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CMPP exam prep (ONLY GOT 26 PRACTICE QUESTIONS FROM A PAST EXAM IN 2024) GRADED
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CMPP exam prep (ONLY GOT 26 PRACTICE QUESTIONS FROM A PAST EXAM IN 2024) GRADED
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10/16/24, 9:22 AMCMPP exam prep
Jeremiah
Terms in this set (43)
independent decision making authority responsibly for clinical trials protocols and is
What is the IRB/EC?
responsible for protecting clinical trial participants
Higher transparency
better prioritisation
Why develop a publication plan? (5) neccessary resources allocation
foster collaboration
ensure research is published in ethical, timely and responsible manner
All clinical trial data, including non-interventional
GPP - what should be published?
Key primary and secondary analyses whether postive, negative or inconclusive
SWOT
executive summary
target audience identification
key scientific and communication points
Components of a pubs plan? (9) analyses of journals and meetings
competitor pub and gap analysis
publication strategy
timings
key meeting and journal info
4 stages of pubs planning Planning, initiation, development, submission
Ensures fair balance
Accuracy
Avoids promotional claims or cherry picking data
Why do we need internal reviewers? (6)
Ensure primary objective is met
No overlap with other planned pubs
Ensures authors views are reflected
impact submission timelines
What is the impact of substantial changes
disrespcet authors ownership of content
late in pubs process? (3)
affect relationship with authors/KOLs
impact
submission deadlines
except encores?
acceptance rate
What to consider when choosing a
Fees
journal/congress?
Lead times
Affiliated society
audience
attendance
Not peer-reviewed so not endorsed
ICMJE views on preprints? Should be clearly stated that it is not peer-reviewed and is a preliminary report
Should follow same best practice as full pub
When are pre-prints necessary/useful? When there is an urgent public health need
1/5
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increase impact of research questions
compare research activity for different treatment strategies and find missing
evidence
Benefits of gap analysis (6)
identify new research ideas
see what has already been published
determine key audiences
identify focus area
set limits and defined aim
meanigful timeframe
target sources
Gap analysis process
search parameters
format for output
conduct search
analyse results and define research aims
Should SC members be required to serve no
as authors?
contributor roles taxonomy - used to collect necessary info to decide which
What is CReDiT?
contributors have the greatest ability to analyse and interpret data and be authors
What are the requirements of promotional content should be on-label and follow guidelines and FDA/EU
symposium?
Cochrane collaboration Doesnt allow commercial funding of systemic reviews
Provides authors unique perspective on key area of interest
What is an editorial article? usually not affiliated with the study but will provide context and perspective on
finding of the study
FDA but not requirement
EU clinical trials Regulation - requires PLS to be submitted with clinical study report
Who mandates/endorses PLS?
US writing act
GPP if developed following same ethical and quality principles as main pub
try to publish in peer review
cite publication
How to ensure PLS are not seen as
firewalls so not associated with promo content
promotional? (5)
include all study data so you are not seen to cherry pick
explain regulatory drivers of PLS - EU clinical trials regulation and US writing act
• For clinical studies typically focused on (health) consequences of interventions
• Economic evaluation focuses on costs and consequences = cost-effectiveness
• Defined as ''the comparative analysis of alternative courses of action in terms of
What is CHEERS?
both their costs and their consequences''
• May also be useful for clinical decision-making, pricing, research and development
decision-making
Examples of what does not constitute Acquisition of funding, collection of data (enrollment), or general supervision of the
authorship? research group alone
What to do if authors request removal or journal editors require signed statement of agreement from all authors and author to
additional of another author and be removed/ added
submission/publication?
How to handle author sequence, group or joint authorship and other situations
What should be on GPP authorship
State that authors will not receive payment in exchange for listing their name on a
agreement?
publication byline
2/5
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