Schulman strives to provide timely full Board reviews and expedited reviews without compromising the quality analysis the regulations require.
Schulman can provide expedited review services for elements of research involving no greater than minimal risk. The following items may be reviewed by expedited review: recruitment materials, study-related materials, translated materials,qualifying new protocol submissions and some amendments.
Specific turnaround goals are listed below.
Please note: Turnaround time is dependent upon complete and accurate submission of study documents and your response to any Board inquiries.
|Review Item||Turnaround Time||Important Notes|
|New Protocol and Initial IC for Multisite Studies|
(Full Board Review)
|3-5 business days||From time of receipt at Schulman to full board review.|
|New Protocol and Initial IC|
(Minimal Risk Review)
|1-2 business days||From time of receipt at Schulman to board member review.|
|New Site for a Multisite Study||1 business day||From receipt of submission to release of approval documents.|
|Study Status Notification||1 business day||E-mailed to study contact after board has reviewed the new study.|
|Recruitment Materials*||2 business days||From time materials are prepared for board review to distribution.
|Study-Related Materials*||2 business days||From time materials are prepared for board review to distribution.|
|Translated Initial Informed Consent||5 business days||After English version has been approved.|
Depending on the nature of the protocol change, an amendment may qualify for expedited review or may require full Board review.
*For an additional fee, Schulman can provide rush review services for recruitment and study-related materials. Rush review materials will be reviewed and returned to the client within one business day of receipt. Need a rush review service for specific items? Contact Business Development.