| a. |
The
committee will hold regular meetings at least once every
four weeks. When there are no research proposals to
review, the meetings may be held less frequently, but
not less than once every twelve weeks. |
|
| b. |
The
independent ethics committee will follow standards of
Good Clinical Practice. The committee shall reserve
the right to withhold favorable opinion/approval on
a research proposal when the committee does not have
reasonable assurance that the investigator(s) is qualified
and /or that the site facilities are adequate for the
conduct of the study. Confidentiality Agreement will
be signed with the research sponsor before receiving
the review material. |
|
| C.
|
|
| |
The following documents will
be required for submission:
| 1. |
Study proposal (a
covering letter explaining the objective of
the study) |
| 2. |
Protocol and any amendments to
it. |
| 3. |
Written
Informed Consent Form (ICF), including City
amendments and its translation(s) into regional
language (s) |
| 4. |
Written
information to be provided to the subjects
[e,g. patient information sheets (PIS)], if
applicable] |
| 5. |
lnvestigator's
Brochure (IB)/ package insert, as applicable |
| 6. |
Subject
recruitment procedures (e.g. advertisements),
if applicable |
| 7. |
Available
safety information |
| 8. |
Information
about payments and compensation available
the subjects and |
| 9. |
lnvestigator's
current curriculum vitae |
|
|
|
