What are usually the main conditions not met for full approval?

Some of the common conditions for approval for approval not met are:

i) ICF does not contain the applicable requirements according to the Applicant’s checklist of minimum requirements in the informed consent form and written subject information.

ii) Doctor’s name advertised in patient recruitment advertisements and materials

iii) Incomplete document submitted (i.e no indemnity letter)

iv) The coverage of medical fees through healthcare insurance provider in the informed consent form which is not applicable in Malaysia

v) Principal Investigator is not certified in Good Clinical Practice for interventional clinical trials.

vi) ICF are in mixed languages