Clinical Study Protocol Synopsis Template. Running head: Template Clinical Study ProtocolAbstractThe Clinical Study Protocol is a document which describes how a clinical trial will be conducted. DOSE LEVEL (S) AND DOSE JUSTIFICATION Specify the dose level(s), number of doses, and dosing.
A clinical study protocol is a document that describes the study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data. In order to have a clear roadmap, it is important for the investigator to have a succinct and relevant synopsis that others The synopsis is often used when investigators apply for grants or seek to obtain resources and other support to undertake the study. Included in the protocol is an objective, study design, methodology, statistical considerations as well as statistical organization.
DURATION OF FOLLOW UP Specify the length of the protocol-specified follow up period.
Countries with high mortality/morbidity, with a vaccination. schedule in line with WHO recommendations.
A clinical study protocol is a document that describes the study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data. Included in the protocol is an objective, study design, methodology, statistical considerations as well as statistical organization. Adverse Events Database (template in Access) - courtesy of Neurosurgery.