Protocol amendments with billable services should be submitted to the CTO by using the Amendment Submission Form. To help you determine when an amendment should be submitted to the CTO, we provide some examples below.
Before you submit an amendment to the CTO, please review the CTO's process for review of protocol amendments for more detailed information.
CTO review is required when the amendment results in a revision to the MCA billing plan.
- The following are examples of protocol revisions that require CTO review:
- Addition/change/deletion of billable services
- Addition/change/deletion of visits
- Addition of inclusion/exclusion criteria that requires services to be added to a screening visit, e.g., HIV screening, HEP B, HEP C, chemistries, hematology
- Addition/change/deletion of footnotes
- The following are examples of protocol revisions that do not require CTO review:
- Dosage/formulations/storage of study drugs
- Administrative revisions, e.g., revision to personnel, addresses
- Inclusion/exclusion criteria, e.g., prior medications, histories, revisions to lab test results
- Drug storage conditions
- Survival follow-up requirements that are non-billable
- Study questionnaires
Amendment Submission Form
Use the Amendment Submission Form to upload amended protocol, model consent, and other study materials.
Consistency Check Submission
Use the Consistency Check Submission to upload consent for consistency check against MCA, contract, and budget.