Steps For Designing And Development Of Protocol

Steps for designing and development of clinical protocol
-Viral Patel
pviral24@yahoo.com

Protocol
Protocol is a nothing but a scientific treatment plan or study plan on which clinical trials are based. It describes exactly what will be done in the trial. It describes reason for study and structure of study in short we can say it is a detail research plan which values in millions of dollar.

Title page of Protocol
The Cover page of protocol should includes,
Title of study
(It is useful to specify full title of study like it should include study design, nature of treatment, medicinal product, comparator and/or any placebo, indication, patient population)
Names, roles and contact details of
Principal Investigator and sub investigator, Sponsor , Medical expert ,Monitor , any CROs , Clinical laboratories or any institution involved , person authorized to sign protocol if different from above.
Protocol Identification number
(If any amendments than it should be specify)
Protocol version date

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2. List of abbreviations and signature page:
(You can provides all abbreviations that used in protocol)
3. Background information :
Name and description of investigational product.
Preclinical data which have significant impact on clinical study and all relevant findings to the study.
Known potential risks and benefits
Dose rational(route of administration, dosage regimen and treatment period etc.)
Specify study comply with which regulatory requirements and/or ICH GCP guidance.

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Reference literature if any.(For more specification on pre clinical data and background information on study)
4.Objectives :
Clearly define the primary and secondary objectives for the study and also describe the purpose of clinical trial.
5.Clinical study design:
Detail description of type of trial to be conducted.

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(Like parallel or cross over, double blinded ,placebo-controlled etc.)
Steps to be taken to minimize bias.(Like randomization and blinding)
Description of all phases of study.(e.g. phase 1/ 2 /3 / pilot study and schematic diagram of study design)
Detailed description of clinical treatment and dosage regimen. Should also specify dosage form, labelling and packaging of investigational product.
Expected duration of subject participation in study or duration of treatment and also follow up.
Discontinuation rules and stopping criteria.

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Accountability of investigational product.
Randomization procedure and code breaking rules.
All possible risks and potential benefits to study subject.
6. Study subject selection:
a. Criteria(Inclusion , exclusion and withdrawal) -
Detail description of Inclusion criteria.
Detail description of exclusion criteria.
(both criteria should be well specified and shouldn’t create any misunderstanding.)

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Subject withdrawal criteria and procedure specifying that.(should be well described ).
b. Treatment of subjects :
How the treatment will be performed, doses and dosing schedule of product, route of administration ,treatment period and follow up period of each group.
Specification on concomitant medication.
Monitoring procedure for study compliance.

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7. Assessment of safety and efficacy :
Specification of safety parameters.
Specify plan and procedure for adverse events recording and reporting .
Follow up after adverse events.
Specification of efficacy parameters.
Detail description of plan and procedure of accessing, recording and reporting of efficacy parameters.

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8. Data collection plan and data access:
Data collection plan
Time point of data collection.
Specify type of instrument and software will be used(if computerise database used).
Steps to be taken for data security.
Methods to be used to maximise data collection.
b. Data access:
Specify who will have access of study data.(For example specify sponsor, monitor , site staff , regulatory and government body will have access of study data)

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9. Statistical method and analysis:
Describe statistical method to be used.
Details of number of patients planning to enrol at each site.
Power of study and reason for particular sample size.
Level of significance to be used.
Procedure for unused and missing data.
Procedure of any deviation of original statistical plan.
Detail specification of interim analysis.
Early termination criteria.
Non statistical method might be used.(Like qualitative analysis)

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Detail plan for statistical analysis of primary and secondary endpoints.
9.(b) Withdrawal/Drop out of study subject
Criteria , procedure and replacement procedure.
9.(c) Stopping and discontinuation rules :
Criteria and procedure.
9.(d) Accountability of product:

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9.(e) Monitoring and Quality control and Assurance :
9.(f) Assessment of safety and pharmacovigilance:
Description and specification of Aes and SAEs.
Recording and reporting procedures.(Which events to be reported and which not)
Methods for assessing , recording and analysing of safety parameters.
Follow up.
9.(g) Ethical consideration in study.

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10. Finance and Insurance detail:
11. Detail of publication policy:
(if not specify separately)
12. Data handling and record retention:

Steps For Designing And Development Of Protocol

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