A. Materials Submitted: Each application should consist of the following:

? Full protocol include the following:

-Authors

-Name & affiliation of principal investigator

-Name & affiliation of all co authors.

-Role of authors from Mansoura University & other co authors and collaborators

- Introduction highlighting research gap and core results of previous phases of RCT.

- Study objectives: Specific, measurable and time bound -

-Study setting: Time & place of study

-Study methods:

-Study design  

- The way of randomization in details

-The type of blinding

- Full description of intervention

- Full description of study groups Full description of study patients (inclusion & exclusion criteria- sample size calculation (Required for Phase III & IV).

- Laboratory or radiological investigations

-Ethical considerations including informed consent

- Statistical analysis paragraph

-List of updated references

- Name of funding agents

-Statement of conflict of interest

? Consent form (in human subjects’ research) uploaded in IRB system

? Product brochure for new drug/device

- Time plan for the study

- Signed investigator assurance agreement to comply with ethical principles and legal requirements set out in relevant laws and guidelines.

- The payment receipt according to financial statement of MREC.

- An Annual report (developed by MREC)& signed by principal investigators every year until study ends.

B. Clear statement from MREC that the approval of Egyptian drug agency is required after approval of local IRB in Mansoura Faculty of medicine

 NB: the research proposal of the funding agency is uploaded as supplementary file (Department approval documents). However ,the main file created by the principal investigator should be word or PDF uploaded in proposal file.

- The authors should read carefully the national bylaws" Clinical research bylaws no 214 for the year 2020"