All Biorepository samples are paired with a minimal amount of clinical data. All samples and data are coded at the time of release to the investigator. It is the responsibility of the investigator to obtain IRB approval for the data they are requesting and obtaining from the Biorepository and/or the CDW. The Biorepository team will request documentation of IRB approval before any data are released.
Prospective cohort samples
All cohort participants are administered a questionnaire. The questionnaire covers COVID risk factors (e.g., travel, essential work, exposures), signs and symptoms, medical and social history, and substance use. Additionally, a variety of clinical variables are abstracted from the electronic medical record (EMR) for all cohort participants.
Questionnaire data dictionary
EMR data dictionaries:
REDCap questionnaire data dictionary (Excel doc)
Before submitting a request for prospective cohort samples, investigators are encouraged to consult with the Biorepository team to discuss if the available data will meet their needs. If an investigator requires data beyond the standard variables provided above, it is their responsibility to obtain it (e.g., consult with the Clinical Data Warehouse [CDW]). The Biorepository team can consult further on the suggested process. Investigators can schedule a consult by contacting the SRC.
Discarded clinical samples
The following variables are paired with each discarded clinical sample in the Biorepository:
- Date of sample collection
- Type of sample
- Patient’s COVID status (+ or -)
- Date of patient’s first positive COVID test
- Day of illness at time of sample collection (i.e., days form first positive test to sample collection date)
Many investigators will require clinical data beyond the list of variables above, for instance to determine samples of interest (e.g., eligibility criteria) or stratify data for analyses. This may require access to PHI (see more below) and additional manual chart review or collaboration with the CDW. Before submitting a request for discarded clinical samples, investigators are encouraged to consult with the Biorepository team to discuss data needs. If the investigator anticipates needing data beyond the variables listed above, the CDW team will be invited to the consultation. Investigators can schedule a consult by contacting the SRC.
Protected Health Information (PHI)
All Biorepository samples and data are released to investigators coded with unique IDs. However, if an investigator wishes to connect a sample with clinical data beyond that which is provided, they must obtain institutional review board (IRB) approval to obtain these data and link them to Biorepository samples with PHI. Additional clinical information may be obtained either through the BMC Clinical Data Warehouse (CDW) or through manual chart abstraction. For example, if an investigator wishes to obtain discarded clinical samples from patients with severe COVID disease, they must obtain IRB approval to identify these patients and use PHI to link their medical record with the Biorepository. The investigator would provide the MRN and/or sample accession number(s) to the Biorepository to identify the samples within the inventory.
Similarly, but conversely, an investigator may wish to obtain a certain type of sample from the Biorepository then link these samples to the EMR. The investigator must obtain IRB approval to use this method. An investigator wishing to link samples to PHI must provide an attestation to the Biorepository that they have received IRB approval to do so.
BMC Clinical Data Warehouse (CDW) Application
The CDW Data Request Form can be found here.