Home / Online GXP courses / GCP : Clinical Trials / Management of Clinical Trial Protocols

Management of Clinical Trial Protocols

 5/5

49

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Clinical trials take time and consume a lot of resources, hence, they must be conducted after adequate consideration of the whole process. We must put structures in place to ensure the consistency of conditions as much as possible since this will greatly reduce errors and make the research findings reliable.

This course exposes the basics of clinical trial and data management outlining the goals, tools, and processes involved. If the data obtained from a clinical research exercise is unreliable the purpose is defeated and the resources wasted. You will also learn about the CDISC which is an organization that regulates clinical trial operations to ensure compliance with international standards.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Lesson 1: Overview of Good Clinical Practice

13 Principles of GCP

Lesson 2: What is Clinical Research and Clinical Trial?

Lesson 3: Types and Phases of Clinical Trials

Lesson 4: Clinical Trial Data Management and Professionals

What is Clinical Trial Management?
What is a Clinical Trial Management System (CTMS)?
How to Compare Clinical Data Management Systems

Lesson 5: What is Clinical Data Management?

Model for Data Management in Clinical Trials
Clinical Research Data Areas of Responsibility

Lesson 6: The Roles and Responsibilities in Clinical Data Management

What is Clinical Trial Data Management (CDM)?
Clinical Data Management Plans

Lesson 7: Clinical Trial Data Validation Plan

Data Management Workflow
Clinical Trial Data Audits

Lesson 8: Quality Management in Clinical Trials

Regulations, Guidelines, and Standards in Clinical Data Management
Case Report Forms in Data Management
Introduction to Electronic Clinical Trial Management Systems
The Business Need for CTMSs
Basic Structure, Contents, and Functioning of CTMS
Electronic System Requirements
Outputs

Glossary

Quiz

Author:

Ellena J. Jefferson

Ellena is a CAPA Manager. She serves as a Training and Quality Advisor with ICONIC plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Ellena is a fixer who continuously strives for excellence as a way of life; not just as a job.

Reviews:

 5/5

49

Data is a major driving force for research. The team has been introduced to data management and data interpretation. Thanks to Dokeos, we can now communicate in terms of reliable data.

$60

Participant(s):

Buy now

Large group ? Request a quote !

This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.