| Initial Review |
|
Initial review (protocol)*
- For single site submission investigator cost is included
- For single site located in Massachusetts add additional $100
|
$1650 |
|
Initial review (investigator – multi-site only)*
(add additional $100 for Massachusetts investigators) |
$650 |
|
*Fee includes one informed consent document (ICD), please
add $300 for each additional |
|
Board/consultant advisory opinion (e.g., draft protocol) |
$500 |
|
| Modifications After
Initial Review |
|
|
Protocol amendment (no revision to the ICD) |
$300 |
|
Protocol amendment (revision to the ICD) |
$300 + $300 per
Revised ICD |
|
Additional ICD |
$300 |
|
Review of new or revised recruitment material |
$100 per item |
|
Revised ICD (i.e., additional site/change in site, PI change,
or payment section) |
$300 per ICD |
|
Continuing review report (protocol) - single site* or first
site for multi-site |
$900 |
|
Continuing review report (investigator) (add additional $100
for Massachusetts investigators)* |
$650 per PI |
- Site expiration reminder notice
|
NO CHARGE |
|
Revised product information (i.e., investigator’s brochure,
package inserts, annual progress reports) - acknowledgement letter |
$400 |
|
Letter generation & distribution (per site) |
$100 per letter |
|
Unanticipated problem review (safety reports, SAEs, etc.) |
NO CHARGE |
|
Final report |
NO CHARGE |
|
| Additional Services
and Considerations |
|
Investigator training |
NO CHARGE |
|
Toxicology reports (first use in human studies) |
NO CHARGE |
|
Certified translation services (please request back translation
if needed) |
Cost + $100 |
|
Unscheduled meetings (if requested and accepted by RCRC IRB) |
$3000 |
|
Late fee for research submitted after deadline (if accepted
by RCRC IRB) |
$750 |
|
Duplication/distribution cost |
$50 per document |
|
Site visits: i.e. Board requested, for cause or Massachusetts |
Cost + 25% admin fee |
Archive retrieval per box |
$50 ($100 Rush) |
Volume discounts may apply for multi-site studies.
