Hello everyone,
I can’t believe we’ve already reached Week 3!
I want to take a moment to congratulate you for showing up for yourself and committing to developing the skills that will elevate your career.
Your consistency and dedication are what set you apart.
Congratulations to Reena for keeping up with the challenges!
Writing research protocols is more than just paperwork—it’s a powerful way to demonstrate your research skills, stand out among peers, and open doors to leadership roles such as:
==>>Medical Monitor 🏥
==>>Director of Operations 🥼
==>>Medical Affairs Specialist 💊
… and many more.
When you master protocol writing, you’re not only proving your ability to think scientifically and strategically—you’re also positioning yourself for career growth and showing sponsors, CROs, and research sites that you can bridge clinical expertise with research execution.
This skill allows you to:
✅ Leverage your medical knowledge in new, impactful ways
✅ Elevate your career into higher-level roles
✅ Reclaim your worth as a physician and global contributor to science
✅ Directly impact patients’ lives across the world
🌍 Doctors and IMGs are uniquely qualified to thrive in clinical research, but too often they’re not shown the roadmap. That’s why we’re hosting a special webinar where we’ll help you:
🔹 Build the skills to write protocols with confidence
🔹 Step into higher research roles
🔹 Unlock opportunities in clinical research and medical affairs
Your medical training already gave you the foundation. Now, it’s time to turn it into influence, leadership, and impact.
📽️ Here is last week's replay:
Week 1 https://lnkd.in/eKdStDbz
Week 2 https://lnkd.in/eWQ47DFy
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Week 2 Challenge:
Write an introduction using the Problem-Gap-Hook approach for a protocol
1) Literature Review
2) Bullet Points Under Problem-Gap-Hook headings
3) Write (+- LLM)
4) Review + Cite
Network Facebook group: https://lnkd.in/edwd9zcB
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Writing the Introduction & Objectives of a Research Protocol
A guide with best practices and how to leverage AI responsibly
1. Why the Introduction Matters
The Introduction sets the stage for your entire protocol. It explains why the study is needed, what gap in knowledge it addresses, and how it aligns with prior research. A strong introduction does three things:
- Contextualizes the problem: Provides background on the disease/condition, prevalence, burden, and current treatment or knowledge gaps.
- Summarizes evidence: Briefly highlights key studies and existing data.
- Defines the rationale: Shows why this study is the logical next step.
💡 Best Practice: Keep the introduction focused and evidence-based. Avoid writing a long textbook chapter.
2. Writing the Objectives
The Objectives clearly state what the study aims to achieve. They provide direction and help define your endpoints.
- Primary Objective: The main outcome the study is designed to evaluate (e.g., “To assess the efficacy of Drug X compared to placebo in reducing HbA1c after 12 weeks”).
- Secondary Objectives: Additional, supportive outcomes (e.g., safety, quality of life, biomarker analysis).
- Exploratory Objectives: Early signals, hypothesis-generating findings.
💡 Best Practice: Make objectives SMART – Specific, Measurable, Achievable, Relevant, and Time-bound.
3. Common Pitfalls to Avoid
- Writing too broad or vague objectives (“to study the effects of Drug X”).
- Mixing methods with objectives (methods go in another section).
- Overloading with too many secondary objectives.
- Forgetting alignment between objectives and study endpoints.
4. How AI Can Support (but Not Replace You)
AI tools can accelerate your protocol writing—but they must not replace your judgment, expertise, and voice.
-
AI Can Help You:
- Generate summaries of background literature (but you must verify citations).
- Suggest draft sentence structures for clarity.
- Create objective templates (e.g., converting vague aims into SMART objectives).
- Provide consistency checks (avoid repetition, ensure alignment between objectives and endpoints).
-
AI Should NOT:
- Replace your critical analysis of the literature.
- Invent data or references.
- Define objectives without your expertise.
- Be the final writer of your protocol (you must maintain scientific and ethical authorship).
💡 Best Practice with AI: Use it as a thinking partner to refine your ideas, but every word should go through your own clinical lens and ethical responsibility.
5. Quick Framework for Drafting
-
Introduction Framework:
- Background (epidemiology, burden)
- What is known (brief literature summary)
- Knowledge gap (what’s missing)
- Rationale (why your study is needed)
-
Objectives Framework:
- Primary Objective: 1 clear statement
- Secondary Objectives: 2–5 targeted aims
- Exploratory Objectives: optional
The introduction and objectives are the foundation of your protocol. Write them with precision, tie them to evidence, and make them clinically meaningful. Let AI help you brainstorm, organize, and polish, but never outsource your scientific authorship.
What questions do you have?
====================================
As part of our Research Protocol Webinar Series with Dr. Ross Prager, we’re inviting you to be among the first to beta test a transparent AI writing assistant built right into Microsoft Word.
This is your chance to:
Try it free before anyone else
See how it can fit seamlessly into your writing process
Get an exclusive discount after the beta if you decide to keep using it
Beta Sign-Up: https://lnkd.in/eBgME-GU
=====================================
Don’t just read protocols—learn to create them.
💥 Let’s reclaim your expertise and turn your words into your next breakthrough.
Week 1 – August 13Topic: How to Start a Research Project
Week 2 – August 20Topic: Writing the Introduction + Objectives
Week 3 – August 27Topic: Methods That Match Your Question
Week 4 – September 3 Topic: Polishing Your Protocol + Tools to Run Your Study
Week 5 – September 10 Topic: Protocol Structure Review
Week 6 - Group Meet-up and Celebration
📌 Disclaimer & Consent
This session is for educational and informational purposes only. It is not legal, regulatory, or medical advice.
The webinar will be recorded. By attending, you consent to your image, voice, and participation being recorded and potentially shared with other students, in educational materials, and on our social media platforms.
🛠 How to Prepare
Bring something to write – You’ll be starting your own project during the session.
Review your questions in advance – We’ll have Q&A at the end, but you can also post in our private Facebook group before or after the webinar.
Test your tech – Make sure your internet, audio, and Zoom (or other platform) are working ahead of time.
Minimize distractions – Find a quiet space so you can focus and participate fully.
Come with an open mind – Whether you’re here to learn protocol writing or explore a career in clinical research, this is a great opportunity to grow your skills and network.
❓ Questions During the Webinar
-->Questions related to the session topic will be answered during the Q&A at the end.
-->Questions about breaking into clinical research or career pathways will be addressed after the main presentation concludes.
Here is the event, enjoy!
Zoom:
https://us06web.zoom.us/webinar/register/WN_Z-vLmK79RFG5WMxYS4qNdw
https://www.linkedin.com/posts/jenniphergonzalez-md-img-clinical-trials-liaison-consultant_this-is-your-invitation-to-reclaim-your-activity-7358205184096772096-7qZe?
See you inside,
Jennipher Gonzalez M.D.
Thank You for Joining Me!
As a dedicated physician and research expert, I aim to empower medical professionals, especially International Medical Graduates (IMGs), to grow and thrive in their clinical research careers. I am passionate about sharing insights and strategies that can help you navigate the complexities of this field and unlock your potential.
I’m thrilled to embark on this newsletter journey with you, where I’ll provide valuable resources, actionable tips, and industry updates relevant to your career advancement in clinical research.
Your feedback is invaluable! Please share suggestions, topic requests, or ideas for future projects and events. I am committed to creating content that meets your needs and drives your professional growth.
Stay tuned for exciting updates, insightful resources, and upcoming events. Together, let’s explore the vast opportunities in clinical research and work towards achieving our goals.
I appreciate your support, and I look forward to this transformative journey with you!
Disclaimer:
The information provided in this newsletter is for general informational purposes only and should not be considered medical, legal, or professional advice. The content is based on the knowledge and understanding available when writing and may not encompass the latest research, regulations, or developments in the clinical research field.
The content of this newsletter is intended for educational and informational purposes only and should not be used as a substitute for professional advice or judgment. It is important to consult with qualified professionals and seek appropriate guidance specific to your situation before making any decisions or taking any actions based on the information provided in this newsletter.
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Jennipher Gonzalez MD
Clinical Research Specialist and Consultant
Empowering Doctors, IMGs, Researchers and Professionals to excel in Clinical Trials and Research!
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