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IRB approval obtained - the protocol is IRB approved by the single IRB and local IRBs/Ethics Boards (for international sites) before study procedures, such as data collection/entry take place. This includes updating legacy protocols with DMCC transition language before new data is entered in the database.
REDCap users trained - Users must be appropriately trained on the protocol. Anyone who will access the database needs to be trained on the protocol specific REDCap database before being given access by the DMCC. These trainings are posted on the RDCRN Members Page; your DMCC Project Manager or Consortium Project Manager will assist in providing instruction regarding these trainings.
REDCap users on Delegation of Authority Log - Users must be delegated tasks appropriately for their role (i.e. data entry for those who will need access to modify data in the database) and this must be reflected on the Delegation of Authority Log in the regulatory binder.
Special considerations for “Broad Users” -
“Broad Access” means access to REDCap data across multiple sites in addition to one’s home site’s data; typical roles for this access type include: Consortium Project Manager, Statistician, Data Analyst. When requesting this type of access for yourself or another study team member, please keep in mind:
The consent and protocol must be written in such a way that permits the sharing of PHI with collaborators across sites (if PHI is entered into REDCap database)
The appropriate legal documentation (e.g. DUA, DHA) should be in place between the DMCC and the individual sites
The user receiving broad access is listed on the protocol Delegation of Authority Log and has been delegated this type of role/access (e.g. statistician/data analyst)
If broad user needs write access at their home site, broad user should attest that they will not modify data at other sitesStudy personnel who have write/edit access for site-level data for all sites participating in a study must have the authorization from the protocol PIs at each site to have write/edit access to their site-level data. To ensure that this authorization is in place, the protocol must include a statement specifying the role(s) of the individual with such access. The specific individual(s) fulfilling that role must be included on the Delegation of Authority log at the site where the individual(s) requiring write/edit access are based.
The provision of broad access to this user must comply with your consortium’s data sharing processes/policies (e.g. executive committee approval was obtained/documented by consortium administrative core, DUAs within the consortium)
Subsequent users (i.e. users added after initial user gathering process at database launch) – The Consortium/Site PI or Consortium PM may request that users be added after the initial user list is obtained. It understood by the DMCC that the above expectations were considered by the consortium study team when adding subsequent users.
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