RECOMMENDED FORMAT FOR A RESEARCH PROTOCOL.

RECOMMENDED FORMAT FOR A RESEARCH PROTOCOL.

1. DISSEMINATION OF RESULTS AND PUBLICATION POLICY

   • The protocol should specify not only dissemination of results and publication in the scientific media, but also to the community and / or the participants and consider dissemination to the policy makers where relevant. Publication policy should be clearly discussed - for example who will take the lead in publication and who will be and acknowledge in publications.

2. EXPECTED OUTCOMES OF THE STUDY.

   • The Protocol should indicate how the study will contribute to advancement of knowledge, how the results will be utilized, no only in publications but also they will likely affect health care, health systems, or health policies.

3. QUALITY ASSURANCE

   • QUALITY ASSURANCE: The protocol should describe the quality assurance system for the conduct of the study , including GCP , follow up by clinical monitors, DSMB , data management .

4. SUBJECT: Investigation Methodology

   • Teacher’s Name: Julio César Díaz Jiménez
   • INTEGRANTES: Giovanni Bautista Guerrero, Andrea Michel León, Jeraldine, F, Karen Bautista Herrera.

5. DURATION OF THE PROJECT.

   • The protocol should specify the time that each phase of the project is likely to take, along with a detailed month by month timeline for each activity to be undertaken.

6. PROBLEMS ANTICIPATED

   • This section should discuss the difficulties that the investigators anticipate in successfully completing their projects within the time frame stipulated and the funding requested. It should also offer possible solutions to deal with these difficulties.