Post-trial management involves several important responsibilities including informing trial participants about outcomes, compensating for injuries, monitoring adverse events, retaining and securing trial data, and determining data ownership. Data integrity and preventing misconduct like fabrication, falsification, and plagiarism are also critical. Journals and researchers must have policies for authorship, funding disclosure, managing conflicts of interest, and correcting the record to ensure publication ethics.

1. Post trial management and
Publication
Dr. Ssuna Bashir
Clinical Epidemiology and Biostatistics
MBCh.B (MUST) Msc. (MAK)
Fellowship in Mixed methods Research (MAK)
Email: sbn144@gmail.com Mob. +256775655562

2. Post trial mgt
1. Post trail assess
• Declaration of Helsinki “At the conclusion of the study, patients entered
into the study are entitled to be informed about the outcome of the study
and share any benefits that result from it, e.g. access to interventions
identified as beneficial in the study or other appropriate care or benefit”
• Compensation for trial related injuries and investigational drug related
injuries
• Determine monitoring plan for AEs and response for AEs
• Inform IRB about significant changes about the drug

3. 2. Data integrity
Fabrication and Falsification of data are one of the most serious challenges
to data integrity
Human error also contributes to loss of data integrity
Concern about research misconduct was a primary motivation for a 1990
conference on data management sponsored by the US Department of
Health and Human Services.
Conference summarized the many ways in which the conduct of research
depends on responsible data management.

4. 3.Retention of data
What should be retained?
It may be impractical to store extraordinarily large volumes of
primary data.
At minimum, enough data should be retained to reconstruct what
was done.
How long should clinical records be retained?

5. 4. Sharing of data
This is considered an important part of responsible research.
De-identified data should be shared so that others can verify your
conclusions or analysis
Sharing of personal patient information is NOT a good practice as
noted in Privacy sections earlier

6. 5.Data security
Limiting Access
Locked Paper Records Offices
Limiting access to Paper or Electronic records to appropriate personnel
Password Protection of electronic records
Defined privileges for electronic data users
Firewalls to prevent outside access
Regular Backups and proper archiving

7. 6. Data ownership
Who owns the data that is generated?
Patient? (patient remains the owner of the data)
Institution?
Funder?
Investigator?
Publisher?

8. Ethics in Publication
Research should strive to answer specific questions—not just collect
or mine data
Statistical issues (sample size) are an important part of design to
ensure that the research data is likely to answer the question
IRB approval is required when using human subjects, human tissues,
or medical records

9. Publication Ethics and Data Management/Data
Analysis
Data should be appropriately analyzed
Inappropriate analysis is not necessarily ethical misconduct
Fabrication or falsification of data is always ethical misconduct

10. Publication Ethics and Data
Management/Analysis
Sources and methods of obtaining and processing data should be
disclosed
Data exclusions should be explained in full
Methods used to analyze data should be explained in detail
Post hoc analysis of subgroups is acceptable as long as this is
disclosed
Data Bias should be discussed in all publications of data or analysis

11. Committee on Publication Ethics (COPE)
At the time of writing COPE serves more than 8500 members around
the world with practical tools, e-learning, seminars, and much more.
Many editors and publishers find COPE tools indispensable.
COPE has published two codes of conduct, one for publishers and one
for editors:
• Code of Conduct for Editors
• Code of Conduct for Publishers

12. Research integrity
1. MISCONDUCT
• Research misconduct is defined in the US Federal Policy on
Research Misconduct:
“Research misconduct is defined as fabrication,
falsification, or plagiarism in proposing,
performing, or reviewing research, or in reporting
research results.”
• Investigations may lead to retractions, expressions of concern, or
other sanctions.

13. Misconduct cont……
• The US office of Research integrity has published
“Managing Allegations of Scientific Misconduct: A Guidance Document
for Editors”. The European Association for Chemical and Molecular
Sciences (Eucheuma) has published “Ethical Guidelines for Publications
in Journals and Reviews.”

14. 2. Whistle blowing
• Allegations of suspected misconduct that have specific, detailed evidence to support
the claim should be investigated appropriately, whether they are raised
anonymously or by named “whistle-blowers.” (More reading: Whistle blower’s act)
3. Fabrication, Falsification, and image Manipulation
changes to images can create misleading results when research data are collected as images.
Thus inappropriate image manipulation is one form of fabrication or falsification that journals can
identify
• Specific features within an image should not be enhanced, obscured, removed, moved, or introduced

15. 4. plagiarism
“ORI considers plagiarism to include both the theft or misappropriation
of intellectual property and the substantial unattributed textual copying
of another’s work. it does not include authorship or credit disputes.”
5. Duplicate and redundant publication
“Authors must avoid duplicate publication, which is reproducing verbatim
content from their other publications.”

16. SANCTIONS
• Before considering sanctions editors must consult with their publisher,
particularly for legal advice, and also with the journal owner (for
example, a scholarly society)
• Sanctions should be applied consistently and only after careful
consideration.
• Before imposing sanctions, journals should formally define the
conditions in which they will apply (and remove) sanctions, and the
processes they will use to do this.

17. Research ethics in journal articles
1. human rights, privacy and confidentiality
For manuscripts reporting medical studies involving human participants,
it is suggested that journals require authors to provide a statement
identifying the ethics committee that approved the study, and that the
study conforms to recognized standards, for example:
• Declaration of Helsinki
• US Federal Policy for the Protection of Human Subjects
• European Medicines Agency Guidelines for Good Clinical Practice

18. 2. cultures and heritage
• Editors should be conscious of the ethics surrounding publication of
images of human remains, and should recognize that human remains
are perceived differently in different culture
• Cultural restrictions do exist in some cultures that prevent publication
of the names of deceased people. in Aboriginal Australian culture, this
often extends to publication of photographs or film footage of
deceased persons.

19. Editorial standards and processes
1. Authorship
The list of authors should accurately illustrate who contributed to the work and how
Guest and Ghost authorship
Criteria for authorship
The International Committee of Medical Journal Editors provides definitions of
authors and contributors that are applicable in many instances beyond medical
publishing. It recommends that authorship should be based on the following four
criteria:

20. a. Substantial contributions to the conception or design of the work; or
the acquisition, analysis, or interpretation of data for the work; And
b. drafting the work or revising it critically for important intellectual
content; And
c. Final approval of the version to be published; And
d. Agreement to be accountable for all aspects of the work in ensuring
that questions related to the accuracy or integrity of any part of the work
are appropriately investigated and resolved

21. 2. Funding
Journals should request that authors list all funding sources in an
Acknowledgments section
3.conflicts of interest
editors, authors, and peer reviewers should disclose interests that might
appear to affect their ability to present or review work objectively.
4. Appeals
5. Corrections
6. Retractions and expression of concerns
7. Withdraw of articles
8. Data protection legislation
9. Publication bias (Journal of negative articles)