dear friends welcome to this session allof you by now have gone through thebasics of research in terms ofconceptualizing the ideas study designsethical and scientific contact ofresearch I'm sure now you are ready togive life to your research ideas in theform of a concept paper I'm going tointroduce to you how to prepare aconcept paper for research projects atthe end of this session you will be in aposition to write a concept paper for aresearch project now let's revisit theseven steps of a successful protocolthese are logical sequential andessential steps the steps includeidentifying research topic framingresearch question objectives and thenmoving on to outlining a one-pageconcept paper preparing dummy tables asper the analysis plan writing a detaileddraftprotocol preparing instruments andannexes including information sheetconsent form and other things related tothe study protocol submit this to acompetent peer review committee andfinally seek review by an ethicscommittee let's look at the lifecycle ofresearch and how these steps areimportant relation to the lifecycle ofresearch you will see that we started westart with identifying data needs and weend with requiring more information thatnecessitates for the research sotherefore the concept paper has tocapture all of these elements in aminiature form of a protocol we aretoday in the second step how do weoutline a one-page concept paper you maywonder why one pitch and there is areason for itthe time for everybody is very preciousfor you for your faculty for your guidesfor your reviewers time is preciousequally the funding agencies are alsohard pressed for time so a one-page in ashorter version forces you to be focusedmany of our ideas just are not born theyremain as ideas one page to write a onepage as compared to a long detailedprotocol may help us in overcoming theinhibition that we have in writing adetailed protocoltherefore the ideas may be born ratherthan getting aborted that's the reasonfor one page I'm going to now outlinethis one page what it requires in bulletstyles in each of the sections of theconcept paper it has these sectionswhich is essentially as I said earlier aminiature of the protocolit has section on background andjustification statement of objectives asa separate section the third sectionexpected benefits key references andbudget I'm going to elaborate on each ofthese sections let's begin with lookingat background and justification thebackground justification essentiallywill have three bullets one on theimportance of the study problem secondwhat is known and unknown about theproblem in relation to the literatureand in relation to the local contextlastly the information that is needed toaddress the problem we effectively nowlet's look at the statement ofobjectives in the concept paper we wantyou to state not more than two or threeobjectives if needed you may have tosplit them as general and specific as wehave discussed in the earlier session onresearch questions and objectives youneed to indicate which is your primaryobjective and which are your secondaryobjectives this is very critical becausethe objectives givegaretty to the reviewers about yourresearch process the next section is onmethods it has to give by bullets anoutline of all the aspects of methodscovering for example study design studypopulation key operational definitionsthe sampling methodology by which youwill select your study participants thecalculation of sample size and keyconsiderations for sample size the datacollection procedures who will collectwhat will they collect and an analysisplan around the key objectives finallythis section will end up by saying whatare the ethical issues and which ethicscommittee will review this protocol ifdeveloped the next section is onexpected benefits as you have listenedfrom the earlier session the researchquestion is is to be answeredthere are two aspects of benefits thatwe look forward in answering theresearch question one what action willbe taken following the results secondwhat is the future research or planningor policy agenda as a result of thesefindings this is very important from theconcept paper point of view you have toset out this in this section and finallyyou need to show that you have masteredthe literature this key references maybe referred to in the introductionsection and may be needed to refer tosome operational definitions in themethod section a citation of a referencewe suggest that you do not put in morethan five offenses however we recommendstrongly you follow internationallyacceptable standard guidelines forwriting these references we recommendyou to adopt and use InternationalCommittee of medical journal editorsguidelines which is accepted globally bymany biomedical journals the lastsection is on budget you may wonder whybudget is important in this conceptpaper but it is equallyto technical and other aspects ofpreparing a concept paper this is anindicator budget it need not havedetailed justification it can cover keyitems like salaries per diem travelequipments and supplies andmiscellaneous whatever is applicable tothe conduct of the research that you areproposing many research agencies insiston having a an indicative budget so thisis also equally important let's look atsome of the aspects of application ofthis concept if you look at IndianCouncil of medical research the premierMedical Research agency in the countryICMR on its home page offers funding forresearchers like you and me there is aprovision called extramural funding onits home page and you will see on thehome page there is a provision to submitwhat they call as pre proposal form itthis is similar to concept paper thispre proposal form it covers thefollowing a title and introduction andnovelty applicability and description ofthe project you will see that they havespecified word count for each of thesesection now if you see the outline thatwe provided most of this can be takenfrom the concept paper that we just knowgenerally concept people that we justknow are provided you except maybenovelty you may have to write it as in afresh section the ICEA mark is alsopromoting research culture among medicalundergraduates they are offering what iscalled short term studentship formedical undergraduates in India theycall it sts proposals the format for stsproposal the preliminary one goes likethis it has a title introductionobjective methodology implications andreferences this looks exactly similar tothe generic format that we just nowrecommended the implications issomething similar to the expectedbenefits that we just now discussedso what we are recommending is that manyIndian other Indian and internationalagencies accept this pre proposal orconcept note or concept paper as a firststep before awarding funding to theresearches this first step helps them inscreaming the proposal for itsworthiness married to award the funds infact some of the research fundingagencies even fund and supportdeveloping a concept paper if it ismeritorious to a full fledged protocolthrough their own funding so ready handyconcept paper is very useful to submitto such research funding opportunitiestherefore what can you achieve with aone-page concept paper it helps you toorganize your ideas find just rightwords in a brief but succinct manner andthat helps you to stand out in thecompetition you may receive rapid andpositive response for your benefit inthe reading section you will find atemplate concept paper one-pagera word document which you may use forwriting your concept paper second wehave also provided a sample conceptpaper now we are going to look at twotemplates of concept papers one forwriting observational studies anotherfor interventional studies I am going toshow them and go through the parts ofthese two templates the first one is onobservational studies as you can see youcan type your title of the project youcan type your name the first section isabout background and justification andwe have provided tips you can actuallyover write on these three bullets thefirst bullet is about the context of thestudy problem in a quantified mannerwithreferences the second bullet is aboutthe local context in which what we knowand what we don't know is stated thethird bullet is in terms of whatinformation we need to manage theproblem effectively you can just overwrite on these three bullets the nextsection is about statement of objectiveswe have some tips here you need to statethem quantitatively for the primaryobjective and you may make it clearwhether you want to propose to estimatea quantity or test hypothesis dependingon the nature of the research questionand statement of the objectives which wediscussed earlier and last but veryimportant you need to clearlydistinguish the secondary objectivesfrom the primary objectives the nextsection is an elaborate section onmethods as we discussed it should be inbullets and you can derive some tips forthe type of study design from thiswidely accepted guidelines available inthis website equal to - network or G youcan state the study population you canstate the study design in one bullet itcould be in terms of observational studydesigns it could be a survey it would becase control cohort studies orecological studies or sometimes it couldbe you know even case report of caseseries depending on the study designthat you choose based on the objectivesthen operational definitions you need toprovide key definitions only and here iswhere as I discussed earlier you canmake a reference to the standarddefinition from the literature criteriayou can even state control recruitmentstrategy for a case control studysampling procedure you can state in onebullet sample size you can brieflymention the sample size and theassumptions data collection unit as Isaid you need to spend spell out whowill collect the data what kind of datathey will collect and within what timeframe and briefly the quality assurancethat is going to be usedfinally the analysis plan you need tosummarize the type of analysis based onthe primary and secondary objectivesyou may mention laboratory analysis ifthey are part of your study humansubject production you may have tomention about key measures that aretaken to ensure the production of thehuman participants and which ethicscommittee will review this proposal andlast but important section is onexpected benefits you need to describethe report that will be generated andthe outcome of this study in order tomanage the problem study problemeffectively in the area where the studyis collected the references the fiereferences you can even make it smallfont size but I've heard to the standardguidelines which we recommend that youuse I see MGK links finally the budgetsection in a brief four bullets okay sothis is on observational studies so wewill have a loud look at a concept paperfor intervention studies forintervention studies the background hasto state what is known and unknown forthe drug or interventions or managementof the specific study problem that youare talking about and you need to saywhy the information currently availableis insufficient you need to state theobjectives clearly here in terms ofprimary objective which we'll look atthe primary outcome in terms of methodsyou may benefit from using theguidelines that are available forwriting a clinical trial protocol so youmay use the elements from that guidelinewhich is called spirit the methodsection is pretty much similar exceptthat you need to state in the clinicaltrial concept paper specificallyinterventions the drug or interventionalits dosage frequency in nature and allthe other forms of interventionsoperational definitions you may have tostate the primary and secondary outcomesyou may have to state the participantrecruitment strategy the next importantsection is on randomization sequenceallocation and allocation councilman youhave to briefly mention the type ofrandomization methods used to generatean employeein the allocation and masking has tomention as to the level and the type ofmasking the other sections are prettymuch similar to what we saw in theconcept paper template for observationalstudies we have a sample out there inthe reading section please miss make useof it while writing your concept paperswe hope you will benefit by making useof it and make writing concept paper ahabit and we wish you give birth to yourideas wish you all the bestthank you