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TrialDoc Elite: Master Clinical Trial Documentation: 

The Comprehensive Training Course For Elite Professionals In The Pharmaceutical Industry

For Institutions only

Are you ready to take your clinical trial documentation skills to the next level?

Our cutting-edge, experiential program will equip you with the knowledge and skills needed to create accurate, clear, and regulatory-compliant documentation.

You'll learn from experienced industry professionals who are passionate about ethical and safe clinical trials. Our program is designed to help you understand the importance of clinical trial documentation in ensuring regulatory compliance and protecting patient safety.

Through our online learning platform, you'll have the flexibility to complete the program on your own schedule. Our simulated case studies will provide you with realistic scenarios that resemble real-world clinical trials, while maintaining the confidentiality of all data involved.

Our interactive learning activities, such as small group discussions and role-playing, will enhance your engagement and facilitate peer learning. You'll be able to apply your new knowledge and skills to your own work, and our pre- and post-tests will measure your learning outcomes.

 We're committed to continuous improvement, which means our program will always be up-to-date with the latest regulatory guidance and changes in the clinical trial landscape. Join us and become a leader in clinical trial documentation today!

Objective 1 

Understand the importance of clinical trial documentation in ensuring regulatory compliance and protecting patient safety.

Objective 2 

Learn the key components and purpose of each document required in clinical trials, including the protocol, investigator brochure, ICF, CSR, regulatory submissions, and PIL.

Objective 3 

Develop skills in writing and reviewing clinical trial documentation to ensure accuracy, clarity, and adherence to regulatory guidelines.

Module 1:

Introduction to Clinical Trial Documentation

  • Importance of clinical trial documentation in ensuring regulatory compliance and patient safety.
  • Overview of the types of documentation required for clinical trials.
  • Role of regulatory agencies in reviewing and approving clinical trial documents.

    • Module 2:

    Designing a Clinical Study Protocol

  • Purpose and key components of the protocol.
  • Best practices for designing a protocol, including study objectives and methods.
  • Common issues and challenges in protocol development.

    • start your journey to becoming a medical writing pro with our online TrialDoc Elite course

    module 3

    Developing an Investigator Brochure

  • Purpose and key components of the brochure.
  • Best practices for writing an investigator brochure, including drug pharmacology, pharmacokinetics, and safety data.
  • Common issues and challenges in investigator brochure development.

    • module 4

    Creating an Informed Consent Form (ICF)

  • Purpose and key components of the ICF.
  • Best practices for writing an ICF, including procedures, risks, and benefits.
  • Common issues and challenges in ICF development.

    • maximize your potential with our industry-leading TrialDoc Elite online Course

    module 5

    Writing a Clinical Study Report (CSR)

  • Purpose and key components of the CSR.
  • Best practices for writing a CSR, including data on safety and efficacy.
  • Common issues and challenges in CSR development.

    • module 6

    Preparing Regulatory Submissions

  • Purpose and key components of regulatory submissions, including the New Drug Application (NDA) or Biologics License Application (BLA).
  • Best practices for preparing regulatory submissions, including adherence to regulatory guidelines.
  • Common issues and challenges in regulatory submission preparation.


    • MODULE 7

    Developing a Patient Information Leaflet (PIL)

    • Purpose and key components of the PIL.
    • Best practices for writing a PIL, including drug information, dosage, and potential side effects.
    • Common issues and challenges in PIL development.

    Continuous Improvement

  • The program will be regularly reviewed and updated to ensure it remains relevant and effective
  • Any new regulatory guidance or changes in the clinical trial landscape will be incorporated into the program materials.

    • unlock your potential in medical writing with our expert-led TrialDoc Elite Online Course !

    join our global community of clinical research experts and innovators today!

    Find out how

    Instructional Delivery

  • Online learning will be utilized to provide flexibility and accessibility for participants.
  • Simulated case studies will be utilized to provide realistic scenarios that resemble real-world clinical trials, with a focus on maintaining the confidentiality of all data involved.
  • Interactive learning activities, such as small group discussions and role-playing, are integrated into the program to enhance engagement and facilitate peer learning.
    • Assessment and Evaluation:
    • Pre- and post-tests will be used to measure learning outcomes.
    • Follow-up surveys will be conducted to assess the impact of the program on job performance and knowledge retention.

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    Course 1

    TrialDoc Elite Online Course

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