What do you need to know before and while working on a clinical trial? This slide deck tells you more about the things you need to remember when preparing to publish your clinical trial, from developing a research protocol and getting informed consent from study participants to registering your trial and preparing a clinical trial manuscript.

1. A GUIDE TO UNDERSTANDING
CLINICAL TRIALS
Created by
PART 2
Things to remember when working
on a clinical trial

2. What did we talk about in Part 1?
THE BASICS
What are clinical trials?
Types of clinical trials
Phases of clinical trials

3. What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript
4
5

4. 1 — Developing a research protocol
Why do you need a research protocol for your clinical trial?
Because it involves human subjects!
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5. A research protocol is a detailed plan, like a roadmap.
What is a research protocol?
It answers specific questions and
safeguards participants’ health
at the same time.
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6. …a clinical trial needs a lot of careful planning.
Since it involves human subjects, it has to abide by
strict scientific standards and ethics that are
designed to protect the rights and ensure the safety
of the patients or participants who enrol for the
trial. Once the research team is clear about the
research idea and study design, it is time to start
developing a research protocol.
Kakoli Majumder
A young researcher's guide to a clinical trial
(available on Editage Insights)
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7. Elements of a research protocol
Background & rationale
of the trial
Informed
consent
Subject selection criteria:
Inclusion & exclusion
criteria
Treatment plan &
study procedures Statistical analysis plan
Assessment of
safety & efficacy
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8. What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript
4
5

9. 2 — Getting informed consent from all subjects
Always get informed consent
BEFORE your trial begins.
Remember
• Be transparent: Provide potential participants with information about
the study so that they are aware of the process, potential benefits, and
the risks involved before they decide to participate in the trial.
• Document: The document providing the details of the trial is known as
the informed consent document. This is what you must share with
participants.
• Exceptions: If your trial includes minor participants or participants whose
decision making capacity is impaired due to clinical conditions, you must
seek consent from a parent or close relative.

10. What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript
4
5

11. 3 — IRB/ethics committee approval
What is IRB?
A US-based committee of physicians, nurses, researchers, statisticians, &
members of the community
Outside of the US, an ethics committee is usually the equivalent
of an IRB.
IRB makes sure that:
 A clinical trial is ethical
 Participants’ rights and welfare are
protected
 Research risks are minimal and worth the
potential benefits

12. What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript
4
5

13. 4 — Registering a clinical trial
Register your clinical trial with a clinical trial registry.
Registry name Link
ClinicalTrials.gov (USA) https://clinicaltrials.gov/
WHO clinical trials registry (global) http://www.who.int/ictrp/trial_reg/en/index1.html
EU Clinical Trials Register https://www.clinicaltrialsregister.eu/
EudraCT (EU) https://eudract.ema.europa.eu/
ANZCTR: Australia New Zealand
Clinical Trials Registry
http://www.anzctr.org.au/
ISRCTN registry (global and
includes trials from Canada)
http://www.isrctn.com/
DRKS (Germany) http://www.drks.de/
Registro Brasileiro de Ensaios
Clínicos (ReBEC) (Brazil)
http://www.ensaiosclinicos.gov.br/
Netherlands trial register http://www.trialregister.nl/trialreg/index.asp
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14. Registering a clinical trial
Some more registries...
Registry name Link
Japan Primary Registries Network • University Hospital Medical Information Network
(UMIN);
http://www.umin.ac.jp/ctr/new-registration/
• Japan Pharmaceutical Information Center - Clinical
Trials Information (JapicCTI)
http://www.clinicaltrials.jp/user/cte_main.jsp
• Japan Medical Association - Center for Clinical Trials
(JMACCT)
https://dbcentre3.jmacct.med.or.jp/jmactr/Default_Eng
.aspx
Clinical Research Information Service
(CRiS), South Korea
https://cris.nih.go.kr/cris/en/use_guide/cris_introduce.jsp
Chinese Clinical Trial Register (ChiCTR) http://www.chictr.org.cn/abouten.aspx
South African National Clinical Trial
Register
http://www.sanctr.gov.za/
Pan-African clinical trials registry
(PACTR)
http://www.pactr.org/
The Clinical Trials Registry- India (CTRI) http://ctri.nic.in/Clinicaltrials/login.php
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15. What next?
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript
4
5

16. Different types of clinical trials follow different
reporting guidelines.
5 — Preparing a manuscript
 CONSORT – for randomized trials
 STROBE – for observational studies
 STARD – for diagnostic studies
Sections of a clinical trial manuscript:
• Title page
• Abstract
• Introduction
• Methods
• Results
• Discussion
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17. Preparing a manuscript
Title page should include the article
title, author information, disclaimers, sources
of support, word count, and sometimes the
number of tables and figures.
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Abstract should include items
identified as essential in the CONSORT
guidelines, and clinical trial registration
number.
Introduction should include
background information about nature of the
problem and its significance as well as the
statement of purpose or research objective.
Methods should include all the
details of how and why the study was
conducted, selection and description of
participants, technical information, and
statistics.
Results should include text, tables,
and figures as well as data on all primary and
secondary outcomes mentioned in the
Methods section.
Discussion should include the main
findings and comparison of results with other
relevant studies, the limitations of the study,
and implications for future research and
clinical practice.

18. Your clinical trial is now ready for journal submission!
1
2
3
Developing a research protocol
Getting informed consent from all subjects
Seeking IRB approval
Registering a trial
Preparing a manuscript
4
5

19. End of part 2
We hope you found this useful.
Here’s the link to Part 1: An introduction to clinical
trials:
http://www.editage.com/insights/an-
introduction-to-clinical-trials-part-1-the-basics
Note: This series is based on the article A young researcher's guide to a clinical trial by Kakoli Majumder,
published on Editage Insights: http://www.editage.com/insights/a-young-researchers-guide-to-a-clinical-trial

20. www.editage.com/insights
@EditageInsights
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