Protocol Designing in clinical research

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Presentation Transcript

Protocol Designing : 

A presentation on………. Amol Khedkar B.Pharm M.Tech(biotech) Email: +91-9763921244 Protocol Designing

Protocol : 

Protocol A protocol is a document that states the reasoning behind and structure of a research project Protocol also designed as a document that describes the background, rationale, objectives, design, methodology, statistical consideration and organization of trial. The study protocol can be viewed as a written agreement between the investigator, the participant and the scientific community

Protocol Outline : 

A typical protocol has the following elements: Protocol Outline Title page Background Information and scientific ratiionale Objectives Signature Page Study design Study Population

Protocol Design………. : 

Protocol Design………. Study Procedure Statistical considerations Subject confidentiality Informed consent process Literature references Supplements/appendices

Title Page : 

Title Page Title page introduces the document, its title, precise number, sponsor and author to the reader. Protocol title, protocol identifying number, and date. Any amendment should also bear the amendment number and date. The protocol number must clearly indicate the version number, whether it is final or draft and date of this version.

Title page…….. : 

Title page…….. Full title should include Summary study design Medicinal products, Nature of the treatment (e.g. treatment, prophylaxis, and diagnosis) Comparator Placebo, Indication Patient population Setting(e.g. in-patient, outpatient) Randomized Double blind Multiple studies

Title page : 

Title page 2. Name and address of the sponsor and monitor. Sponsor names and list of responsibilities with agreed allocations 3. Name and title of the person authorized to sign the protocol and the protocol amendment for the sponsor. Generally, Chief investigator for multicentric trial or principle investigator for single center trials. 4. Name, title, address and telephone number of the sponsor medical expert for the trial.

Title page……. : 

Title page……. 5. Name and title of the investigator who is responsible for conducting the trial, and the address and telephone number of the trial site. 6. Name, title, address, and telephone number of the qualified physician who is responsible for all trial site related medical decisions. 7. Name and address of the clinical laboratory and other medical and/or technical department and/or institutions involved in the trial.

Signature Page……. : 

Signature Page……. Signature page of all healthcare professionals in the trial including contact details of participating site, sponsor and sponsor medical advisor if not already given above.

Content page……… : 

Content page……… This help navigation through the document by large number of different people that will be needed throughout the life of the trial.

List of Abbreviations……. : 

List of Abbreviations……. All abbreviations used should be listed and defined. Accepted international medical abbreviations should be used. Project specific abbreviations should be standardized within each project

Compliance Statement………. : 

Compliance Statement………. The protocol should include a statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement.

Protocol Summary/Synopsis : 

Protocol Summary/Synopsis This summary should be only one to two pages long. It should give the reader sufficient information to understand the rationale for the trial, its objective and the methods that will be used to achieve these objective.

Background Information : 

Background Information Name and description of the investigational product. A summary of findings from nonclinical studies that potentially have clinical significance and form clinical trials that are relevant to the trial. Summary of the known and potential risks and benefit, if any, to human subjects. Description and justification for the route of administration, dosage, dosage regimen and treatment period.

Background information…. : 

Background information…. Description of the population to be studied In short the data in this background information should be able to justify the need for this study

Study Objective/Aims……. : 

Study Objective/Aims……. A clinical trial often has both primary and secondary objectives, and these should be identified as such in the protocol. Ideally, no more than 1 or 2 of each should be included in a clinical trial.

Study Design…….. : 

Study Design…….. A description of the trial design should include i. A description of the/design of trial to be conducted e.g. double blind, placebo controlled, parallel design ii. A description of the measures taken to minimize/avoid bias Randomization Blinding

Study design……. : 

Study design……. iii. A description of the trial treatment and the dosage and dosage regimen of the IP. Also, include a description of the dosage form, packaging, and labeling of the IP iv. The expected duration of subject participation, and description of the sequence and duration of all trial periods, including follow up any. v. A description of “stopping rule” or “discontinuation criteria”

Selection and withdrawal of subjects……… : 

Selection and withdrawal of subjects……… Subject inclusion criteria Subject exclusion criteria Subject withdrawal criteria

Treatment of Subjects…… : 

Treatment of Subjects…… i. The treatment to be administered, including the name of all the product, dose, the dosing schedule, the route/mode of administration and the treatment period ii. Medication/ treatment permitted and not permitted before and or during the trial. iii. Procedure for monitoring subject compliance

Assessment of Efficacy : 

Assessment of Efficacy i. Specification of the efficacy parameters ii. Methods an timing for assessing, recording, and analyzing efficacy parameters.

Assessment of Safety : 

Assessment of Safety Specification of safety parameters The methods and timing for assessing, recording, and analyzing safety parameters Procedure for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses.

Statistics……. : 

Statistics……. i. A description of the statistical methods to be employed, including timing of any planned interim analysis. ii. The number of subjects planned to be enrolled. iii. The level of significance to be used iv. Criteria for termination of the trial v. Procedure for accounting for missing, unused, and spurious data.

Statistics…….. : 

Statistics…….. vi. Procedures for reporting any deviation from the original statistical plan form the original statistical plan should be described and justified in protocol and/or in the final report. vii. The selection of subjects to be included in the analyses e.g. all randomized subjects, all dosed subjects, all eligible subjects, evaluable subjects.

Direct access to source Data Document : 

Direct access to source Data Document The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator/institution will permit trial related monitoring, audits, IEC review, and regulatory inspection by providing direct access too source data/documents.

Quality control and quality assurance : 

Quality control and quality assurance Provide assurance on good clinical practice, quality of data collection and refer to monitor and their role.

Informed Consent : 

Informed Consent Informed consent may be defined as a patients being given adequate information about a clinical trial; understanding and voluntarily accepting the terms of a clinical trial and agreeing to cooperate in its conduct.

Data Handling and Record keeping : 

Data Handling and Record keeping This section deals with the database management- data entry and validation and security/storage, rules for handling non-compliant patients, determining evaluable data etc. Also, source data verification, audit, records retention-duration and location.

Financing and insurance : 

Financing and insurance Financing and insurance should be discussed if not addressed in a separate agreement Publication policy Publication policy should be discussed if not addressed in a separate agreement.

Appendices : 

Appendices Based on the protocol relevant appendices as elaborated should be attached Summary of Product characteristics, data sheet for IP Measurement tools and their validation Pharmacy information, shelf lives, dispensing procedure Methods for collecting patient samples, their storage, dispatch and handling conditions

Appendices…… : 

Appendices…… Clinical labs and tests Adverse reaction grading systems for particular safety parameters Scoring systems of efficacy parameters Analysis diagram Declaration of Helsinki Patient and parent/legal guardian consent form Subject information sheet for informed consent Method of recruitment of patients/subjects to the trial

Thank YOU : 

Thank YOU

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