Good Documentation Practices (GDP) | Documentation in Clinical Trials
Category:
Clinical Research
 
Duration:
10 Days
 
CSDT BROCHURE
 
Enroll and Tuition
 

TMF and CTMS Documentation

Qtech-Sol is a Clinical Science Training Provider. The training provides in-depth knowledge about the Role of a CRA towards Source Documentation, Managing Trial Master File (TMF) and Basics of Tracking Records using Clinical Trial Management System (CTMS). An Ideal person must have bachelor’s degree in degree in life science or other health-related discipline to become a CRA or CRC. Few entry-level positions (CTA) require Associate or High school diploma. Qtech-Sol CRA Coursework is not wet lab experience, these are computer related roles performed using clinical data and tools, to support the progress of clinical trials being conducted. Person must have basic computer knowledge and works with Microsoft Word, Excel, Notepad, PowerPoint etc. The ideal person works within pharmaceutical or at hospital and research centers.

A Clinical Research Associate (CRA) manages clinical trials and studies related to pharmaceutical and biotechnological products, drugs, and procedures. They oversee recruiting study participants, collecting patient data, creating study documentation and conducting quality assurance audits to ensure study protocols are in order.

Course Name :  TMF and CTMS Documentation
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Code :  CSDT
Duration :  10 Days / 30 Hours
Course Material : This course contains and delivers 5 Lessons.
Each Lesson contains various delivery modes as presentation with voice over, course reading material (chapters), Quizzes for Practice (15 Set) and Test (10 Set), Short Questions, Role based Tasks (Exercises, along with solutions).
Course Brochure : Download BROCHURE
Online Discussion : Book your slot for a personalized ONE-O-ONE discussion with us. You will receive an online invite to participate via email.
Application Form : APPLY NOW
To complete your enrollment, please email your resume to qpdc@qtech-solutions.com

Eligibility

An Associate or bachelor’s degree in life science or other health related. Few of the majors accepted for admission into this course are Medicine, Nursing, Pharmacy, Public health, Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical engineering, Public health, Pharmacology, Toxicology and Healthcare Administration.

Course Enrollment process

Qtech-Sol offers self-paced online courses. Student get started with the course when they are ready. They must complete the online application and pay applicable tuition. Student must submit their resume and copy of highest degree certificate obtained. These documents are used to validate the student’s name on certificate, contact information, course enrolled and their education eligibility to participate.

Start to Finish Steps:
  1. Submit Online Application and email your resume.
  2. Pay applicable tuition (Shopping cart).
  3. Receive Course Activation email.
  4. Obtain access to Course and Solution bank (LMS).
  5. Receive support for subject related queries.
  6. Complete all lessons and Obtain Certificate of completion.
Learning Outcome
  1. Upgrading the Knowledge required.
  2. Better Resume Placement for promising jobs.
  3. Low Investment, high learnings
  4. Learn from Anywhere, anytime at your pace.
  5. Job and Title Based Tasks as followed and practiced in industry
  6. Applying Concept into Real-time (Policies, governance, and tools)
  7. Work on Role Based Tasks followed and practiced in industry
Post Training Assistance

Your resume is front face to hiring recruiters and organizations to pre-screen or call for an interview. With competition out in market, does your resume meet the requirements. Contact us to participate in our Post Training Assistance (PTA)” program for resume build, interview narratives, and mock. It is as well important to know, the current hiring organizations in your area, open positions available, salary range, fitness of resume to apply and many more. During this PTA program you will have opportunity to discuss with our course specialist to learn and discover opportunities in small steps. We shall work together as team to achieve this goal.

Professional organizations

Professional organizations and associations are membership-based groups comprised of people working in a similar field. They can be helpful resources for students to learn more about a field, develop connections and discover related opportunities.

Check out World-Wide Clinical Resource Information. Follow the resource links to learn what’s happening around the world on current news and updates about Clinical trials, Regulatory, CDM and Pharmacovigilance.

Curriculum Overview

This course is designed by industry experts meeting job and title-based learnings needed for students and young professionals to get into jobs. The lessons below include theoretical and practical aspect of the role and tasks performed on day-to-day basis, along with exposure to various exercises per industry requirements

Lessons Offered
1. SOP Development

2. Source Documentation, Retention and Compliance

3. Trial Master File (TMF)

4. Trial Master File – QC Management

5. CTMS Track Recording
Other Recommended Programs
Introduction to Clinical Trials

Clinical Trial Good Clinical Practice

Clinical Protocol Design and CRF

Clinical Trial Monitoring

Role of Clinical Trial Investigator

Clinical Trial Audit Process

Planning for Clinical Trials and Tracking

Introduction to Clinical Trials Management

Getting Connected

For additional information please call us on 732.770.4100 or ENQUIRE. One of our course specialists will contact you at earliest possible.