Frequently Asked Questions
Study teams at the University of Pittsburgh or UPMC who are conducting or planning to conduct human participant research or basic/pre-clinical research related to COVID-19 must complete the submission form. Research teams who are amending a research study to include COVID-19 measures should also complete the COVID-19 research submission form.
Research studies that do not include a COVID-19 component do NOT need to be submitted. CTSI is only collecting information from research studies related to COVID-19.
UPMC and the University of Pittsburgh created a central process to coordinate biospecimen collection and clinical trials for COVID-19 patients. Please see below.
Biospecimen collection from COVID-19 patients
An institutional biorepository led by Drs. Alison Morris and Bryan McVerry has been established by UPMC to centralize biospecimen collection from patients admitted to UPMC Presbyterian Shadyside with COVID-19, both on the inpatient floors and the intensive care units. Samples will be collected, processed for plasma, serum, and cellular components, and stored in central locations for access by Pitt investigators. As samples are limited, specimen and assay requests beyond the standard dataset will be reviewed by a biospecimen committee, and disbursements will be made accordingly. Per EH&S guidelines, all sample processing must be performed according to BSL-2+ or BSL-3 standards depending on the proposed assay. A formal request mechanism for biospecimens is now available. Please contact Dr. Alison Morris, firstname.lastname@example.org for more information about access to biospecimens.
Clinical Trials involving COVID-19 patients
UPMC has recently launched a COVID Resources Portal to collect common data elements using a standardized intake form for COVID-19 patients. These data, which will be made available to investigators, support the REMAP-COVID platform trial for studying therapeutic interventions for patients infected with SARS-CoV-2. This platform centralizes recruitment of participants for all clinical research and trials for COVID-19 patients. All clinical trials and studies for COVID-19 patients must use the COVID Resources Portal and harmonize with the REMAP platform for potential enrollment. Studies will be reviewed by a coordinating committee created by UPMC. Investigators seeking access to COVID-19 patients for clinical trials and research studies can contact Dr. Bryan McVerry at email@example.com.
If the study is specific to COVID-19, you must include “COVID-19” in the study title. This will expedite the protocol through the review process.
If you are submitting a modification to add a COVID-19 component to a study that is not specific to COVID-19 (e.g., adding a COVID-19 question to a diabetes survey study), the study title does not need to be changed. You should, however, send a comment to the IRB to let them know about the addition of a “COVID 19 component.”
The Office of Sponsored Programs and Research Support (OSPARS) is responsible for facilitating the review, execution, and approval for all industry-initiated clinical trials at UPMC as well as investigator-initiated studies led by non-University investigators/staff (e.g., UPMC physicians not having a University of Pittsburgh affiliation, private physicians having no University affiliation).
The Office of Sponsored Programs (OSP) is responsible for assisting University of Pittsburgh faculty, staff, and students in their efforts to promote and secure sponsored research funding. OSP also processes Data Use Agreements (DUAs) and Material Transfer Agreements (MTAs) for studies sharing data and/or biospecimens or other materials.
If your company is offering a digital product, service, or solution, please contact Kate Ledger at firstname.lastname@example.org with the University of Pittsburgh’s Office of Communications. If your company is offering scientific or clinical solutions, please contact email@example.com. Please note that CTSI staff do not have the authority to make financial decisions regarding software tools for the University.