
Clinical Data Management Training
1) Importance of the course
2) Job Roles in Clinical Research
3) Pathways to Launching a Career in Clinical Research
4) How to Land a Job in Clinical Research
5) Executing Your Plan
6) History of Clinical Research
7) Good Clinical Practice
8) Safety and Patient Protection
9) Subject Recruitment
10) The Clinical Research Site
11) Therapeutic Areas
12) Monitoring of Clinical Trials
13) Organizing Your Work Clinical Monitor
14) Staff Training and Qualifications
15) Clinical Team Structure and Communication
16) Pre-Clinical Studies
17) Preclinical drug development
18) Types of Clinical Studies
19) Types of Study Designs
20) Blinding vs Randomization Process
21) Types of Clinical Data
22)Drug Regulatory Bodies in Different Countries
23) IRB and its Role
24) Drug Development Process
25) Drug Development Process all images
26) Protocol
27) Study protocol_examples_completed
28) Medical History , Adverse Events, Concomitant Medications
29) Protocol Deviations
30) Case Report Forms
31) Case Report Forms (Design of CRF)
32) Case Report Form (CRF) Design
33) Case Report Forms -(How To Review a CRF Statistical)
34) EDC SYSTEMS
35) Electronic Data Capture_Medidata Rave
36) CDM Documents
37) Data Management Plan
38) Source Data Verification
39) Discrepancy Management
40) Cleaning Data – Query Writing and Resolving Queries
41) Data issues log for cross functional teams
42) Study Startup
43) Study Conduct and Close Out and Submission
44) Data Reconcillation
45) Adverse Events vs Adverse Drug Reactions_completed
46) Serious Adverse Event Reconciliation
47) Coding Dictionaries
48) Laboratory Data Management
49) Local-Lab-vs-Central-Lab
50) Study Close Out and Submission
51) How to Create Edit Checks
52) Edit Checks
53) User Acceptance Testing (UAT)