketing surveillance is also part of the same. Pre-clinical studies are associated with effect of drug on animals. All the toxicological studies, tests for teratogenicity, carcinogenicity are carried out. After this, the data obtained from the studies are submitted as an IND (Investigational Drug Application) to take permission for human studies. Then, it is enter in to clinical trials.
Target Customers for this course:
Pre-Requisites for this course:
- Basic Computer Knowledge
- Passion to learn
- Any Science Graduates/ postgraduates / doctors
Course Objective:
- Clinical trials are prospective biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions (novel vaccines, drugs, treatments, functional foods, dietary supplements, devices or new ways of using known interventions), generating safety and efficacy data.
- They are conducted only after satisfactory information has been gathered that satisfies health authority/ethics committee approval in the country where approval of the therapy is sought..
- Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. As positive safety and efficacy data are gathered, the number of patients typically increases. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries.
- A full series of trials may cost hundreds of millions of dollars. The burden of paying is usually borne by the sponsor, which may be a governmental organization or a pharmaceutical, biotechnology or medical device company. When the required support exceeds the sponsor’s capacity, the trial may be managed by an outsourced partner, such as a contract research organization or an academic clinical trials unit.
How to access:-
Step 1 - eduCBA sends the redemption coupon along with the registration link.
Step 2 - Student will register with his register email id and coupon
Step 3 - Student receive the course access and password on his/her email id
Step 4 - Login using your email id and password and start learning
Benefits of online course:
1. High Quality Content
2. Learn Anywhere Anytime & at Your Pace
3. 24X7 Customer Support
4. Complete Student Support Throughout The Program
5. Online Video Training Material
6 Lifetime course access
7. Course Completion Certificate
For any Query feel free to call
Mob- +918587999769/9818826705
Curriculum
Section 1: Introduction to New Drug Discovery
1 New Drug Discovery
2 Clinical Trial Therapy
3 Food, Drug & Cosmetic Act
4 Thalidomide tragedy
5 Approaches to Drug Discovery
6 Drug Development Stages
Section 2: International conference harmonization
7 Intro ICF
8 His of ICF part 1
9 His of ICF part 2
10 process of icf
Section 3: Adverse Drug Reaction
11 Adverse Drug Reaction
12 Casualty Classification
13 Seriousness Classification
14 Mechanism Classification
Section 4: Project management
15 introduction to project management
16 stages in project management Part-1
17 stages in project management Part-2
18 introduction to schedule y
19 changes in schedule y
20 responsibility and appendix Part-1
21 responsibility and appendix Part-2
22 responsibility and appendix Part-3
Section 4: Clinical Research Phases
23 introduction to cro
24 Phase 1 Part-1
25 Phase 1 Part-2
26 Phase 2
27 phase3
28 introduction ICH_Part 01
29 introduction ICH_Part 02
30 ich categories
31 phase 4 intro
32 types of phase 4
33 intro ICMR
34 principal of icmr
Section 5: Regulatory Guideline in Clinical research
35 introduction to gcp
36 section of ich gcp_Part 01
37 section of ich gcp_Part 02
38 introduction to sop
39 writing sop_Part 01
40 writing sop_Part 02
41 introduction
42 what where who to report
43 medwatch
44 QOL intro
45 QOL in detail
Section 6: Pharmacovigilance
46 introduction to pharmacology
47 pharmacodynamics
48 pharmacokinetics
49 introduction to medical writing
50 characteristics
51 introduction to clinical trail design and biostats
52 clinical trail design_Part 01
53 clinical trail design_Part 02
54 selection of design
Section 7: Clinical Research Process: outsourcing
55 Outsourcing Introduction
56 Types of Contract
57 Outsourcing Process
58 Outsourcing Process Continue
Section 8: Fraud and Misconduct
59 Introduction Fraud and Misconduct
60 Prevalence of Fraud
Section 9: Special Trail: BABE
61 Introduction to Bio Equivalence Studies
62 Parameters Bio Equivalence
63 FDA Guideline
Section 10: Communication
64 Definition Communication
65 communication Skill in Clinical Research
