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I'm a medical writer, and recently, I've finished a GCP course. I wanted to know more about regulatory documents such as study protocol, investigator brochure, Informed consent, etc. I wanted to know how they are written and have a look at their formats because I'm interested in this field. Can someone guide me on how to find these documents?
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Hello,
This may be a helpful source of e-learning
Regards,
Alphonce Nsabi Simbila
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Preparation for the series of careers talks through collaboration with students at various academic levels and institutions staff members. Many thanks for all the comments and replies!
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Thank you very much, Gaurav H Tandon and Bulcsu Szekely for your replies and recommendations to read!
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I am a beginner medical/scientific writer and looking for opportunities to succeed in my career, so looking for any advice and support in the process during an ongoing research. Thank you!
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Unless you plan to perform heavy computations, Python will probably be the best choice for you. And I say that as a C++ developper.
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Get in touch for more info.
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interested
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The theme of the above-noted article is comparable to this already published article: An author’s guide to mastering academic writing skills: Discussion of a medical manuscript.
I mean one is not so aware of journals in the discipline of Education and Teaching that may be suited for such scientific content? Or rather journals that bridge the gap between Education and Medicine?
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How many chances of acceptance of a research paper if journals editor send it to review .
Especially for top journal indexed
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If it has passed editorial assessment than the research article has some scope which is required by the journal. After review you may get two options major or minor revision. But here the chances are 50:50 depending on the reviewers comments.
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Hi everyone
Language editing is a major concern for authors who do not have English as their primary language. Problems with grammar, language, and syntax can result in the rejection of manuscripts from international biomedical Journals. The editors and experts often recommend professional editing which can sometimes cost hundreds of dollars. This is not feasible nor affordable for the majority of authors and researchers based in developing countries who do not have sufficient funds or institutional support.
Many online language editing softwares are now available but the better ones have limited functionality for the free version for example Grammarly.
Please share your experience of using online language editing software with their and strengths and shortcomings. I have been Trinka for 4 months now with excellent results and would highly recommend it
It is the world’s first grammar and language enhancement tool is custom-built for academic & technical writing. Its standout features are that it works with the author and goes beyond the grammar and spellcheck to ensure holistic language enhancement.
If you have not tried it yet, Sign up for a free account from this link
Share your experience of other software too
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You can use grammarly
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First generation metrics of publication involved the count of publication number and the number of citations through tools such as the ISI (Now Thomson Reuters) impact factor. Later, other network analysis tools appeared such as SCIMago Journal Rank. More recently, PDF downloads, HTML page views or scholarly and social network activity (cites in Twitter or Facebook) measured by tools such as Altmetrics donuts appeared as a new way to evaluate how our paper has influenced part of the scientific or the overall population. Do you believe that use in social networks will succeed as a new publication metrics?
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I think it helps, but it would not be "the substitute"
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A young patient attempted suicide by taking 63 tabs of carbamazepine 200 mg. she was managed with CRRT - CVVH and discharged 10 days later well and couscous.
data supporting the use of hemodialysis in managing carbamazepine poisoning is increasing, so I am not sure if it is worth publishing or not ( if it has a chance to get accepted for publishing)
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you must publish your findings
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I have 2 comparable cases that were treated with 2 different treatments( both approved for the meant indication) but showed different outcomes. and I think it is better if I present them in one paper for the goal of comparison if needed.
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In my opinion; it would be better to present them in one paper.
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I'm looking for some suggestions from the expert and experienced people in Deep Learning and Machine Learning fields to write a P.h.D research proposal. I'm thinking of choosing a problem in the medical area!.
If anyone has some examples of the research proposal, share it with me.
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Emotion detection using Audio-Visual data with Deep Learning. Mokhaled N. A. Al-Hamadani
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Is there any renewable or updated database or PFD file for easy handling the valid abbreviations of journal names
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A free online resource for finding abbreviations for journal names is
Some journals have changed their names over time. This tool also allows you to trace these name changes.
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Shouldn't current practices regarding plagiarism be revised? What is your opinion?
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Hi. Do we need to ask permission from the related publishers if we want to use tables and figures from journal article or a citation is enough ?
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Since the copyright of an article has to be transferred to the publisher by the author(s) before publication, permission to use a table or a figure has to be requested from the publisher. It must be cited in the legend of the table or figure with reference and "with permission of ...". There is an exception only with public sources, whereby the source must be specified however also exactly.
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Age determination of unknown human bodies is important in the setting of a crime investigation or a mass disaster because the age at death, birth date, and year of death as well as gender can guide investigators to the correct identity among a large number of possible matches.
Do you think that this time can be extracted using the ratio of decay of radioactive carbon that turns nitrogen after death?
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I am writing an article and I need to show some concepts using graphs and pictures.
Is there any software with which I can draw medical pictures? What about concept maps?
Are there any medical websites giving medical images for free and without copyright?
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BioRender might be a good option (https://biorender.io/)
It's an online app that contains a library of pre-made cells, proteins, membrane shapes, organs, lab equipment, etc. that you can drag-and-drop so you don't have to spend time drawing each element of the figure yourself. Saves a LOT of time and the final figures you create are professional-looking. Plus, it's free for educational use.
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TACS is a device that imports frequencies to your brain in order to persuade your brain’s neurons oscillate by them.
Is it possible to enhance the skills of people with usual intelligence and make them smart by importing gamma ray to their brain?
Does the mechanism have long lasting effects?
Have you ever read something about it?
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Yes, such as periodic modulation of excitability, shifts in spike timing, modulation of firing rate, and shifts in the balance of excitation and inhibition.
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As many young doctors widely use the English root of the word in an Arabic style, to produce Arabian English, in this way they use the word (imdayed) in stead of saying he is dead, and thay said ( imsatble) in stead of saying he gots stable.
Could this developed as a new medical language in Arabian countries?
Do you have other examples of the words used by doctors in your countries?
your participations will be appreciated.
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A good observation respected Azzawi Hadi, as this phenomenon is already happening every where; who are non natives English speakers.
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Web of Science owner Clarivate Analytics has purchased a start-up company whose web-browser extension tool helps researchers to find and access journal articles they have legal access to, with one click and even when off campus. The tool, created by the firm Kopernio, is already freely available. Clarivate will integrate it into its Web of Science subscription package.
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Hi Abdallah,
I think it will be very useful. Much of my manuscript writing activities and corresponding literature searches are performed away from my office. So, for me, the ability to peruse muliple collections through one access point would be convenient.
Have a great day!
-Adrian
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Different type of documents required to be submitted to the regulatory authorities?
What would be the terminology used for various reports that are concerned with Post marketing drugs?
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Dear Colleague
I seek for a collaborator for preparing a review article.
Please send me a massage if you have sufficient and enough time and experience in medical writing.
these projects will be about :
1- Skin lesions in liver diseases
2- imaging in infertility
3- imaging in children with hearing loss
4- cochlear implantation outcome in terms of etiology of sensori-neural hearing loss
5- imaging in pulmonary complications of mustard gas exposure
these projects are ongoing and some steps were completed!
regards
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Hi Amin. Your request is not clear. To collaborate in the preparation of any publication it implies a commitment which can be at several levels. To assess the level of commitment of the collaborator it is important to know first which is your role, what are your expectation, what is the aim of the publication, language of publication,expertise of each of the contributors, number of persons involved, order of authors in the publication, who will be responsible for the cost of the publication, publications with images are usually more expensive, what is the material to be used, what type of review article do you expect to write, systematic review need to have a protocol before you start doing it and it is a lot of work, it also requires experienced librarians. For any publication it requires direct access to science information. Will you be doing the literature search and analysis of the literature?. Hope these questions will help you to frame your request which likely will need to be focus on one subject at the time.
The other highly valuable way to collaborate is being a reviewer. Please indicate if it is that what you are looking for.
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Hi all,
I successfully managed to recruit 105 participants from various mental health charities including Mind, Rethink and the Hearing Voices Network to take part in a study on reasoning.
I am currently in the process of writing the study up in a paper but am unclear on the correct terminology to use to accurately describe the sample.  The participants who completed the study (which was over an hour long with no real incentive) were eligible to complete the study if they had ever received a formal diagnosis of schizophrenia. Hence, the participants were all self-identified as having a clinical diagnosis, but very few (N =2) could show proof of the diagnosis. This isn't a particular problem, but I am curious as to how I should phase this in a journal article. 
Ideally, I was aiming for the journal "Schizophrenia Research: Cognition". However, I have yet to find an article that reports using "self-identified schizophrenic disorders".  Does anyone have any suggestions, or has anyone successfully published using a similar sample?
Cheers in advance.  All views and opinions welcome.
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These sorts of questions are often used in epidemiological studies outside of psychiatry and by the Behavioral Risk Factor Surveillance System at the CDC. Whereas people tend to accept the validity of some categories, there is a tendency to reject self-reported, professionally diagnosed mental disorders. Some national surveys in Canada used this approach, and the epidemiological picture was actually quite reasonable (as it is also for conditions such as diabetes and asthma) - see attached. 
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Recently Kathmandu University [Nepal] changed the criteria for promotion of Medical college teachers. University will consider only the articles which is published in PubMed Indexed Journals for promotion purpose. I agree PubMed indexation is the supreme indexation as a Managing/ Chief Editor of a PubMed indexed journal. Then, What is the use of millions of non PubMed indexed journals?. Also, what is the use of other indexations?
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There are similar regulations about publication in indexed journals in the other country too and there are rules for promotion based on the publication but many other rules exist to adjust the effect of publication.
If I got for a summary:
1. PubMed is good for making a paper "Visible"
2. Impact Factor (ISI/Thomson Reuters) is good to show the formal "Usage" of a "Journal" in the literature (not necessarily the IMPACT and not necessarily one paper)
None of these shows the quality or real contribution to science because:
PubMed is mainly consists of MEDLINE and PubMed Central (PMC) and the criteria that any of these two resources use for inclusion of a journal have nothing to do with quality of the published work or the quality of the researcher. For example if you start publishing a journal in biomedical fields and could provide PDF and PMC-XML for your papers, the journal could be indexed in PMC and as the result it will be visible in PubMed. It is similar for MEDLINE, if you could consider some criteria that MEDLINE asks, the journal get indexed in MEDLINE too. I know MEDLINE- or ISI- or PMC-indexed journals that publish any paper after receiving a little money. So, it might be a promotion by payment!
Also it is the 'journal' that gets indexed and indexing the journal does not mean that my 'paper' had good quality.
I think the decision for promotion of a researcher should be based on a multi-factorial evaluation considering contribution of researcher to science or technology or practice (a change even small one), feedback from students, patents, knowledge translation, popularization of science, linking the academia and industry, getting grants from outside the university, continuous education, collaboration with other institutes and research team outside the university, region or even country, etc.
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I would like to know if any Regulatory agencies provide some certificate or approvals to medical writers to become "Authorized medical Writers"
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Check also the EMWA Professional Development Programme (EPDP) in http://www.emwa.org/training.html
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Does it look good to add more than one case in a case report?
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Yes in this case you could name "Case series" ( instead of "case report") your article. Actually, what Nathan said is true, but there are a lot of journals, although with no or low impact factor, accepting case reports or in your case "case series".
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Looking at the growth and interest of people towards medical writing and more and more companies coming forward and developing special setups.
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Thanks
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For an early-researcher advice of this sort is crucial and in many ways can make or break a researchers career. The answer may seem very obvious to some, but a fruitful discussion might serve wonders to researchers who ever wondered this.
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It does not work that way. You do not plan for numbers. You just make as many good papers as you can and aim them for publication in the best journals that will accept them. One paper will turn out to be brilliant, and everyone will call it the "Francis paper". Two will turn out to be good. Three will turn out to be mediocre. Two will be rejected outright. You will be so ashamed of the remaining two, that you never, never let them move off your hard drive.
Now, stop wondering and wander back to your Gastroenterology paper :-)
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Can bad writing let a good/average study down? Can good writing on the other hand even elevate a mediocre study to make it worthy of publication in a higher impact journal?
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Yes, I agree with Dean. Many times I have felt that the effort done by non-Enlish Speakers when working in the medical writing field is not so much valorated by English speaking people. But anyway is part of the job.
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Though H-index seems promising as it gives the idea about impact of a work on science community. I wonder that Impact factor and H-index are connected in some way. How do we calculate H-index?
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Thanks to all.
As Dean has mentioned that IF is popular, despite the fact that it doesn't reveal actual impact of authors. If we talk about practical scenario, in India most of the funding agencies, high profile interview bodies, academic institutes and etc consider the IF as an important criteria to evaluate one's research potential (Plz note that I don't have idea about international status). Now if authors wants to improve their IF then they may have to bear loss on citations because most of the restricted access journals have high IFs. On the other hand, open access journals may help get more citations
but what about IFs then? There may be a few classic exceptions to the point, I have discussed here.
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I am new in writing papers for publication. I am now in the process of searching for a journal which is appropriate for my study. Can anyone suggest what I may do/use? perhaps links, websites?
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Springer has a interesting tool to help authors to find a suitable journal for their research among more than 2,600 publications. Perhaps, it might help you. See - http://www.springer.com/authors/journal+authors/journal+authors+academy?SGWID=0-1726414-12-837833-0
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Does the assessment of published article depend on the journal impact factor or on the content of the manuscript?
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For journals that consider health equity as central to their mission, current impact factor indicators are sorely inadequate. We need to develop new instruments to measure impact of our publishing--both articles and journals--on health and social outcomes. That is, we need to go beyond the research community itself to find out how research is actually influencing policy and practice. MEDICC Review is working with a group of other publishers to explore how such instruments might be developed.
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Can SR's be conducted for other than human studies (clinical trials, PMS, Surveys, etc) .....if yes, it will be great if you can share your experience while doing one or refer some articles here. I have read a lot of literature, but they talk about the major steps....so was looking for practical, real time steps.
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Since I am an evidence-based medical researcher (in advanced oncology), systematic reviews (SRs) (along with meta-analyses and critical appraisals) are my regular tools (including in preclinical research). So let me start by noting that there are two aspects to acquiring the skill set for conducting high-quality systematic reviews: (1) by following the internal guidelines of the EBM authorities, and (2) by detailed study of high quality examples.
SYSTEMATIC REVIEW PROCEDURES: IN DEPTH
You are right to request detailed, practical real-time step-by-step guidelines rather than the loose outer framework of what known as the PRISMA approach. The best of these are:
(1) CDR's Systematic Reviews: CDR's Guidance for Undertaking Reviews in Health Care (3rd Edition)
This excellent detailed handbook of the methods and steps necessary to conduct a systematic review
is from the authoritative Centre for Reviews and Dissemination (CRD) at the University of York who publish the DARE (Database of Abstracts of Reviews of Effects) Database of SRs.
(2) The Joanna Brigg's Institute Reviewer's Manual
Detailed step-by-step procedures, from The Joanna Briggs Institute (JBI) at the University of Adelaide, a
Cochrane Collaboration and the Campbell Collaboration partner.
(3) Cochrane Handbook for Systematic Reviews of Interventions
From the renown Cochrane Collaboration, this is the most detailed but you may find the first two somewhat easier to commence with, then graduate to this handbook for all the advanced refinements, should that prove necessary, as a reference work although it has exceptional riches.
LEARNING BY ARCHETYPE / EXAMPLE
An excellent example of a systematic review of preclinical research is:
Do in vivo experimental models reflect human cerebral small vessel disease? A systematic review.
Written and conducted by Atticus Hainsworth and Hugh Markus at St. George's University of London, this represents a systematic review of in vivo models of cerebral small vessel disease (SVD), and provides in depth information on the the literature search used, the precise search terms, and the inclusion and exclusion criteria, explicitly following the protocol of the Cochrane Handbook for Systematic Reviews of Interventions.
[J Cereb Blood Flow Metab 2008; 28(12):1877-91]
OTHER EXAMPLES
The University of Edinburgh operates the excellent in-progress CAMARADES collaboration that Alison Booth above shrewdly recommended, with which I would wholeheartedly agree. Their Protocols for Systematic Reviews of Animal Studies page includes several fine examples:
plus some detailed monographs:
PRESENTSATIONS AND MODEL PAPERS
In addition Malcolm Macleod, mentioned by Alison above, has done pioneer work in SRs in animal models of stroke, and he was the keynote speaker at an International Symposium on Systematic Reviews in Laboratory Animal Science sponsored by SYRCLE (SYstematic Review Centre for Laboratory animal Experimentation) at Radboud Univeristy Nijmegen Medical Centre in The Netherlands. The presentation is available
and I think must reading is the SYRCLE authors' paper on:
A step-by-step guide to systematically identify all relevant animal studies
which provides exceptional and detailed step-by-step guidance and examples on the search / identification phase of preclinical systematic reviews:
Constantine Kaniklidis
Director of Medical Research,
No Surrender Breast Cancer Foundation (NSBCF)
European Association for Cancer Research (EACR)
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What is the concept behind publishing study protocols for trials and meta-analyses before their actual conduct?
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Okay. Thank you for the explanation. :)
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In a thesis/dissertation of 20,000 words limit, how can we justify the word count under 5 main headings?
In medical related topics its difficult to cope with the word count as there is not much to write about the body part involved or the treatment being used. I was not provided with any word limit per section, but what I found online was
Introduction & rationale = 1000 words
Literature review = 4000
Methodology = 3000
Data gathering and analysis = 9000
Discussion and conclusion = 3000
Isn't data gathering a part of methodology section and analysis a part of result section? My results analysis section has graphs and tables in it and 9000 words are too much to write even if all tables are discussed separately.
Which section can be used to increase word count from 17,000 to 20,000?
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It all depends on the problem of research and to some extent the branch of knowledge in which the research is being carried out. Even in some disciplines like mathematics, sometimes even this limit of words is also not applicable.
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The discussion may be the most important component of any scientific article. Unfortunately it is the hardest section to write. For biomedical papers is emphasized following axial pattern of a discussion:
1. Generalizations, principles and relationships shown by the results.
2. Highlighting of execptions or any lack of correlation.
3. Presentation of own data, results with their comparation with previously published works.
4. Demonstration of the theoretical implications and as well as any possible practical applications.
5. Conclusion.
What are your personal tips for a powerful discussion?
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From my own little experience: a discussion is powerful when it achieves the following:
1. Focusing on your results and comparing your work with the most updated previous studies --- comparing with relatively old references will weaken the work --- I saw some historical references and obsolete opinions.
2. Targeting to the aim of the work and presenting new explanation to a specific (subject) based o your own experience --- this will be more beneficial for any researcher or specialist --- your personal experience.
3. An excellent discussion is the result of an excellent choice of the subject and its success will validate your whole work and will promote others to continue in the same aim after you .... specially when the results are of value.