Clinical Study

Reports

Dr. Kalpesh Panara

Assistant Professor
Dept. of Dravyaguna
ITRA, Jamnagar
Learning Objectives..

❖ The structure of CSR

❖ content of CSR
❖ Writing CSR
❖ Reviewing CSR.

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 Introduction

❖ A Clinical Study Report (CSR) is a comprehensive and detailed document

that presents the methodology, conduct, and results of a clinical trial.

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ICH E3 Guidelines

• It is structured according to guidelines like the ICH E3 and is a key

regulatory document submitted to authorities such as the FDA, EMA, or
CDSCO for drug approval or new indications.

• The ICH E3 guideline, "Structure and Content of Clinical Study Reports,"

provides a standardized format for clinical trial reports, ensuring clarity,
completeness, and ease of review for regulatory authorities.

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Timeline in Clinical Trials

• Protocol Development

• Ethics Approval

• Trial Conduct

• Data Analysis

• Then finally → CSR Documentation

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Study Reports
 ICH E3 Clinical Study Report Structure – 16 Sections
1. Title Page
10. Study Patients
2. Synopsis
1. Disposition
3. Table of Contents for the Clinical Study Report
2. Protocol Deviations
4. List of Abbreviations and Definitions
11. Efficacy Evaluation
5. Ethics
12. Safety Evaluation
6. Study Administrative Structure
13. Discussion and Overall Conclusions
7. Introduction
14. Tables, Figures, and Graphs
8. Study Objectives and Purpose
15. Reference List
9. Investigational Plan
16. Appendices
1. Overall Study Design and Plan
1. Includes protocol, amendments, CRF samples,
2. Selection of Study Population
ethics approval, patient data listings, etc.
3. Treatments Administered
4. Efficacy and Safety Variables
5. Data Quality Assurance
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Study Reports
6. Statistical Methods
1. Title Page

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2. Synopsis

✓ A brief, structured summary of the essential elements of a clinical trial.

✓ It provides concise and accessible information about the study’s design, objectives,
methodology, patient population, results, and conclusions .

✓ It follows a standardized format, allowing stakeholders to quickly understand the

study’s outcome and relevance without reading the full report.

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 2. Synopsis (Cont.)
Field Details
Study Title A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the
Efficacy and Safety of [Investigational Product] in Subjects with [Condition]
Protocol Number [Enter protocol number]
Investigational Product [Enter product name]

Indication [Disease/condition being studied]

Study Phase [I / II / III / IV]
Study Design [Randomized / Double-blind / Placebo-controlled / Open-label / Parallel / Crossover
etc.]
Study Duration Start Date: [DD/MM/YYYY]
End Date: [DD/MM/YYYY]
Study Sites [Number of centers, locations]

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 2. Synopsis (Cont.)
Field Details
Number of Subjects Planned: [N]
Enrolled: [N]
Completed: [N]
Inclusion Criteria [Key inclusion criteria]
Exclusion Criteria [Key exclusion criteria]
Endpoint(s) [Main measurement outcomes]
Statistical Methods [Brief on analysis methods: e.g., ANOVA, t-test, Kaplan-Meier etc.]
Results Summary - Efficacy: [Brief description of results for primary/secondary outcomes]
- Safety: [Summary of adverse events, tolerability]
Conclusion [Summary conclusion on efficacy and safety based on study findings]

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Study Reports
 4. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS

5. ETHICS
• Independent Ethics Committee (IEC) or Institutional Review Board
(IRB)
• Ethical Conduct of the Study
• Patient Information and Consent

6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE

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Study Reports
Main Body of CSR
7. Introduction

✓ Set the context for the trial based on existing knowledge and unmet needs.
✓ Summarize the preclinical and clinical background of the
investigational product.
✓ State the medical condition/problem targeted.
✓ Research Gap
✓ Establish the basis for the study design and objective.

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 Introduction (Example)
• [Investigational Product Name] is a [class of drug] being developed for the treatment of
[disease/condition].
This condition affects a significant portion of the population globally, with a substantial impact
on quality of life, morbidity, and healthcare systems.

Currently, available therapies for [disease/condition] are associated with limitations such as
suboptimal efficacy, adverse side effects, or lack of long-term disease control.
Therefore, there remains an unmet medical need for more effective and safer treatments.

Preclinical studies have demonstrated that [Investigational Product Name] exhibits [brief
pharmacological or toxicological findings].

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7. Introduction
In earlier Phase I/II clinical studies, the investigational product showed promising results in terms of
safety, tolerability, and initial efficacy in [specific population or conditions].

Based on these preliminary findings, this Phase [II/III] clinical trial was designed to further assess the
efficacy and safety of [Investigational Product] in subjects with [condition], using a randomized, double-
blind, placebo-controlled study design.

8. Objectives
Overall purpose(s) of the study.

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INVESTIGATIONAL PLAN

✓ It details how the clinical trial was planned, designed, conducted, and
analyzed.

✓ It ensures transparency, reproducibility, and validity of the study

findings.

✓ This section is critical for regulatory reviewers, peer reviewers, and readers
to assess the scientific rigor and credibility of the study.

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Overall Study Design and Plan-Description

▪ treatments studied (specific drugs, doses and procedures)

▪ patient population studied and the number of patients to be included.
▪ level and method of blinding/masking (e.g., open, double-blind, single-blind, blinded
evaluators and unblinded patients and/ or investigators)
▪ kind of control(s) (e.g., placebo, no treatment, active drug, dose-response, historical)
▪ study configuration (parallel, cross-over)
▪ method of assignment to treatment (randomization, stratification)
▪ any safety, data monitoring or special steering or evaluation committees
▪ any interim analyses.
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Selection of Study Population

• Inclusion criteria
• Exclusion criteria

Treatments

• Treatments administered
• Identity of investigational product
• Method of assigning patients to treatment groups
• Selection and timing of dose for each patient
• Blinding
• Prior and concomitant therapy
• Treatment compliance
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Efficacy and Safety Variables
• Efficacy and safety measurements assessed and flow chart (laboratory
tests, )
• Appropriateness of measurements (Quality of life- reliability, accuracy
and relevance)
• Primary efficacy variable (and endpoints)

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 Data Quality Assurance

• Training
• Monitoring
• manuals, data verification, cross-checking
• audits

Statistical Methods

• Statistical and analytical plans

-ITT, per protocol
-descriptive, significance, sub-groups, analytical approach (changes from baseline,
EoT, ratio, )
• Determination of sample size
-Effect size, power, error
• Changes in the Conduct of the Study or Planned Analyses
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STUDY PATIENTS

• Disposition of Patients

• Protocol Deviations

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 Results-

✓It is the core of the report, enabling regulatory authorities, clinicians,

and reviewers to assess whether the investigational product was
effective and safe.

✓It presents the data generated from the clinical trial, organized to show
how the study objectives were met.

✓It contains comprehensive, objective summaries of the outcomes

related to efficacy, safety, and compliance, supported by statistical
analyses, tables, figures, and narratives.

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 EFFICACY EVALUATION
Subsection Description
Demographic and Age, sex, race, baseline disease factors, smoking, alcohol, etc.
Baseline Characteristics tables and graphs
• Comparison between group for demographics

Analysis of efficacy Outcomes related to the primary and secondary endpoints, with statistical
analysis
• continuous variables, categorical responses, Tite to Event
• hypothesis testing- Effect size, CI,
• Adjustments for Covariates (Prakriti, Agni etc.) (ANCOVA or Cox
regression)
• Handling of Dropouts or Missing Data
• Interim Analyses and Data Monitoring
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Safety evaluation
Subsection Description
Safety Results Adverse events (AEs), serious AEs, Extent of Exposure

• causality scheme (e.g., unrelated or possibly, probably, or

definitely related).
Clinical Laboratory, all safety-related laboratory Tests
Vital Signs, Physical • hematological tests, liver chemistries, electrolytes,
Findings urinalysis
Concomitant Summary of other treatments used during the trial
Medications
Safety Conclusions Based on need for concomitant medication, serious adverse
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events, events resulting in withdrawal, and deaths.
Study Reports
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Study Reports
DISCUSSION AND OVERALL CONCLUSIONS

It is a critical narrative that provides interpretation, context, and clinical

relevance of the study findings.
Purpose:
➢To interpret and explain the study’s efficacy and safety results.
➢To compare findings with previous research or the standard of care.
➢To acknowledge the limitations of the study.
➢To provide a balanced assessment of the benefit-risk profile.
➢To suggest future directions or recommendations.

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 Key Components…
Component Description
Interpretation of Explain whether objectives were met and how significant the results
Efficacy Results are clinically (not just statistically)
Safety Profile Analysis Commentary on the frequency, severity, and pattern of adverse events
Comparison with Discuss how the results align with or differ from previous studies
Literature
Limitations of the Study Address sample size, protocol deviations, bias, generalizability, etc.
Clinical Relevance Practical importance of findings in real-world healthcare

Future Research Suggestions for further studies or modifications to treatment strategies

Recommendations

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 Reference Section
Category Examples
Scientific Articles Clinical trial results, systematic reviews, pharmacology studies

Regulatory Guidelines ICH E3, ICH GCP, FDA/EMA/WHO guidance documents

Statistical Methods Validated statistical analysis approaches or standard textbooks

Product Information Investigator’s Brochure (IB), Summary of Product Characteristics (SmPC)

Clinical Guidelines Recommendations by WHO, NIH, NICE, AHA, etc. for disease treatment and
diagnosis

Use a consistent citation style such as:

✓ Vancouver style (numbered references – common in CSRs)
✓ APA style (name-year for academic reports)
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 Appendices
Supplementary materials that provide supporting documentation and data
referenced in the main body of the report.
Purpose:
➢To provide raw or supporting data not shown in detail in the main report.
➢To ensure regulatory completeness and GCP compliance.
➢To allow independent verification of analyses and decisions.
➢To maintain transparency and auditability

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Standard Contents of Appendices

Study Protocol and Sample Case Report List of Investigators Ethics Committee
All Amendments Forms (CRFs) and Site Addresses Approvals

Individual Patient
Patient Information List of Patients Who
Data Listings (e.g.,
Sheet and Informed Discontinued the Protocol Deviations
Adverse Events, Lab
Consent Form Study
Results)

Monitoring Visit
Audit Certificates (if Statistical Analysis Reports (optional, if
applicable) Plan required by sponsor
or regulator)
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Points to follow while writing

Plan early and properly: as per regulatory/CRO/other requirements.

Follow ICH E3 Templates: Align with sponsor or CRO templates to
streamline formatting.
Document Assumptions: Clearly state any statistical or procedural
assumptions.
Use Active Voice Cautiously: Passive voice is often preferred for a formal,
objective tone.
Plan for Review Time: Allocate time for internal review, sponsor review,
and regulatory QC.
Write the Synopsis Last: Summarize the finalized report content

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 Best Practices
Category Best Practices
Regulatory Compliance ▪ Follow ICH E3 guidelines strictly.

▪ Use regulatory-agency-preferred templates.

Clarity and Structure ▪ Maintain a clear, logical, and consistent structure.

▪ Use standardized headings and subheadings.

Scientific Accuracy ▪ Ensure data is consistent with the protocol and statistical outputs.

Language and Style ▪ Use professional, objective, and neutral language.

▪ Avoid jargon and subjective statements.

Data Integrity ▪ Ensure traceability of data to CRFs and listings.

▪ Cross-check all figures, tables, and analyses.

Summarization ▪ Provide concise summaries in each section (e.g., Synopsis, Results, Discussion).
Blinding and Confidentiality ▪ Maintain the blind until the database is locked and analyses finalized.

▪ Avoid disclosing subject identities.

Quality Control (QC) ▪ Use independent QC reviewers for checking grammar, consistency, and accuracy.

▪ Use checklists to verify completeness.

Appendices Management ▪ Label and organize appendices clearly and logically.

▪ Include protocols, CRFs,

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Jamnagar, documents
by Dr. Kalpesh Panara in Section 14.0.
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Reviewing Clinical Study Reports
✓Reviewing a CSR is a critical quality assurance step before
regulatory submission or publication.
✓It ensures that the report is accurate, compliant, and clearly
presents the trial findings.
✓A thorough review addresses scientific content, data consistency,
and regulatory adherence.
• Internal Reviews
• Peer Review
• Regulatory Review

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 Key Consideration of AYUSH CSR
✓ Includes standard scientific rigor while respecting traditional knowledge
systems and Ayurvedic diagnostic/treatment paradigms.

✓ Incorporation of standardized and authenticated raw materials (Ayurveda

Pharmacopoeia standards), GMP, D&C act.

✓ Use of SOPs for classical formulation preparation.

✓ Ethical approval from Ayurveda-specialized Ethics Committees.

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