Revised Compensation/Reimbursement Form

1.Submission information: Use this form to submitrevised compensation for participation/reimbursement for expenses information to be included in the site-specific informed consent (IC).
2.Submission instructions: Submitvia Secure eSubmissionor email to .
SECTION 1.0: Study & Contact Information
1.Date: / 2.IRB No.:
3. Sponsor: / 4.Protocol No.:
5. PI/QI Name:
6.Contact information for this submission:
Name: / Company:
Phone: / Email:
SECTION 2.0: Compensation/Reimbursement Information
1.What type of revised compensation/reimbursement information is being submitted? Check all that apply:
Change to current compensation/reimbursement amounts Provide the rationale:
New compensation/reimbursement related to a protocol revision/amendment
New compensation/reimbursement related to sub-study participation Specify sub-study:
New subject specific compensation/reimbursement Provide the subject number(s):
Other:
Note: Sponsor/CRO approval may be needed to process the request. To avoid delays, attach sponsor/CRO approval, if applicable.
2. Who will receive compensation/reimbursement? Check all that apply:
Adult Subjects / Minor Subjects and/or their Parents/Guardians / Caregivers / Other:
3. List all ICs for the study that will be revised by this request:
4. Attach the new and/or revised visit compensation/reimbursement schedule. Specify any visits for which the subjects will NOT be compensated/reimbursed. Examples of visit types that should be addressed are:
  • Screening
/
  • Completed
/
  • Inpatient/Confinement
/
  • Telephone

  • Unscheduled
/
  • Optional
/
  • Sub-study
/
  • Subjects serving as alternates

Note: To avoid delays in processing, refer to the visit schedule in the study protocol to ensure all vists are addressed.
5.Does this revision change when compensation/reimbursement will be provided to subjects?
No / Yes Complete a.:
a. Compensation/reimbursement must be prorated across study visits. When will compensation/reimbursement be provided to subjects?
after each visit / monthly / at the time participation in the study ends*
weekly / annually / other:
*Compensation/reimbursement must be provided at least annually for participation lasting longer than 1 year.
6. If the compensation/reimbursement amount is decreasing, confirm currently enrolled subjects will continue to receive the higher amount in their IC:
Yes / N/A – amounts are not decreasing
7.Specify one of the following regarding IC translation:
No IC translation is needed.
I will obtain my owntranslation through a certified translator and provide for Schulman review prior to use.
I authorize Schulman to translate the IC and the associated cost for: All previously translated languages
Only specified languages:
Note:Confirm authorization for translations with the sponsor/CRO prior to submission, if necessary.
Version:April 17, 2015* / © 2015Copyright SCHULMAN / Page 1 of 1