|
Nature of Question |
CCI Staff Member or Chair |
Email |
Telephone |
|
CCI jurisdiction:
When
is an investigator required to submit to our IRB
What
kind of review is required |
Mary Williams |
mwillia2@bidmc.harvard.edu
|
7-3743 |
|
Meeting attendance and/or presentation |
Susan Yuen-Lee -- West campus
Astrid Joseph -- East campus
Lily Moy -- Continuing review |
syuenle@bidmc.harvard.edu
ajoseph3@bidmc.harvard.edu
lmoy@bidmc.harvard.edu |
7-1831
7-1827
7-4311 |
|
Submission of new applications
(Including questions about informed consent) |
Susan Yuen-Lee
Astrid Joseph |
syuenle@bidmc.harvard.edu
ajoseph3@bidmc.harvard.edu |
7-1831
7-1827 |
|
Continuing review |
Lily Moy |
lmoy@bidmc.harvard.edu |
7-4311 |
|
Educational Requirements |
Michael D'Egidio |
CITIexam@bidmc.harvard.edu. |
7-4524 |
|
Emergency Use requests
**page Alan Lisbon ASAP at 32181 |
Mary Williams
Susan Yuen-Lee
Astrid Joseph
Lily Moy |
mwillia2@bidmc.harvard.edu
syuenle@bidmc.harvard.edu
ajoseph3@bidmc.harvard.edu
lmoy@bidmc.harvard.edu |
7-3743
7-1831
7-1827
7-4311 |
|
Publicity:
What are the CCI requirements for advertising for
recruitment, press releases, speaking directly with the press |
Astrid Joseph |
ajoseph3@bidmc.harvard.edu |
7-1827 |
|
Investigational Drugs/Devices:
What kinds of approvals are required for use in clinical
trials |
Mary Williams |
mwillia2@bidmc.harvard.edu
|
7-3743 |
|
Reporting of adverse events, deviations, or other
audit/compliance issues, regulatory documents, monitoring and
special reporting questions |
Mary Williams |
mwillia2@bidmc.harvard.edu
|
7-3743 |
|
Clinical Trials registration on Clinicaltrials.gov |
Annette Douglin |
adouglin@bidmc.harvard.edu |
7-4113 |
|
Research involving vulnerable populations: children,
pregnant women, neonates, fetuses, individuals with diminished
mental/cognitive capacity |
Dan DeHainaut |
ddehaina@bidmc.harvard.edu |
7-4097 |
|
Industry contracts, budgets, NOGAs and final IRB approval |
Susan Yuen-Lee |
syuenle@bidmc.harvard.edu
|
7-1831 |
|
Research subject complaints |
K. Babu Krishnamurthy |
bkrishna@bidmc.harvard.edu
|
7-4088 |
