Personalized Covering letter from the Investigator
Completed Application Form for review of research protocol
Copies of the research protocol(including a summary)
Summary of protocol in lay language
Participant information and informed consent document(s)
Curriculum vitae of principal and sub-investigator(s) (Electronic)
Declaration of PI(s) (Only signature page) including Declaration of Storage of Research Data for at least 10 years
Copy of receipt indicating payment of fees to FHS account
Where applicable
LANACOME Approval
Permission to access files/data base at hospital (Retrospective Records Research Information for Clinical Trial / Intervention Research)
Permission to access files/data base at hospital (Retrospective Records Research Information for Non-Clinical Trial / Non-Intervention Research)
Written approval or permission from public health regional authorities to conduct the study at a regional institution(s)
Written approval or permission on official letterhead from relevant institutes, managers, principals and/or directors to conduct the study
Guardian consent form (for subjects under the age of 21)
Minor assent form (for subjects between the ages 7 to 20)
Data capturing sheet(s)
Questionnaires/interview schedules
Insurance Certificate
For a quantitative study with inferential statistics: signed document from a statistician regarding study design, statistical design, sampling details, sample sizes.
Others (Please specify), e.g. Diary cards, advertisements etc.
