Clinical Protocol by Ekta

8/4/2019 Clinical Protocol by Ekta

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Clinical Research Protocol

Prepared by: Ekta A. SharmaMpharm (QA)1st SEMRoll no. 10

Guided by: Mrs.H.D.SolankiDept. of pharmacology

Dharmaj Degree Pharmacy College, Dharmaj


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Introduction:

The study of protocol is the blueprint thatall researches will follow. A study protocol is adocument that describes in details, the plan for

purpose & function of the study as well as howto carry it out.


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Appendix X

CONTENTS OF THE PROPOSED PROTOCOL FORCONDUCTING CLINICAL TRIALS

Title Page: Full title of the clinical study.

Protocol / Studynumber, and protocolversionnumber with date.

Complete name and address of the Sponsor andcontract research organization.

List of the Investigators, their site locations.

Names ofclinical laboratories .


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Table of Contents:

A complete Table of Contents including a list of allAppendices.

Page number or other locating information of eachsection, including summarytables , figures, andgraphs.

Background and Introduction:a. Preclinical experience

b. Clinical experience


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Previous clinical should be reviewed here .

If this is an entirely new indication, how thisdrug was considered for this should bediscussed.

Relevant information regardingpharmacological, toxicological and otherbiological properties of thedrug/biologic/medical device, and previous

efficacy and safety experience should bedescribed.


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Study Rationale:

It describes the background information relevantto the study design and protocol methodology.

The reasons for performing this study in theparticular population included should beprovided.

StudyObjective (primary as well as secondary)

and their logical relation to the study design.


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Study Design:

Overview of the Study Design

Flow chart of the study

A brief description of the methods & procedures

Study Population:

The number of Subjects required in the study atthe investigative site are mentioned.


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Subject Eligibility:

a. Inclusion Criteria

b. Exclusion Criteria

Study Assessments:Plan, procedures and methods to be described in

detail.


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Study Conduct: Types of study activities like medical history, type

of physical examination, blood or urine testing,electrocardiogram (ECG), diagnostic testing suchas pulmonary function tests.

Dispensation and retrieval of medication, adverseevent review, etc.

Each visit should be described separately as Visit

1, Visit 2, etc. Discontinued Subject: Describes the

circumstances for Subjectwithdrawal.


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Describes conditions where the study will beterminated for non-compliance with the protocol.

Study Treatment: Describe Dosing schedule , administration of

placebos.

If applicable, concomitant drug, their doses,frequency, and duration of concomitanttreatment should be stated.

Study drug supplies and administration.

Details of the product stability& storagerequirements should be provided.


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Dose modification for study drug toxicity

Possible drug interactions Concomitant therapy: The drugs that are

permitted during the study and the conditionsunder which they may be used are detailed here.

If anywashout periods for prohibitedmedications are needed prior to study, theseshould be described here.

Blinding procedures: A detailed description ofthe blinding procedure is given.


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Unblinding procedures:

If the study is blinded, the circumstances inwhich unblinding may be done and the

mechanism to be used for unblinding should begiven.

Adverse Events:

Description of expected adverse events should begiven.

Procedures used to evaluate an adverse eventshould be described.


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Ethical Considerations:

Risk / benefit assessment Ethics Committee review and communications

Statement ofSubject confidentialityincludingownership of data and coding procedures

Study Monitoring and Supervision: A description of studymonitoring policies and

procedures should be provided.


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Case Record Form (CRF) completionrequirements.

Investigator study files, including what needs tobe stored following study completion should be

described.Investigational Product

Management:

product description and packaging The precise dosing required during the study


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Method ofpackaging, labeling

Storage conditions for study substances. Investigational product accountability: Describe

instructions for the receipt, storage, dispensation,and return of the investigational products

Describe policy and procedure for handling unusedinvestigational products.


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Data Analysis:

Details of the statistical approach includingsample size, assumptions , efficacy endpoint andsafety endpoints.

Statistical analysis: Describe the statistical teststo be used, and the methods used for missingdata, non-compliance, and Subjectwithdrawals.


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Undertaking by the Investigator Checking ofCRF

Checking of all the parameters related to the study design,methodology

Checking of volunteer assessment form etc.

Appendices: Copies of the informed consent documents (patient

information sheet, informed consent form etc.)

CRF and other data collection forms A summary of relevant pre-clinical safety information

Any other documents referenced in the clinicalprotocol.


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Defining the study design for the

protocol: Protocols may outline one of several different

types of study designs, some which are describedbelow, that investigators may follow:

a) Case Study: This type of study relies on aliterature review or uses a physicians clinical casesto introduce a clinical abnormality, usually

something rare, new, or something that presents inan unusual way.


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b) Case-Control Study:This study compares

the number of people who had a potential riskfactor in the case group (thosewith the disease)with those who had the same potential risk factorin the control group (thosewithout the disease).

c) Cohort Study:This type of study comparesrisk factors shared between the case group and thecontrol group. This type of study can be prospectiveor retrospective.


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d) Randomized Controlled Trial (RCT):

In this type of study, participants are randomlyassigned, into the control group or theinvestigational group. The control group receivesthe approved treatment; the investigational group

receives the treatment being studied.

e) Blind Studies: participants do not knowwhich group they are randomly assigned to.


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f) Double-blind studies: means that neither the

study personnel who interact with participants, northe participants know who is assigned to whichgroup.

- Another variation of this design is called a

double-dummy study, meaning participantsreceive a mixture of active and inactive product.These study designs are meant to eliminatepossible bias by the participants.


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g) Meta-analysis: This type of study involves

analysis ofmultiple similar studies that areperformed according to a protocol that outlines themethodology to be used.


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References: http://google2.fda.gov/search?q=helsinki+declara

tion&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*

http://www.wma.net/en/30publications/10policies/b3/index.html
http://google2.fda.gov/search?q=helsinki+declaration&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*http://google2.fda.gov/search?q=helsinki+declaration&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*http://google2.fda.gov/search?q=helsinki+declaration&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*http://google2.fda.gov/search?q=helsinki+declaration&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*http://google2.fda.gov/search?q=helsinki+declaration&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*http://google2.fda.gov/search?q=helsinki+declaration&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*


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ThankYou

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Clinical Protocol by Ekta