Title of the study
Institution(s): name & address
Contact information: name, telephone, fax, e-mail
Concise background based on previous relevant research with appropriate references explaining why this study is needed and important.
Aim(s) of the study
A solid hypothesis or target(s) of the study
A detailed explanation of the way the study will be conducted, including, but not limited to, the following headings:
Design of the study (e.g. controlled - non controlled; parallel, cross-over, cohort, etc.; open - blinded; method of randomisation, etc..)
Study subjects (e.g. patient studies, animal studies: inclusion and exclusion criteria, . Laboratory studies: description of material and its selection. .etc.)
Power analysis - number of patients needed to study for predetermined clinically important effect
Basic treatment (e.g. basic care of the subjects - anaesthetic and surgical techniques etc.- Treatment after the study period. etc.)
Experimental treatment (e.g. detailed description of the experimental treatment(s) and the control treatment, drug doses and dosing schedule. How eventual blindness is maintained and how blindness can be broken in emergencies etc.)
Definition of primary and secondary end-points
Measurements and observations (e.g. time schedule of the study and measurements, flow chart of the study; detailed description of measurement methods or references to established methods)
Data processing (e.g. how the study data is recorded; case record form attached if possible. How the data is further processed and analysed. Possible intermediate analyses decision beforehand). Archiving of data. etc.)
Statistical tests (e.g. planned statistical tests: which data is tested how. Reporting of data, etc.)
Safety issues (e.g. observation, measurement and registration of eventual adverse events and how they are treated. Where and how eventual serious adverse events will be reported. Criteria for eventual interruption of the study etc.)
Ethical issues (e.g. ethics committee approval in studies on humans and animal use and care committee approval in animal studies. how eventual changes in the protocol are reported. study done according to principles of Helsinki declaration. etc.)
Patient information and patient consent (e.g. how the patients are informed about the study (both orally and in writing if possible - How the patient consent is documented (in writing if possible). etc.).
Quality assurance (e.g. how participating personnel is informed and acquainted. Monitoring and auditing. etc.)
Estimated milestones of data collection, analysing, reporting and publishing.
Identifying various sources of costs: personnel, material, services etc.
Identifying aimed sources of financing and their status (applied, granted etc.)
How the study subjects and research personnel is covered for eventual accidents and injuries
Following documents should be annexed as enclosures
Statement of the Ethics Committee or Institutional Review Board in case of human studies
Statement of the Institutional Review Board in case of animal studies
A short curriculum vitae (2 pages max) of lead applicant