1. The Principal Investigator (PI) and co-investigators will prepare the protocol for the study according to Guidelines from the Research Unit and the Good Clincal Practice Guidelines from the Ministry of Health.

2. The PI will then submit 3 hardcopies and 1 softcopy of the

• DSRB Application form
• IMH Research Form
• Proposed informed consent document
• Questionaires & assessment instruments (if used)
• Recruitment advertising / posters etc. (if used)
• Copy of the grant (for grant applications)

Additional documents that applicants may be required to submit include:

• Financial disclosure statement
• Investigator agreement
• Case report form
• Documentation that the study has been reviewed by other Ethics Committees

3. Handwritten forms will not be accepted.

4. For the industry sponsored trials an application fee of $315 is payable to "Institute of Mental Health". The PI is required to submit one original set and 8 copies of the entire dossier including the Investigator Brochure.

5. Each protocol will be reviewed in detail by at least 1 appointed primary reviewer and the CRC members will also review the protocol during the CRC meeting.

6. The Investigators will undertake the research project according to the Protocol or the DSRB form. The PI must inform the CRC and DSRB in writing of any changes in the protocol.

7. An investigator can seek funding of Research projects by applying to the NMRC/BMRC/NHG Research and Development Fund. The IBG Applications Forms must be submitted to the concerned funding body after approval for the same is given by IMH CRC.

8. Submissions of industry-sponsored trials must include costing i.e. source and allocation.

9. The PI of any Interventional Study should keep the CRC updated of any Serious Adverse Event/Change in the protocol as soon as possible.

10. All Principal Investigators with research projects approved by IMH CRC must provide six monthly progress reports to the CRC on the progress of the research.

11. The CRC will keep record of the progress of the research project.

Upon completion of the research project, the investigators should present their work at a meeting of conference and/or publish in a jornal if possible. Such presentations/manuscripts must also be vetted by the respective Chiefs/Heads of Departments.