How scientific paper published on the stages of clinical research impacted by the GDPR - Pubrica
                     HOW SCIENTIFIC 
PAPER  PUBLISHED 
ON THE  STAGES OF 
CLINICAL  RESEARCH 
IMPACTED  BY THE 
GDPR
An Academic presentation by
Dr. Nancy Agens, Head, Technical Operations, 
Pubrica  Group: www.pubrica.com
Email: [email protected]
Today's Discussion
Outline Introduction
The Scientific Paper 
Publishes  Choosing the 
Target Journal  What is 
GDPR
Roles and Responsibilities of the Data 
Controller  Strengthening Your Submission:
Conclusion
Introduction
In clinical research, a significant concern focussed to 
 the recently introduced regulations such as General 
 Data Protection Regulation (GDPR) and Health  
Research regulation.
As of health data is concerned in clinical trials,
it is usually classed as Sensitive personal data under 
 the present legislation as well as GDPR and  
sometimes undergoes severe conditions while  
processing in comparison with other personal data  
such as contact details etc.
Contd..
But still, sensitive personal data are broadened to include the biometric 
 and genetic date in specific along with new compliance for such data 
as  suggested by GDPR.
Scientific 
 Paper  For any researcher, publishing their research results is 
 an integral part of their research life.
Publishe
s Writing a research article is not a preferred part for any 
 researcher, and it is known as a tedious and time-  
consuming one.
These difficulties, while writing and publishing the 
 research findings, can be minimized by following 
 specific guidelines and practising the same.
Contd..
1. Choosing  There are several factors while selecting an appropriate 
the Target  journal for publication.
 Journal
Before finalizing a journal, search some of their published 
 articles to ensure whether your study fits their  
requirements.
For example, you may have researched on cancer genetics, 
 but the journal’s area of interest may be on translational  
medicine; hence the editors will indeed not show interest in  
publishing your article.
Contd..
2.Manuscrip After identifying the journal, submission guidelines for  
t  Writing authors to be read once before proceeding further, make a 
 note of allowed word limits, figure formatting and other  
additional requirements.
In recent times, journals prefer graphical abstract, e.g. Cell 
 press; hence these things to be paid attention.
Also, copyright criteria, referencing format and image format 
 followed as per the instruction of the journal.
Contd..
3.Letter to  
the Editor An essential part while submitting the article is 
 drafting the letter to the editor.
Usually, the authors make a blender mistake in  
replicating their manuscript abstract while writing 
 the letter.
The cover letter should clearly state the overall 
 outline and other details the author wishes to  
share with the editor.
What 
is  
GDPR Regulation is in European Union law; it is a legal  
framework that sets guidelines for the d ata 
collection  and processing of personal information.
The purpose of GDPR(Regulation (EU) 2016/679 is to  
protect the individual fundamental rights and freedom, 
 significantly the protection of personal data.
Roles and  
Responsibilit ie The controller is responsible for implementing  
appropriate organizational measures to ensure and 
s  of the  demonstrate processing activity.
Data Controller
The d ata controller responsibilities include 
collecting  individual consent, storing of data, 
managing consent  revoking, enabling the right to 
access.
The controller, first of all, responsible for all the  
principles regarding the processing of personal data.
Not all processing activities are the same.
Contd..
A controller must have a look at all the data processing activity and check whether 
 they respond to principles of personal data processing.
The purpose of data processing activity doesn’t need more involvement
than others.
1.The controller must implement appropriate technical measures to ensure and
demonstrate the performance of processing following GDPR.
2. The data controller must take action for appropriate data protection policies.
Contd.
.
3. To demonstrate compliance controller can use specific elements that help 
 them keep doing, such as previously mentioned approved codes of conduct 
 certification mechanism.
GDPR requires that data controllers carry out an impact assessment (DPIAs) for  
“high-risk processing” and implement measures to mitigate risk.
In turn, data processors required to inform data controllers of any data breach,  
which describe the data protection commissioner (DPC) within 72 hours where  
there is a risk to the rights of the data subject.
Strengthenin Give your research paper a clear vision.
g  Your  
Submission Good journal and scholarly article generally get straight 
 to the point and remain there with a unique logical 
flow.
 Writing an excellent abstract help, you gain the 
first  impression from the readers for your work.
Make sure there are no unnecessary elements included 
 in that section.
Even one single inappropriate statement have a
strength to change the whole meaning of the content.
Contd..
Be clear and robust in your claims and original in your approach, but don’t 
 overfeed the information what your article provides that will spoil the
importance of your findings.
Get many people to read your abstract and provide feedback before you
submit your paper to a journal..
Conclusion
It needs a selection of an appropriate journal suitable 
 for the study research you selected.
Every journal has its Aims and Scope section, read 
 it carefully before sending your document.
If your goals of publishing the research are related to  
academic advancement, you can quickly evaluate the 
 reputation by checking their papers and titles.
Contd.
.
Publishing the research paper in a peer-reviewed journal is an 
 essential activity within the community.
It allows new researchers to network with other experienced scholars, 
 to get your name and increase the chances of publication and  
broader recognition.
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