Page:V-safe Pregnancy Registry Protocol, Version 2.pdf/7

v-safe pregnancy registry protocol: March 18, 2021, version 2 Analysis plan:

Data from the pregnancy registry will be analyzed monthly at a minimum; reports will include descriptive analyses of any adverse outcomes and rates of follow up among pregnant persons. Specifically, we will calculate rates of fetal demise (spontaneous abortion and stillbirth), pregnancy complications (pregnancy induced hypertension, gestational diabetes, pre-eclampsia), adverse birth outcomes (preterm delivery, small for gestational age, low birth weight, neonatal intensive care unit stays), major birth defects, and other outcomes of interest. These proportions may be compared to national averages, published background rates or estimates seen in other data systems. Adverse events may be analyzed in aggregate if rare (i.e., any major cardiac defect). Any potential signals will be compared to other surveillance systems, such as VAERS, and specifically for birth defects, the CDC’s Metropolitan Atlanta Congenital Defects Program or the Texas Birth Defects Registry. Persistent signals will be evaluated in more robust database systems (such as the Vaccine Safety Datalink) that have denominator data of pregnant persons who received COVID-19 vaccines and comparison groups of pregnant persons who did not receive COVID-19 vaccines. For rare outcomes, evaluations may also be conducted in other database systems, such as the FDA or the Department of Defense (DOD), for appropriate follow up assessment.

Data quality, and management:

V-safe data will be collected, managed, and housed on a secure server by Oracle. Through Health and Human Services (HHS), Oracle has donated IT services to any agency conducting COVID-19 related activities. Oracle is providing IT support for v-safe. All VSAFE data is collected, stored, processed and transmitted in Federal Risk and Authorization Management Program (FEDRAMP) approved infrastructure environment (10).

CDC ISO data managers will create a dataset for the VAERS/v-safe pregnancy call center which includes only those participants who report potential pregnancies. V-safe pregnancy registry data obtained in phone calls and medical records will be stored on an internal CDC server. Data from all components of the v-safe pregnancy registry may be combined into a master dataset behind the CDC firewall using unique identification numbers assigned at registration.

Pre-approved CDC investigators and data managers, including CDC contractors, will be the only individuals with access to the full data. All electronic documents, data sets, and files relevant to the project will be stored on network folders with restricted access on CDC computers. The v-safe team at CDC will be primarily responsible for data management activities, including data extraction, documentation and archival of a final data set. The archive will include the protocol, statistical programs, human subjects review documents, statistical output, analytical data sets, and manuscripts. Data sharing plans will be developed at the completion of data collection.

Human subjects considerations and confidentiality

This protocol will require human subjects determination at CDC because CDC is the lead site and surveillance data will include collection of personal identifiable information (PII). This data will be collected for public health surveillance, not for research purposes. No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.