Hello everyone,
I can’t believe we’ve already reaching Week 4, on September 3. Topic: Polishing Your Protocol + Tools to Run Your Study.
>>>> BRING YOUR DRAFTS <<<<
Thank you for showing up, taking action, learning how to transforms your careers, and taking your degree further into Clinical Research!
Announcement:
Our Writing Seminar Is Wrapping Up, 2 week left… and Our Clinical Research Career Paths Series Is Coming Up!
If you are Ready to bring your skills into a new industry, gain freedom, balance, purpose, and increase your income, we’ll guide you!
From the ground up, starting with the CRC role and moving into higher executive positions, ensuring you have the tools to become unstoppable in clinical research.
If you are Already a CRC, This is your chance to step into leadership, mentor others, and make a bigger impact.
There’s a place for everyone, but we focus on doctors and those with advanced degrees because higher-level roles come with higher qualifications and requirements and greater opportunities for growth.
💡 Join us and take your career in clinical research to the next level!
Webinar 3 Research Methods:
In research, clarity is everything. A well-written protocol isn’t just paperwork—it’s the backbone of your study.Writing a strong clinical research protocol is the foundation of high-quality, publishable research. In this session, we delve into protocol writing, study design, and reporting guidelines, while demonstrating how to utilize free research templates and a new AI writing assistant specifically designed for clinical research.
Whether you’re designing an observational study, experimental trial, or a systematic review, this video will give you the structure, clarity, and resources you need to succeed.
What you’ll learn in this video:
1-Why is the Methods section the “recipe book” of your research?
2-The difference between observational, interventional, and meta-research studies
3-How to use reporting guidelines from the Equator Network
4-Key protocol elements: ethics approval, eligibility criteria, sampling methods, data collection, and outcomes
5-The role of primary outcomes, composite outcomes, and feasibility studies in protocol design
6-How to avoid bias in sampling and data collection
Replay: https://www.youtube.com/watch?v=o4TgfLPAHg0
Key Point Summary:
The Methods Section – Your Recipe for ReplicationThink of your protocol as a recipe book. Any researcher should be able to replicate your study using the same ingredients (population, criteria, procedures). The most common pitfall: methods are not detailed enough, leaving ambiguity and forcing mid-study improvisation.A solid observational study protocol (the example discussed) should include:
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Ethics approval: state your Research Ethics Board (REB/IRB) and whether informed consent is required.
- Interventional = almost always requires informed consent.
- Observational = sometimes waiver possible (retrospective, low-risk studies).
- Study design: clear description (e.g., “prospective cohort study,” “diagnostic accuracy study”).
- Setting: context matters. Describe hospital type, city, country, and relevant services (e.g., cath lab, oncology services). This helps assess generalizability.
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Participants / Eligibility criteria:
- Inclusion + exclusion must be clear and reproducible.
- Avoid overly broad inclusion—consider prognosis (e.g., exclude patients near death or with advanced, untreatable conditions).
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Sampling strategy:
- Avoid convenience sampling—it introduces bias.
- Use consecutive sampling (“every eligible patient during X timeframe”) or random sampling when feasible.
- Consider day-of-week bias (e.g., some hospitals schedule complex cases on specific days). Rotate sampling days if necessary.
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Data collection:
- Define exactly what, how, and when data are collected (demographics, outcomes, procedures).
- Predefine shell tables to avoid ambiguity.
- Be mindful of who collects data—training and blinding reduce bias.
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Outcomes:
- Primary outcome = one, clearly defined, clinically meaningful.
- Secondary outcomes = supportive, hypothesis-generating.
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Composite outcomes can improve feasibility (by increasing event rates), but use wisely:
- Each component should be of equal clinical importance to patients.
- Each should occur with similar frequency.
- Resource: FDA Guidance on Composite Endpoints
Is the Study Feasable? Can it be done?
Test Before You Scale
Jumping straight into a large, costly trial is risky. Many fail due to poor recruitment, low consent rates, or weak adherence.Feasibility studies help you test the waters:
- Recruit a smaller group (e.g., 20–100 patients).
- Focus on process outcomes: recruitment rate, consent rate, protocol adherence, and timing of data collection.
If you’re a doctor, IMG, or healthcare professional looking to break into clinical research, this video will help you write protocols that are clear, replicable, and publication-ready.
Don’t forget to subscribe for more training on clinical trials, research careers, and growth strategies for medical professionals
Replay: https://www.youtube.com/watch?v=o4TgfLPAHg0
What questions do you have?
Dont forget to introduce yourself and start connecting with other in our community.
Drop the in the FB group so we can get to it faster: https://www.facebook.com/share/g/19z6VPAWGu/
====================================
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
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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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