2023 Precision Medicine SymposiumRegister
How does the PMAP work with IRB and Data Trust Risk Tiers?add
The Johns Hopkins School of Medicine IRB has worked with the Data Trust to streamline review processes for study protocols which use highly secure environments. Review the three tiers of risk for research and quality projects. Tier A requires no Data Trust review by default. Tier B may or may not require Data Trust review. Tier C requires IRB Data management review and/or IT security review and is likely to require Data Trust review. In order to estimate the risk tier, please use the risk calculator which will eventually be incorporated into the eIRB workflow.
How do I find the data I want in the Data Catalog, if I don't know exact table names?add
The PMAP Data Catalog uses tags to assist with catalog searching, so that users of the catalog do not need to know exact table and field names in order to find entries of interest. Example tags include: Demographics. Labs, Medication, Vital, Biospecimen.
How does the PMAP handle restricted data?add
PMAP Data Management team experts will provision data based on certain aspects of the data sets. These include restricting access to research data collected as part of an active protocol, only provisioning Protected Health Information (PHI) with prior approval, and restricting access to sensitive data elements (e.g. HIV, psychiatric, and opioid use) unless the requestor has prior permission to receive these sensitive data elements.
How is protocol-specific data handled in the PMAP?add
Data collected as part of an active study protocol is kept in its own secure segment in PMAP separate from other data. Data from that protocol will only be provisioned to other investigators with approval from the PI of the protocol as well as approval from the IRB. Once the study protocol is no longer active, restrictions on accessing the data set will be removed and the data will be treated just like any other data in PMAP.