Clinical Trial Operations
The role involves overseeing and managing all aspects of clinical trials, ensuring strict compliance with regulatory guidelines and Good Clinical Practice (GCP). It includes planning, initiating, executing, and closing clinical studies efficiently, while adhering to timelines and budgets. A strong focus is placed on ensuring participant safety, maintaining ethical conduct, and ensuring accurate data collection throughout all clinical research activities.
FREE
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Course Overview
Schedule of Classes
Course Curriculum
1 Subject
Clinical Operations
57 Learning Materials
Induction and Workflow PPT
Clinical Operations Workflow
PPT
Standard Operating Procedures
SOP_CLR_CLO_001_Training of Clinical project team members
PDF
SOP_CLR_CLO_002_Transition of key Project Members
PDF
SOP_CLR_CLO_003_Non Disclosure Agreement
PDF
SOP_CLR_CLO_004_Study Feasibility Assessment with prospective PI Public sites
PDF
SOP_CLR_CLO_005_Clinical Research Document Translation and Back Translations
PDF
SOP_CLR_CLO_006_Vendor Selection and Audit for Clinical Research
PDF
SOP_CLR_CLO_007_Site Selection Visit
PDF
SOP_CLR_CLO_008_Clinical Trial Agreement with Investigator
PDF
SOP_CLR_CLO_009_Clinical Trial Supplies Management in Clinical Research Department
PDF
SOP_CLR_CLO_010_Investigators Meeting by Clinical Research Department
PDF
SOP_CLR_CLO_011_Site initiation Visit
PDF
SOP_CLR_CLO_012_Management of Essential Study Documents
PDF
SOP_CLR_CLO_013_Monitoring Visit
PDF
SOP_CLR_CLO_014_Handling protocol Deviations Public Violations in Clinical Research
PDF
SOP_CLR_CLO_015_Site Close Out Visit
PDF
SOP_CLR_CLO_016_Clinical Trial Project Management
PDF
SOP_CLR_CLO_017_Termination an Investigator for Non Compliance
PDF
SOP_CLR_CLO_018_Clinical Trial Registration On clinical Trial Portal
PDF
SOP_CLR_CLO_019_Destruction of Clinical Study Documentation
PDF
SOP_CLR_CLO_020_Quality Audits at Sites in Clinical Research
PDF
SOP_CLR_CLO_021_Site and Monitoring Audits for Clinical Research Department
PDF
SOP_CLR_CLO_022_AE and SAE Monitoring Management in Clinical Research Department
PDF
SOP_CLR_CLO_023_Preparation of Study Logs and Forms in Clinical Research Department
PDF
SOP_CLR_CLO_024_Clinical Research Compensation and Reimbursments for SAE
PDF
SOP_CLR_CLO_025_Archival of Clinical Trial Documents
PDF
Introductory Video
Clinical Operations_Introductory Video
Video
00:02:23
Department Wise Content
PDF
Introduction to Clinical Research
Introduction to Clinical Research
Video
00:57:14
Clinical Trial Assistant
Clinical Trial Assistant
Video
00:27:34
Clinical Research Associate
Clinical Research Associate
Video
00:22:20
Clinical Project Manager
Clinical Project Manager
Video
00:23:51
Clinical Research Coordinator
Clinical Research Coordinator (CRC)
Video
00:41:27
Principal Investigator Role in a Clinical Trial
Principal Investigator Role in a Clinical Trial
Video
00:43:26
Clinical Project Management
Clinical Project Management
Video
00:32:06
Translation Requirements in Clinical Trial
Translation Requirements in Clinical Trial
Video
00:34:46
Budget Management in Clinical Trials
Budget Management in Clinical Trials
Video
00:22:41
Outsourcing in Clinical Research
Outsourcing in Clinical Research
Video
00:18:27
Site Feasibility and Site Selection Visit
Site Feasibility and Site Selection Visit
Video
00:37:31
Essential Documents for Conduct of a Clinical Trial
Essential Documents for Conduct of a Clinical Trial
Video
00:41:48
Ethics Committee
Ethics Committee-IRB
Video
01:00:46
Screening Committee Member
Screening Committee Member
Video
00:19:18
Clinical Event Committee
Clinical Evaluation Committee
Video
00:55:54
Data Safety Monitoring Board (DSMB)
Data Safety Monitoring Board (DSMB)
Video
00:19:47
Steering Committee
Steering Committee - Clinical Research
Video
00:17:00
Electronic Trial Master File (eTMF)
Electronic Trial Master File (eTMF)
Video
00:27:30
Clinical Trial Management System (CTMS)
Clinical Trial Management System (CTMS)
Video
00:32:14
Interactive Response Technology (IRT)
Interactive Response Technology (IRT)
Video
00:17:07
Electronic Data Capture
Electronic Data Capture
Video
00:14:40
Site Initiation Visit (SIV)
Site Initiation Visit (SIV)
Video
00:23:50
Informed Consent
Informed Consent
Video
00:28:07
eConsenting in Clinical Trials
eConsenting in Clinical Trials
Video
00:28:02
Risk Based Monitoring
Risk Based Monitoring in Clinical Trials
Video
01:05:48
Interim Monitoring Visit
Interim Monitoring Visit (IMV)
Video
00:27:18
Serious Adverse Event
Serious Adverse Event
Video
01:07:59
Decentralized Clinical Trial
Decentralized Clinical Trial (DCT)
Video
00:28:24
Site Close Out Visit
Site Close-Out Visit
Video
00:22:19
Course Instructor
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