TSDP tells you about Clinical Study Protocol, protocol synopsis, Compliance with the Regulatory guidelines, and the resources for protocol-designing. For medical writing training solutions, contact us.

1. CLINICAL STUDY
PROTOCOL

2. What is a Clinical Study Protocol?
Clinical Study Protocol:
 Is defined in the ICH E6 Good Clinical Practice as the document that describes “the objective(s),
design, methodology, statistical considerations, and organization of a trial…[and] usually also
gives the background and rationale for the trial”
 Explains the purpose of the study as well as how to carry it out
 Includes some specific things viz., the reason for the study, number of participants, inclusion and
exclusion criteria, details of the intervention or therapy the participants will receive (such as
frequency and dosage), what data will be gathered, study endpoints, and statistical methods

3. Sections of a Protocol
General
information
Background
information
Trial
objectives
and purpose
Trial design
Selection and
withdrawal of
subjects
Treatment of
subjects
Assessment
of efficacy
Assessment
of safety
Statistics
Direct Access
to Source
Data/
Documents
Quality
control and
quality
assurance
Ethics
Data handling
and record
keeping
Financing and
insurance
Publication
policy
Supplements
According to the ICH Good Clinical Practice Guidelines, a protocol should include the following
sections:

4. Protocol Synopsis
 It is a brief outline of the study which enables the investigators, study coordinators, IRB
reviewers and regulatory personnel to acquaint themselves with the study
 It is often used by the investigators while applying for grants or seeking
resources/other support to undertake the study
Key Elements of a Good Synopsis
Design of the
study
Clear
research
question
Study
population
and
intervention
Objectives
and end-
points of the
study
Methodology
of the study
Statistical
methods to
be employed

5. Clinical Trial in Compliance With the Protocol
 As per ICH-E6 guidelines, the investigator/institution should conduct the trial in
compliance with the protocol agreed to by the sponsor and, if required, by the
regulatory authority(ies), and which was given approval/favorable opinion by the
IRB/IEC
 The investigator should generally not implement any deviation from, or changes of
the protocol without agreement by the sponsor and prior review and documented
approval/favourable opinion from the IRB/IEC of an amendment
 The investigator may implement a deviation from, or a change of, the protocol to
eliminate an immediate hazard(s) to trial subjects without prior IRB/IEC
approval/favourable opinion

6. Resources for Designing a Protocol for a Study:
Resources for Designing a Protocol are:
 ICH General Considerations, together with the Section 6 of ICH-E6 guidelines on
‘Good Clinical Practice’, form an internationally accepted basis for preparing a study
protocol
 Protocols for a product studied as an Investigational New Drug (IND) must follow the
format outlined in the IND Content and Format, item 6 "Protocols" section, of the
FDA Code of Federal Regulation
 NIH Protocol Guidelines outline what is required for a protocol funded by the NIH

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