Clinical research protocols

Clinical research protocol, parts of protocols

1. CLNICAL RESEARCH PROTOCOLS GEETHANJALI COLLEGE OF PHARMACY P.FARZANA 18Z51r0033

2. A complete written description of, and scientific rational for, a research activity involving human subjects. Sufficient information is to be gathered on the quality of the non – clinical safety to conduct the protocol and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought. A protocol is a document that states the reasoning behind and structure of a research project

3. ALSO DIFFERENT DOCUMENT Background Rational Objectives Design Methodology Statistical consideration Organization of trial

4. The study protocol can be viewed as a written agreement between the investigator, the participants and the scientific community. Look for better ways to prevent disease in people who never had the disease or to prevent a disease from returning. The protocols means: - to clarify the research question. - to compile existing knowledge. - to formulated a hypothesis and objectives. - to decide about a study design. - to clarify ethical considerations. - to apply for funding. - to have a guidelines and tool for the research team.

5. PARTS OF THE PROTOCOLS Title page Signature page. Content page List of abbreviations. Introduction/ abstract. Objectives. Background/rationale. Eligibility criteria. Study design/methods.

6. Safety/adverse events . Regulatory guidance. Statistical section ( including analysis and monitoring). Human subjects protection /informed consent.

7. Title page title page introduces the document , its title , precise number , sponsor and author to the reader. Protocols identifying number and date . Any amendment should also bear the amendment number and date.

8. 2 Eligibility criteria Inclusion conditions and exclusion criteria that must be met in are the order to participate in a clinical trial. 3 study design methods The study design section of the protocols should contain a step wise description of all procedures required by the study. 4 signature page . Significance page of all health care professionals in the trail including contact details of participating site, sponsor and sponsor medical advisor if not already given above.

9. 5 . Background rationale All protocols require a section rationale for a protocols and the justification in medical and the scientific literature for the hypothesis being proposed. 6 . content page This help navigation through the document by large number of different people that will be needed throughout the life of the trail. 7 . Objectives Objectives should be stated hypotheses to be tested. Each objectives should have a corresponding discussion in the statistical section.

10. 8. Safety adverse effect and side effect These are the terms commonly associated with drugs . they are used by nurses and doctors, to refers to undesirable effects of a medication on a patient. 9. The statistical section The study objectives and study design elements in the statistical section should be described in the objections section. 10. List of abbreviations All abbreviations used should be listed and defined . Accepted international medical abbreviations should be standardized within each project.

11. 11. Introduction abstract This summary should be only one to two pages long . It should give the reader sufficient information to understand the rationale for the trail. 12. This section includes discussion of subject selection and exclusion proposed methods of patient recruitment.

12. REFERENCES Industry pharmacy II- Clinical research protocols from the articles , niral .