How to write FMT Protocol?

Introduction
An FMT Protocol (also called an FMT Synopsis) is a structured plan for an MD, MS, or DNB thesis in Forensic Medicine and Toxicology that defines your study’s objectives, scope, and methods. A well-written FMT Protocol guides your research steps and ensures institutional approval.

1. Introduction to the Topic

• Define the forensic or toxicological parameter under investigation (e.g., postmortem interval estimation, blood alcohol concentration).

• Specify the context—medicolegal cases, living volunteers, animal models—and the relevance to clinical or legal practice.

• Use both “FMT Protocol” and “FMT Synopsis” to refer to your document.

2. Demographics & Prevalence

• Identify the affected population or case type (age, sex, manner of death, substance use patterns) and cite recent data on incidence.

• Highlight regional or institutional patterns that justify your FMT Protocol.

3. Gap in Existing Knowledge

• Summarize current forensic or toxicological methods and pinpoint unanswered questions (e.g., variability in tissue distribution of a drug).

• Explain how your FMT Synopsis will generate new data to address these gaps.

4. Need and Rationale for Study

• Explain why this research matters for postgraduate training (MD, MS, DNB) and for improving medicolegal investigations.

• Outline limitations in existing protocols or case series.

• State potential impact on case interpretation, courtroom evidence, or public health.

• Mention alignment with national or global forensic guidelines, if applicable.

5. Review of Literature

• Historical Background: trace foundational developments in forensic medicine or analytical toxicology.

• Current State of Knowledge: summarize recent peer-reviewed studies on your topic.

• Key Findings: highlight methodologies (e.g., chromatography, spectrometry) and major results.

• Gaps in Literature: identify what existing FMT Synopses have overlooked.

• Relevance: show how your FMT Protocol builds on and extends prior work.

6. Lacunae in Literature

• List specific shortcomings or under-explored aspects (e.g., stability of biomarkers in different storage conditions).

• Explain how your FMT Synopsis addresses each lacuna.

7. Materials and Methods

• Source of Data/Samples: cadaveric tissues, blood/urine specimens, autopsy records, animal models.

• Study Design: descriptive, analytical, case–control, experimental—state clearly in your FMT Protocol.

• Study Population/Cases: inclusion and exclusion criteria (e.g., autopsies within 24 hours of death; exclusion of decomposed bodies).

• Study Period: precise start and end dates (mm/yyyy–mm/yyyy).

• Sample Size Calculation: present the formula, parameters (expected effect size or prevalence, α, power), and final number.

• Analytical Procedures: step-by-step description of specimen collection, preservation, and laboratory assays (e.g., GC-MS for toxicology).

• Quality Control: calibration procedures, control samples, repeat analyses.

• Statistical Analysis: specify software, statistical tests (chi-square, logistic regression), and significance level (p < 0.05).

8. Ethical Considerations

• Informed Consent: procedures for obtaining permission from next of kin (for autopsy data) or living participants (for toxicology studies).

• Confidentiality: anonymization of case details and secure data storage.

• Risk Minimization: safety protocols for handling biohazards or chemicals.

• Ethics Committee Approval: name of the Institutional Review Board and approval ID.

9. Limitations of the Study

• Sample Constraints: limited availability of certain case types or small numbers of toxicology positive specimens.

• Analytical Variability: inter-laboratory differences or equipment sensitivity.

• Selection Bias: referral patterns to your center or legal constraints.

• Generalizability: applicability of findings to other regions or case populations.

10. Annexures

• Consent Form: template to document informed permission from next of kin or living volunteers.

• Participant/Case Information Sheet: clear summary of study aims, procedures, risks, and benefits for donors or relatives.

• Data Collection Form: structured sheet for recording case details (demographics, circumstances of death, sample IDs) and assay results consistently.

Conclusion
A concise FMT Protocol (FMT Synopsis) tailored for MD, MS, and DNB postgraduate students meets academic standards and provides a clear framework for conducting and presenting your forensic medicine and toxicology research. Cover each section above thoroughly to ensure scientific rigor and clarity.