Goodwyn IRB reviews
a proposal by first assessing the risks and benefits of participation.
The sponsor must complete the
Sponsor Application for this review of the
protocol and background documents.
Sponsors must submit the following items:
. Application Form
. Protocol
. Informed Consent form (Suggested)
. Investigator's Brochure
. Copies of any proposed patient recruitment materials (advertisements,
referral letters, screening scripts, etc.)
. Signed Indemnification Agreement
* The DOC file format requires
that you have Microsoft Word '97 or higher installed
on your computer. If you do not, please use PDF format.
** The
PDF file format requires that you have the Adobe Acrobat Reader
installed on your computer. If you do not have this program installed,
you may download and install a free copy by clicking the icon below:
Definitions
Informed Consent form (suggested):
The template, "suggested", written informed consent document
corresponding to a study protocol that describes the study and
its risks and benefits. It is prepared to guide individual investigators
in preparation of their site-
specific informed consent forms.
Investigator's Brochure: A compilation of the clinical
and nonclinical data on the investigational products(s) that
is relevant to the study of the investigational product(s) in
human subjects.
Investigational New Drug (IND): A drug permitted
by the FDA/HPB to be tested in humans but not yet determined
to be safe and effective for a particular use in the general
population, and thus, not yet licensed for marketing.
Investigational Device Exemption (IDE): An
exemption from certain rules found in the Medical Device Amendments,
allowing use of a not-yet-approved device in clinical investigations.
Protocol: A document that describes the objective(s),
design, methodology, statistical considerations and organization
of a trial. The protocol usually also gives the background and
rationale for the trial, but these could be provided in other
protocol-referenced documents.
Sponsor: An individual, company, institution
or organization that takes responsibility for the initiation,
management and/or financing of a study or clinical trial.
