To expedite Clinical Trial Acceptance in TRUE 2.0, please ensure the below documents, at minimum, are included in every submission:
- Clinical Trial Agreement (CTA)
- Sponsor Budget
- Clinical Trial Protocol
- Informed Consent Form (ICF)
We accept draft documents in any format (Word, Excel, etc.); however, we need the most recent versions provided by the Sponsor, including any Amendments to the Protocol, etc.
Since we need the above to begin developing the Coverage Analysis and Budget, we will no longer be accepting any submissions that do not include the above documents. The submission will be returned to “Presubmission”. Once the documents are obtained and attached, you can simply resubmit the study and we will move forward with preparing the Coverage Analysis, Budget and CTA.