Research synopsis that passes ethics.
Research synopsis and research protocol writing for your institutional ethics committee (IEC or IRB), university approval and grant applications. Planned to your next IEC/IRB meeting cycle; compliant with ICMR 2017 National Ethical Guidelines and your institution's template.
What a research synopsis & protocol writing involves
The research synopsis is the gatekeeping document for almost every piece of postgraduate medical research in India. Your institutional ethics committee (IEC) uses it to decide whether the study is ethical, feasible and scientifically defensible. Your university or the NBE uses it to register the thesis. Grant reviewers use it to decide whether to fund. Getting it right early saves three rounds of revisions and a year of delay.
We work with postgraduate students, DNB candidates and faculty researchers to draft research synopses and full research protocols that clear IEC review on the first or second round, conform to ICMR's 2017 National Ethical Guidelines, meet your university's template, and - where clinical trials are involved - integrate with New Drugs and Clinical Trials (NDCT) Rules 2019 requirements and Clinical Trials Registry India (CTRI) registration.
Synopsis work is often done under tight supervisor-set deadlines. We plan the engagement around your IEC meeting cycle (typically monthly), so the document is ready for the next submission window rather than the one after.
What this covers
- Synopsis for institutional ethics committee (IEC) review, capped at the word limit your institution prescribes (commonly 2,000 words)
- Full research proposal for university-level committee approval
- DNB thesis protocol in NBE format
- Grant proposal writing (ICMR, DBT, DST, DHR) with the funding body's specific template
- Participant Information Sheet (PIS) and Informed Consent Form (ICF) in English and, where required, a local language
- Assent forms for minors and decisionally-impaired participants (per ICMR 2017)
- Case Record Form (CRF) design for data collection
- Statistical plan with sample size justification referencing your study's primary hypothesis
- Budget and resource justification for grant-funded studies
- CTRI registration preparation for interventional studies (mandatory before recruitment)
- DCGI / CDSCO-aligned documentation for regulated-drug or device trials
- IEC response letter drafting when clarifications are requested
How we work on a synopsis
- 01
Scoping call
We start with a short call on your research question, specialty, institution and the IEC review cycle you are targeting. If your guide has given you a draft or a starting theme, we work from there; if the topic is still being refined, we can fold Research Topic Selection in first.
- 02
Literature brief and background
A structured search establishes the state of the evidence around your question. The background section of the synopsis frames your study against that evidence - what is known, what is unanswered, what your study adds. This is also where the IEC will decide whether the research question is worth the risk to participants.
- 03
Methodology and sample size
Study design, inclusion and exclusion criteria, intervention (if any), outcome measures and statistical plan are drafted against your primary hypothesis. Sample size is calculated with defensible effect-size assumptions and documented inputs. For interventional studies, the study design follows CONSORT; for observational, STROBE.
- 04
Ethics section
Informed-consent processes, participant risk-benefit analysis, data handling, confidentiality, vulnerable-population safeguards and withdrawal provisions are drafted against ICMR 2017 guidelines. The Participant Information Sheet and Informed Consent Form are drafted in English (and a local language where required).
- 05
Compliance attachments
For clinical trials, CTRI registration documents are prepared (registration itself happens after IEC clearance, before first participant recruitment - both timings matter legally). For regulated-drug studies, the additional CDSCO / NDCT Rules 2019 documentation is prepared.
- 06
Delivery and IEC revision round
The synopsis is delivered in your institution's template. If the IEC returns with clarifications (most studies receive some), we draft the response letter and revise the synopsis through the IEC's re-review cycle. Re-review is usually at the next monthly IEC meeting.
What you get
- Synopsis in your institution's prescribed template, within the word limit
- Full research proposal (for grants or university review)
- Participant Information Sheet in English and, where required, a local language
- Informed Consent Form (and Assent Form for minors/decisionally-impaired)
- Case Record Form designed for the specific data you will collect
- Statistical plan with sample size calculation and software inputs
- Budget justification (for grant proposals)
- CTRI registration package (for interventional studies, to be submitted after IEC approval)
- IEC response letter support through one clarification cycle
Standards we follow
The authoritative framework for research ethics in India; every IEC expects synopses to demonstrate adherence.
Regulatory framework for clinical trials of new drugs in India, replacing Schedule Y. Administered by CDSCO.
Mandatory pre-registration of all interventional trials involving human participants in India, before the first participant is recruited.
Apex body under Ministry of Health & Family Welfare governing health-research ethics infrastructure.
International framework for health research ethics, referenced by ICMR 2017 and used by multi-country studies.
World Medical Association's foundational statement on research ethics; the 75th WMA General Assembly adopted the 2024 revision on 19 October 2024, superseding the 2013 version. Cited in nearly every IEC-approved synopsis.
Common questions about synopsis writing
What is the difference between a research synopsis and a research protocol?
A research synopsis is the condensed document (typically capped at 2,000 words by the institution) that summarises the study for IEC and university review: background, objectives, methods, sample size, ethics considerations and references. A research protocol is the fuller operational document that the research team follows during the study: detailed methodology, statistical analysis plan, case record form, standard operating procedures for the intervention, data-handling and monitoring plan. Most Indian medical universities accept the synopsis for IEC review; clinical trial settings and grant reviewers usually require the full research protocol as well. We draft both where the design or funder requires it.
What word limit should I plan for?
Most Indian medical universities cap the IEC synopsis at 2,000 words (excluding references, tables and appendices), consistent with ICMR 2017's synopsis guidance. Some institutions allow up to 3,000 words; a few specialties with complex designs (e.g., clinical trial protocols) ask for a separate fuller protocol alongside the synopsis. We draft to your institution's explicit limit; if the limit is unstated we default to 2,000 words and supply a longer full protocol as an appendix when the design warrants.
Does my trial need to be registered with CTRI?
Yes, if it is interventional (including non-drug interventions and behavioural interventions) and involves human participants. CTRI registration is legally required before the first participant is recruited, per the Drugs Controller General of India's directive and ICMR 2017 Section 7. Observational studies are not mandatorily registered but can be if you wish. We prepare the CTRI registration package; actual registration is done by you (or your institution's trial office) after IEC approval, since CTRI requires the IEC approval letter as part of registration.
Do I need the Informed Consent Form in a local language?
Yes, if any participant does not read English comfortably. ICMR 2017 requires that consent be given in a language the participant understands, with a witness when the participant is illiterate. For most Indian settings that means English plus at least one regional language (Hindi, Marathi, Tamil, Bengali, etc., depending on your patient population). We draft the English version first, then the translation is done by a certified medical translator and back-translated to verify fidelity - a standard requirement many IECs explicitly check for.
What if my IEC asks for revisions?
Most synopses are returned with at least some clarifications - it is a normal part of IEC review, not a sign that the proposal is weak. The common asks are: clarify sample size justification, strengthen participant risk-mitigation, tighten the inclusion/exclusion criteria, add language-specific consent forms, clarify data-handling and storage periods. We draft a point-by-point response letter and revise the synopsis to address each concern. Re-review happens at the next IEC meeting (typically monthly).
Can you handle the budget for a grant application?
Yes, within the structure the funding body specifies. For ICMR, DBT, DST and DHR grant templates we prepare direct-cost budgets (personnel, consumables, equipment, participant reimbursement, publication costs), indirect costs where permitted, and a narrative justifying each line item. We do not guess at institution-specific overhead rates; those come from your finance office. For international grants (NIH R01, Wellcome Trust, Gates Foundation), the structures differ and we work against the specific RFP.
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Medical Thesis & Dissertation
We support MD, MS, DNB and DM candidates through every stage of the thesis - synopsis for the ethics committee, methodology design, data analysis, chapter drafts, viva preparation.
Read more § WritingResearch Topic Selection
Gap analysis against recent literature, feasibility scoring against your specialty, timeframe and institutional resources, and a shortlist your guide can sign off on.
Read more § AnalysisStatistical Analysis
Study design, sample size, hypothesis testing, regression and survival analysis for medical research.
Read moreWhat we don't do.
No ghost-authorship
Your name, your voice, your work. We do not put our names on your thesis or paper.
No publication guarantees
Peer review is not ours to promise. We make the work stronger; the journal decides.
No fixed turnaround promises
Good research takes the time it takes. We scope honestly, not optimistically.
No shortcuts
No AI paraphrasing to game similarity checks. No plagiarism. No sentence-swapping.
Talk to us about your project.
Send over an abstract, a chapter or a rough outline of what you need. We reply within one working day with a clear scope and a fixed quote, no obligation to proceed.