What is a clinical trial protocol? Clinical research is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. An Investigator is selected by the sponsor to conduct a clinical trial. An Investigator should be qualified but they don’t necessarily need to be a physician, although a medical professional should be listed as a ‘sub-investigator if that is the case.

1. Presented by-
Mr.Nitin R. Kale
M.Pharm 1st Year
Subject: P’colgical & toxicological screening method-2
Rajarshi Shahu College Of Pharmacy, Buldana.
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2. CONTENT
Clinical trial
Trial protocol
Content of trial protocol
Investigator
Responsibilties of investigator
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3. CLINICAL TRIAL
 Clinical trial means a systemic study of new drugs in human being
(subject) to generate data to determine pharmacological actions,
adverse effect and safety & efficacy of new drug.
 Clinical trial generate high quality data for healthcare decision
making.
 In clinical trial random assignment of volunteer to control group or
group receiving the experimental therapy in optimal method.
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4. TRIAL PROTOCOL
 Protocol, a written predefined procedures method of conducting
experiments.
 It describe the rational for the trial.
 Therapeutic effect.
 Types of clinical trial
phase-1
phase-2
phase-3
phase-4 (post marketing surveillance)
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5.  Phase 1
First stage of testing in human subjects.
Designed to acess the safety, tolerability,
pharmacokinetics,pharmacodynamics of drug.
20-25 healthy volunteers; Duration:6/12 months
The aim of phase1 trial is to determine the maximum tolerated dose(MTD)
of the new treatment.
Kinds of phase:
 SAD: single ascending dose studies.
 MAD: multiple ascending dose studies.
 Food effect: investigate difference in absorption caused by food.
Limitations :
 Trial restricted to homogeneous subjects.

6.  Phase 2:
It is therapeutic exploratory trial consist of 20-300 subjects.
To confirm effectiveness, monitor side effects & further evaluate safety.
Durations: 6months to several years.
Optimum dose findings:
dose efficacy relationship
therapeutic dose regimen
duration therapy
frequency of administration

7.  Phase 3:
Sponsor: expert comitee review of efficacy, safety and potential
sales.
To file new drug application with DCGI(Drug Controller General Of
India).
Expert review by DCGIs comitee.
DCGI approval.
NCE marketed phase 4 begins.
 Phase 4:
Post marketing surveillance (PMS).
No fixed duration/ patient populations.
Helps to detect rare ADRs, Drug interactions and also to explore
new uses for drugs.

8.  Periodic safety updates: To be submitted by the manufacturer every
6 months for two years and then annually for next two years after
marketing approval.
Harmful effects discovered may result in drug being no longer sold,
or restricted to certain uses.
Confirms the efficacy and safety profile in large populations during
practice.
Detect the unknown/ rare adverse drug reactions.
Identifications of new indications.
Reporting of ADR.

9. 1) General information
2) Objective & Justification
3) Ethical consideration
4) Study design
5) Inclusion, Exclusion & withdrawal of subjects
6) Handling of product
7) Assesment of efficacy
8) Assesment of safety
9) Statistics
10) Data handeling & managements
11) Quality control & quality assurance
12) Publication policy
13) Evaluation
14) Supplementaries & appendices
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10.  General information:
protocol title, protocol identifying no. & date.
 Name & title of person authorised to sign the protocol.
 Name, title address and contact number of investigator, which
responsible for conducting study.
 Name, address and contact number of the institution.
 Objective & Justification:
 Aim & objective of study.
 Name and description of investigational product
 Description & justification for route of administrations.
 Dose frequency & treatment period for the pharmaceutical
product
 Reference to the literature & data that are relevant to the
study.
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11.  Ethical consideration:
 general ethical consideration related to study.
 Study design:
 Description of type of study (random, comparative, blinded)
 Inclusion, exclusion & withdrawal of subject:
 Specification of subject including age, gender.
 Handling of product:
 to ensure about safe handling & storage of pharmaceutical product.
 The label should be necessary contain the following information.
 The word – “ for clinical study only” , Name & code number of study,
 Name & contact number of investigator, Name of institutions subject
 identification code.
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12.  Statistics:
 Description of statistical method to be employed.
 Procedure for managing missing data ,unused data & unauthentic data.
 Assesment of efficacy:
 Description of how effects are measured and record.
 Description of special analysed test to be carried out.
 Assesment of safety:
 Procedure for eliciting reports for recording ADR/ adverse events.
 Information on establishment of study code, where it will light & when how it can
 be broken.
 Data handeling & management:
 A statement “ the investigator /institutions wil permit study related monitoring,
 audits,ethics ,comitee review and regulatory inspections providing direct acess to
 source data / documents.
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13.  Quality control & Quality assurance:
 A meticulous and specified plan for various steps & procedures for
purpose of controlling and monitor the study effectively.
 Specifications and instruction for anticipated deviation from protocol.
 Allocation of duties and responsibility with research team and then
coordination.
 Finance & Insurance:
 All financial aspects of conducting and reporting a study arranged
budget mode out.
 How expenditure should be distributed , e.g. payment to budget
refining express of studies, purchase for apparatus, payment for
investigator.
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14.  Publication policy:
 A publication agreement should be described in protocol.
 Evaluation:
 A specified account for new response to be evaluated
 Methods of computations & calculations of effects.
 Description of how to deal with respect about withdrawn / out of study.
 Supplements & Appendices:
Documents should be appended with protocol.
 Information to study subjects and providing it.
 Instructions to staff.
 Description of special procedures.
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15. INVESTIGATOR
INFORMATION
 An investigator – a person who is responsible for conducting clinical
trial site.
 If a trial is conducted by a team of individuals, then the investigator
is the responsible leader of the team and called the principle
investigator.
 Investigator should be qualified, educated, trained, experienced.
 Show all the up-to-date document to IRB/IEC.
 Familiar with investigational products and their use.
 Aware and comply GCP applied regulatory reqirements.
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16. RESPONSIBILITY OF AN
INVESTIGATOR
 Adequate resources :
To ensure that all the person who assiting with the trial informed
about “protocol, investigational product and trial related duties and
functions.”
To arrange adequate number of qualified staff and cacilities for the
trial.
Medical care of trial subject:
Ensure that adequate medical care will provided for any ADRs
during trial.
Informed the subjects about all the risk and health problem which
can occurred during the trial before they join the trial. 12/15

17.  IRB/IEC approval:
IRB/IEC approval of protocol and informed consent form before
initiation of study.
Be familiar with any national law that may impact study design.
Funding policies and the rules.
Human tissues ( storage, use, transfer to another institutionsor
other country.
Investigatinal product:
It should be handled in appropriate manner.
Packed,label and stored in correct form.
The dose recoed should be maintained.
Includes dates, quantities, batch/serial number, unique code
numbers.
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18. Informed consent of trail subject:
Obtained informed consent form from patients or parents of minor patients.
To ensure patient understand the study.
On going and interactive process between the research team and patient.
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19. Thank You….!
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