Pfizer: End-to-End View of Covid Vaccine Manufacture and Distribution
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Study Submission
To request CTO Services, clinical trial protocols must be submitted via TRUE 2.0, the University’s clinical trial approval and tracking system.
Mandatory Documents
When you have agreed to participate as a site, please submit to the Clinical Trials Office the mandatory documents below:
- Clinical Trial Protocol (most recent version, including any Amendments)
- Sponsor Budget
- Clinical Trial Agreement (CTA)
- Informed Consent Form (ICF)
- Investigator Brochure (drug) and/or Device Brochure
- Laboratory Manual
We no longer accept any submissions that do not include the above documents.
To improve CTO’s response time and study activation, the following documents are also required, if applicable:
- PI and IRB Director’s attestations regarding therapeutic intent for Phase I studies
- IND or IDE related information (e.g. FDA letters)
- Pharmacy Manuals when referenced in the study protocol. In many cases, sponsors don’t have these documents ready at the outset; but they should be requested and submitted to CTO upon receipt.
Upon receipt of the mandatory documents, the clinical trial will be assigned to a Contract Manager and MCA Administrator to initiate the coverage analysis and negotiations with sponsor.
Below is an overview of the current process: