Medical writing encompasses the development of various documents that communicate scientific and clinical information related to healthcare products, clinical trials, and medical research. These documents serve different purposes and target different audiences within the healthcare and pharmaceutical industries.

1. MEDICAL WRITING DOCUMENTS

2. CONTENTS
PROTOCOL AND ITS AMENDMENTS
INVESTIGATOR BROCHURE
CLINICAL STUDY REPORT
CASE REPORT FORM

3. PROTOCOL AND AMENDMENTS
Objectives
Design
Methodology
Statistical
consideration
Organisation

4. COMPONENTS OF PROTOCOL
General information
Trial objective and
Purpose
Background information
Statistics
Selection and
Withdrawal of Subjects
Assessment of Safety
Treatment of Subjects
Trial Design
Assessment of Efficacy
Quality Control &
Quality Assurance
Direct access to source
data
Data handling and
Record keeping
Publication Policy
Financing and Insurance
Ethics
Supplements

5. INVESTIGATOR BROCHURE (IB)
compilatio
n
Study of
products in
human subjects

6. COMPONENTS OF
INVESTIGATOR BROCHURE
Table of
contents
Summary
Introducti
on Physical,
Chemical
pharmaceutica
l properties
and
formulation Nonclinic
al studies
Effects in
Humans
Summary
of Data&
guidance
for the
investigat
or

7. CLINICAL STUDY REPORT(CSR)
Regulatorydocumentthat
compriseamarketing
application foradrug.

8. COMPONENTS OF CLINICAL STUDY
REPORT
Title page
Ethics
Investigators
and study
administrativ
e structure
Synopsis
Reference list
Efficacy
evaluation
Introduction
Table of
Contents
Appendices
Safety
evaluation
Study objective
List of
abbreviation &
definition of
terms
Investigational
plan
Discussion and
overall
conclusion
Tables,
figures and
Graphs
Study
patients

9. CASE REPORT FORM(CRF)
Clinical data
recording
document
Used in a Clinical study

10. COMPONENTS OF CASE REPORT FORM
P.I
Verificati
on form
Subject
Randomis
ation
form
Adverse
events
Death
form
Off study
Clinical
Laborator
y data
Complianc
e
Medical
History
Concomita
nt
medication
Subject
enrolment
form
Physical
examinati
on
Eligibility
form

11. BY
Jagillapuram Anusha
anushajagillapuram19@gmail.com
ID: 001/0122