True 2.0 Best Practices
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.
We are committed to start working on your submissions as soon as possible; however, this is not always possible.
Here are some areas in which we can work together to improve our response time to your submissions:
• It is essential to have PI and IRB Director’s attestations regarding therapeutic intent of our Phase I studies; please try to include those attestations with your submissions, if/when possible.
• IND or IDE related information (e.g. FDA letters) are necessary for us in the process of making our coverage determination. Please provide those with your submissions, if/when available.
• Please make sure you are including both CRO and sponsor information with your submissions. It is important for us to identify the sponsor as well as the appropriate negotiation contact as soon as possible.
• Please include Lab Manuals, Pharmacy Manuals, and Investigator Brochures When/if such documents are referenced in the study protocol. In many cases, sponsors don’t have these documents ready at the outset; however, Please request them as soon as you see them referenced in the protocol.
• Please make sure you are selecting a recipient from our office, when you are submitting a comment through True 2.0. Our system does not issue notification when there are no recipients selected.
Studies on Hold
Please note that we will start working on any and every complete submission (i.e. all smart form questions have been answered) that includes the mandatory documents.
Please don’t click on “Submit to HRA” (i.e. submit your study), if you are not ready for us to start working on your submission. This is because we want to make sure that we are using the final version of mandatory documents in our processes.
In addition, we will send the following submissions back to “Returned to Presubmission” in True 2.0. You will need to resubmit, (i.e. Submit to HRA in True 2.0) when your submission is ready for our processing.
- On hold due to FDA review
- On hold due to sponsor for more than a month or when there is an expectation of change in the study protocol
- On hold due to PI not being ready to move forward
- On hold due to unavailability of funds