Protocol Clinical Trial
Title of the project
Objective of the study
(Short introduction describing the objective(s) of the study)
Investigator(s)
(Name and coordinates of the investigator(s) + point out the principalinvestigator + the responsible head of the department)
SponsorIf applicable
(Name and coordinates of the sponsor)
Departments/laboratories involved in the study
(Name and coordinates of all departments and laboratories involved in the study)
Introduction
(Describe the rationale for this study. Overview of the literature on the subject.)
Study design
(Describe the design of the study (open, double-blind, randomised,…))
Medication/deviceIf applicable
Composition and dosing
(Describe the complete composition and dosage of the medication)
Producer
(The name and coordinates of the company that produces the compound or device that will be tested)
Distributor
(The name and coordinates of the distributor of the research object (medication/device))
Packaging
(Describe the nature of the packaging of the medication/device)
Storage conditions
(Describe storage conditions for the medication.device)
Known side effects
(Describe already known side effects reported after the use of the drug/device)
Drug accountability
(Document drug accountability)
The subjects
Number of subjects
(Describe the number of subjects that will be included in the study. In case of a multicentre study, provide the number of subjects per centre.)
Inclusion criteria
(Criteria that determine whether subjects are included)
Exclusion criteria
(Criteria that determine whether subjects are excluded)
Replacement of subjects
(Describe the measurements that will be taken when subjects drop out)
Restrictions and prohibitions for the subjects
(Describe the restrictions for the subjects (e.g. no alcohol during the study, no smoking, no medication, adapted diet, …))
Procedures
(Describe all the procedures that will be executed during the study (e.g. ECG, blood samples, biopsy,…) and the address where they will be carried out)
Flowchart
(Provide a systematic overview of the study: planned tests per visit of the subjects + the expected total duration of the trial. Supervising MD during the tests?)
Randomisation/blinding
(Describe the randomisation schedule and/or the procedures for blinding (if applicable). Describe, in case of blinding, the procedures to end the blinding at the end of the trial.)
Prior and concomitant therapy
(Describe the medication that is allowed and prohibited before and during the trial)
Study analysis
Sample size calculation
(Describe the criteria that determine the number of subjects)
Analysis of the samples
(Describe the person (name and coordinates) that will analyse the samples. Also provide the analytical methods that will be used in the trial.)
Statistical analysis
(Describe the statistical analyses and the person that will conduct them (name and coordinates).)
Quality control and quality assurance
(Describe the procedures that will be applied to ensure the quality control.)
Publication policy
(Describe the publication policy of this study: rights of the investigator(s)/rights of the industrial partner?)